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Research Studies: Depression

DBSA does not endorse nor recommend any particular research study. Patients should discuss all options with their health care providers and family members before beginning any study.

Many people think that participating in a research study means they will get better treatment for their illness. While this may be true, it's important to remember that a research study is conducted for research purposes—it does not ensure better or safer treatment.

Taking part in a study does not guarantee individual benefits to the participant in the form of newer or safer treatment. The contribution made participating in a research study is to science first and to the patient second.

DBSA, its advisors, and its consultants do not endorse or recommend the use of any specific treatment or medication. For advice about specific treatment or medication, patients should consult their physicians and/or mental health professionals.


Familial Early-Onset Suicide Attempt Biomarkers with PET/MRI (New York, NY)

Depression affects 15 million Americans each year. More than 44,000 Americans die by suicide each year. Depression and suicidal behavior risk are transmitted in families due to a combination of genes and environment. Depressive illness and the risk of suicidal behavior are associated with altered brain function that we can detect by brain imaging.

A research study is being conduced at Columbia University Medical Center that aims to examine brain function in adults who have a parent or sibling who has suffered from depression and made a suicide attempt. You may be eligible if you are between the ages of 25 and 60 years old and have lost a first degree relative to suicide.

The goal of the study is to detect who is at risk of developing depression and who is not going to develop depression so we can prevent these problems before they occur. Your participation could help researchers better understand the causes of suicidal behavior and depression and help others who suffer from depression in the future.

Procedures include brain imaging (MRI and PET), neuropsychological testing and a detailed clinical assessment. The compensation for participating is up to $600.

Patients are expected to be medication free for brain scans.

Participants will complete research procedures and then may start antidepressants upon completion of research procedures if they'd like. They are offered 6 months of open medication treatment through our clinic at no cost.

Contact
Allison Metts
646-774-7560
almetts@nyspi.columbia.edu

Deadline for Enrollment: April 2020


VLZ-MD-22 (Lauderhill, Florida)

A multicenter, double-blind, placebo-and active-controlled parallel-group evaluation of the safety and efficacy of Vilazodone in pediatric patients with major depressive disorder. Participants must wash out of current psychiatric medications; cannot initiate or terminate psychotherapy, but can maintain current psychotherapy as long as it has been consistent for 3 months. The chances of placebo are 1 out of 3 or 33%. The placebo period will last 9 weeks.

Contact
Paul Martin
305-722-8444
segaltrials@gmail.com
www.segaltrials.com

Deadline for Enrollment: 04/30/17


Mechanism of Antidepressant-Related Dysfunctional Arousal in High-Risk Youth (Cincinnati, Ohio)

The purpose of this research study is to investigate brain changes in adolescents who are currently experiencing depressive and/or anxiety symptoms and have a family history of bipolar disorder.  Participants will be randomized to escitalopram and psychotherapy or placebo and psychotherapy for 16-week treatment.

Participants will receive compensation for their transportation and/or time for the study visits. All study visits, tests, procedures and medication will be provided at no cost to participants. No other antidepressant use is permitted. Adolescents 12 to 17 years of age who are experiencing depressive and/or anxiety symptoms or have been diagnosed with depression and/or anxiety and have a first-degree relative (parent or sibling) with bipolar I disorder may be eligible to participate.

Contact
Kaitlyn Bruns
513-558-5303
brunskn@ucmail.uc.edu

Deadline for Enrollment: 6/1/2020


Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Flexible Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression (Chicago, IL)

The current study is being conducted to evaluate the efficacy, safety, and tolerability of flexibly dosed intranasal esketamine plus a newly initiated oral antidepressant in adult participants with TRD. The study will serve as a pivotal Phase 3 short-term efficacy and safety study in support of regulatory agency requirements for registration of intranasal esketamine for the treatment of TRD.

A placebo group is used in this research study. Potential participants are randomized in a 1:1 ratio per the study protocol.

Contact
James Mateka
773-282-9845
james.mateka@chicagoresearchcenter.com

Deadline for Enrollment: 12/31/2017


Research on Reward Learning and the Brain (Belmont, MA)

Have you ever felt sad, blue or down? Are you currently not experiencing symptoms of depression? McLean Psychiatry researchers seek volunteers to understand how we process rewards in the brain. The study includes two sessions: the first session takes place at McLean Hospital in Belmont, the second session at the Neuroimaging Center on the McLean Campus. If eligible to participate, receive up to $176.

We are seeking right-handed individuals, 18-45 years old, with no past psychiatric or neurological illness other than depression. Individuals who are currently taking psychotropic medications will not be eligible. If you are interested in participating, please complete the following screening survey: https://redcap.partners.org/redcap/surveys/?s=7dQhyd.
All information will be kept strictly confidential to our research study staff and information obtained in this survey will be used for research recruitment purposes only. If you are a good match for the study based on this survey, a research coordinator from our lab will contact you.

Contact
Sherry Jiang
617-855-4431
yjiang@mclean.harvard.edu
http://cdasr.mclean.harvard.edu

Deadline for Enrollment: August 2017


Reward Processing in Unipolar and Bipolar Depression (Belmont, MA)

Researchers at McLean Hospital are currently recruiting individuals who are experiencing symptoms of depression or bipolar disorder, for an exciting new study that uses brain imaging to identify the ways different people will respond to reward, and how this relates to disturbances in circadian rhythms.

We are seeking right-handed individuals, 18-45 years old, with no serious medical or neurological illness other than depression or bipolar disorder.

This study consists of 2 sessions that each last between 1-3.5 hours. During these sessions participants will receive brain scans using MRI (a non-invasive brain imaging technique), and will also receive a comprehensive clinical assessment from a trained clinical interviewer. If eligible to participate, individuals can earn up to $245.80.

If you are interested in participating, please complete our online screening survey at www.mcleanstudy.org.

Contact
Sherry Jiang
617-855-4431
yjiang@mclean.harvard.edu

Deadline for Enrollment: August 2017


Examining Mechanisms of Change in Behavioral Activation Treatment for Anhedonic Adolescents (Belmont, MA)

Has your child been feeling down, depressed, or has been experiencing less pleasure in the things they used to enjoy?

If so they may be eligible for this study, which provides 12 weeks of free psychotherapy and up to $330.

Researchers at McLean Hospital are investigating factors that put individuals at risk for symptoms of depression. By participating, you and your child can help them better understand, treat, and prevent adolescent depression.

Note: Participants will be given 12 weeks of free psychotherapy and can therefore not be receiving other forms of therapy or on psychotropic medication.

Contact
Lindsay Appleman
Phone: 617-855-4195
Email: lmappleman@mclean.harvard.edu

Deadline for Enrollment
12/13/2017


Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant (Hoffman Estates IL)

A Randomized, Double-blind, Multicenter, Active-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Fixed Doses of Intranasal Esketamine Plus an Oral Antidepressant in Adult Subjects with Treatment-resistant Depression

There are three phases in this study:

  • A screening phase of up to 7 weeks
  • A 4-week treatment phase
  • A 24-week follow-up phase 

Some participants will be given the option to continue treatment in another study and will not have a follow-up phase.

ECT, DBS, TMS, and VNS are prohibited from study entry through the end of the double-blind induction phase Subjects receiving psychotherapy (including cognitive behavioral therapy; CBT) can continue receiving psychotherapy.

Participants will be randomly assigned at a 1:1:1 ratio to receive double-blind intranasal treatment with either esketamine 56 mg, esketamine 84 mg, or placebo. All participants will be on an oral antidepressant in addition to the study drug or placebo.

Contact
Linda Orgler
Phone: 847-230-3591
Email: psychresearch@amitahealth.org

Deadline for Enrollment: 10/31/17


Engage MDD Studies (Multi-centers in the U.S.)

A Multicenter, Double-blind, Placebo- and Active-Controlled Parallel-Group Evaluation of the Safety and Efficacy of Vilazodone in Pediatric Patients With Major Depressive Disorder

The Engage clinical research studies are for children and adolescents with MDD. The purpose of the studies is to find out whether two different investigational drugs are safe and effective for children and adolescents who have MDD. Your child may be able to join an Engage clinical research study if he or she:

  • Is 7 to 17 years old
  • Has been diagnosed with MDD or has been having feelings of depression

There are other eligibility criteria that your child must meet to participate in an Engage clinical research study. The study staff can discuss these criteria with you in greater detail.

Restrictions: Patients initiating individual psychotherapy or behavior therapy within 3 months prior to the Screening (Visit 1), or who plan to initiate or change such therapies during the course of the study.

Participant will randomize into 1 of 3 groups.
Groups:
Group 1-Fluoxetine
Group 2 -placebo
Group 3-investigational drug
It will last 8 weeks.

Contact
Mary Tabakin
Phone: (240) 747-1703
Email: EngageMDDStudies@mmgct.com
engagemddstudies.com

Deadline for Enrollment: August 2018


Genetic test using DNA to help find the most appropriate treatment for your depression (Chicago, IL)

This is a 24-week study of a genetic test used to predict which drugs and doses for the treatment of depression are likely to work best for a particular person. This study will involve using a cotton-tipped swab to collect a saliva sample from the inside of the patient's check. The study lab will analyze the sample and provide a report for the study doctor to use in selecting medication. The report will show commonly prescribed psychiatric medications grouped into categories based on the subject's unique profile.

Possible restrictions on receiving other treatments.

Contact
Linda Skaggs
Phone: 312-942-5592
Email: linda_m_skaggs@rush.edu


Observational study to evaluate potential predictors of relapse in subjects with major depressive disorder (Chicago, IL)

This is a study of subjects with major depressive disorder who are responding to treatment with an oral antidepressant medication.  The purpose of this observational study is to evaluate whether answers to questionnaires about symptoms and functioning can be used to predict worsening of depression in the near future.  The length of study participation will vary, with study visits every 8 weeks until the required number of subjects experience a return of depression symptoms.

Possible restrictions on receiving other treatments.

Contact
Linda Skaggs
Phone: 312-942-5592
Email: linda_m_skaggs@rush.edu


Rapidly Acting Treatment for Depression (Chicago, IL)

We are doing this research study to find out if an investigational medication can help improve the symptoms of depression within the first 72 hours of treatment when combined with an antidepressant.  This study will enroll adults who have not sufficiently responded to treatment with antidepressants. We also want to observe side effects and safety of the investigational medication when used with an antidepressant.

Certain other treatments are not allowed. There is a 56% chance a subject will receive placebo during part of this study. There is a 19% chance a subject will receive only placebo during this study.

Contact
Linda Skaggs
Phone: 312-942-5592
Email: linda_m_skaggs@rush.edu


A prospective Longitudinal, Observational Study to Evaluate Potential Predictors of Relapse in Subjects With Major Depressive Disorder Who Have Responded to Antidepressant Treatment (Skokie, IL)

This observational study (data collection process) is being conducted in order to collect information related to Major Depressive Disorder, to identify those characteristics that may be used to predict worsening of MDD in the near future. For persons currently taking an antidepressant and doing well. Must have initiated and responded to an oral antidepressant with in the past three months. Subjects will receive a smart phone device and wrist device and complete questionnaires at various time points during the study. Qualified subjects may remain under the care of their current doctor throughout the study or begin treatment with our study team. Those currently receiving stimulants, anti-convulsants, or mood stabilizers for treatment of depression will not qualify.

Contact
Rae K. Watkins PsyD
Phone: 847-484-1900
Email: rae_watkins@rush.edu
www.psycsolutions.com

Deadline for Enrollment: December 31, 2018


Using Diazoxide with Treatment Resistant Depression (Bethesda, MD)

Is Your Depression Treatment Resistant? We are conducting this study to see if diazoxide can quickly improve depressive symptoms in people with treatment-resistant major depressive disorder (MDD).

Adults 18 to 65 years old with MDD, who are currently depressed without psychotic features  will be enrolled and hospitalized for the entire study. They may be allowed short leaves.

This research aims to see if diazoxide (an enhancer of glutamate transporter function) versus placebo can rapidly improve overall major depressive symptoms in patients with treatment-resistant Major Depressive Disorder (MDD). Other goals of the study include: evaluating diazoxide's effect on glutamate levels in the brain, determining whether changes in brain neurochemicals correlate with antidepressant response, and examining other biomarkers of response.

This inpatient study is assessing the effectiveness of the oral medication diazoxide (an enhancer of glutamate transporter function) versus placebo to rapidly improve hard-to-treat major depressive symptoms. The study enrolls eligible participants ages 18-65, who are diagnosed with Major Depressive Disorder (MDD), have previously failed to respond to treatment, and are free of other serious medical conditions.

This study can last up to 12 weeks and is conducted at the NIH Clinical Center in Bethesda, Maryland. There is no cost to participate. We enroll eligible participants locally and from around the country. Travel arrangements are provided and costs are covered by NIMH (arrangements vary by distance). After completing the study, participants receive short-term follow-up care at the NIH while transitioning back to a provider.

Depressed people appear to have problems regulating levels of a brain chemical called glutamate than people who are not depressed. The drug diazoxide may help regulate glutamate levels in people with depression. Researchers want to know if it can rapidly improve depression symptoms. This would help many people with depression, because most medications take a long time to work.

Objectives: To see if diazoxide can quickly improve depressive symptoms in people with treatment-resistant major depressive disorder (MDD).

Participants will be interviewed many times during the study. They will also fill out questionnaires.

Phase I will last about 4 weeks. Participants will be screened with lab tests, and psychiatric and medical history and exams. Participants will slowly go off current medications. They will be drug-free for 2 weeks.

Phase II will last about 8 to 9 weeks. Participants will be monitored, answer questions, and give blood samples. They will drink a glucose drink, give saliva samples, and have scans of their brains taken. Participants will take the study drug daily by mouth for one 3-week session. They will take a placebo daily by mouth for the other 3-week session.

There will be a drug-free period of 14 to 21 days between sessions.

Inclusion Criteria:

  • Individuals 18 to 65 years of age.
    Women of child bearing potential must have a negative serum pregnancy test and confirmed (by the investigator) use of 2 effective methods of contraception (see below).
  • Each subject must be capable of understanding all required tests and examinations and sign an informed consent document.
  • Subjects must fulfill DSM-IV criteria for MDD, single episode or recurrent without psychotic features, based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P). Subjects must be experiencing a current major depressive episode of at least 4 weeks duration.
  • Subjects must have an initial score of at least 20 on the MADRS at screening and at baseline of study phase I.
  • Subjects must have a current or past history of lack of response to two adequate antidepressant trials (may be from the same chemical class) operationally defined using the modified-Antidepressant Treatment History Form (ATHF).

Exclusion Criteria:

  • Current psychotic features or a diagnosis of schizophrenia or any other psychotic disorder as defined in the DSM-IV.
  • Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine dependence) within the preceding 3 months.
  • Head injury that results in loss of consciousness exceeding 5 minutes (for the imaging component of the study).
  • Subjects with a DSM IV Axis II diagnosis of borderline or antisocial personality disorder.
  • Pregnant or nursing women or women of child bearing potential not using 2 medically accepted means of contraception (to include oral, injectible, or implant birth control, condom, diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).
  • Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  • Subjects with hyperthyroidism or clinical hypothyroidism.
  • Subjects with one or more seizures without a clear and resolved etiology.
  • Clinically significant abnormal laboratory tests (including blood glucose).
  • Diabetes
  • Fasting plasma glucose concentration > 120 mg/dl
  • Upright blood pressure < 60mmHg on three occasions 30 minutes apart (based on scheduled research measurements).
  • Treatment with a reversible MAOI within 4 weeks of study phase II.
  • Treatment with fluoxetine within 5 weeks of study phase II.
  • Treatment with any other disallowed concomitant medication 14 days before randomization.
  • Treatment with clozapine or ECT within 1 month of randomization.
  • Lifetime history of deep brain stimulation.
  • Subjects who, in the investigator s judgment, pose a current serious suicidal or homicidal risk.
  • Positive HIV test
  • Contraindications to MRI (metal in body, claustrophobia, etc)

Contact
Libby Jolkovsky, M.S.
Phone: 301-402-9347
Email: jolkovsl@mail.nih.gov
http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml

Deadline for Enrollment: 2018


The Neurophysiological Effects of Intravenous Alcohol as Potential Biomarkers of Ketamine's Rapid Antidepressant Effects in Major Depressive Disorder (Bethesda, MD)

We are conducting this study to see if the antidepressant effects of ketamine are different in those who have relatives with alcoholism. We will also test if depressed subjects who have relatives with alcoholism respond differently to alcohol. Finally, we will see if there are unique signatures in the response to ketamine and alcohol. This may help us develop a more personal approach to depression treatment.

Glutamate-based medications including the N-methyl-D-aspartate (NMDA) receptor antagonist ketamine result in rapid, robust and sustained (up to one week) antidepressant effects in randomized controlled trials in treatment-refractory unipolar1-3 and bipolar depression4, 5.  Previous work by our group has demonstrated that a family history of alcohol dependence predicts a more robust antidepressant response to ketamine in both treatment-resistant unipolar6 and bipolar7 depression.

Recently-detoxified alcoholics and affected first-degree relatives display blunted psychotomimetic, cognitive and other neuropsychiatric effects with a subanesthetic dose of ketamine.  Also, a family history of alcoholism alone predicts differential response to intravenous alcohol 8-10.  Based on our prior post hoc results, we seek to prospectively  demonstrate that a family history of alcohol dependence predicts a more robust antidepressant response to ketamine. We will also explore potential biomarkers of ketamine's antidepressant effects in treatment-refractory depressed patients at risk of alcohol dependence (using physiological and neurochemical responses to alcohol).

We are enrolling participants  ages 21-65 year old with treatment-resistant major depressive disorder without psychotic features patients in a current major depressive episode of at least moderate severity will be recruited and enrolled in this protocol.  All subjects must also be free of a lifetime substance use disorder diagnosis with the exception of a nicotine or caffeine use disorder) and will be psychotropic medication-free for at least two weeks prior to the first alcohol infusion.  negative subjects.

This study is a single-site, open-label protocol in psychotropic medication-free depressed subjects admitted to the Clinical Research Center  at the Mood and Anxiety Disorder Inpatient Research Unit (7-SE).  This protocol consists of two phases (Phase I and Phase II). The first phase consists of the medication taper and drug-free period.  The second phase will have three subphases: Subphase IIA infusion #1 with neurophysiological assessments), IIB alcohol infusion #2 during 7 Tesla-Magnetic Resonance Spectroscopy/Imaging (7T-MRS/I)] and IIC (subanesthetic/antidepressant dose ketamine infusion during 7T-MRS/I).

Inclusion Criteria:

  • Individuals ages 21 to 65 years of age.
  • A level of understanding sufficient to agree to all required tests and examinations, sign an informed consent document and verify understanding by a score greater than or equal to 90% on the consent quiz.
  • DSM-IV-TR diagnosis of MDD, single-episode (296.30) or recurrent (296.20) without psychotic features based on clinical assessment and confirmed by a Structured Clinical Interview for the DSM-IV- Patient Version (SCID-P). Subjects must be experiencing a current major depressive episode of at least 2 weeks duration.
  • Past failure of greater than or equal to two standard antidepressant trial based on the Antidepressant Treatment History Form (ATHF).
    MADRS score greater than or equal to 20 at baseline and the day of ketamine infusion.

Exclusion Criteria:

  • Inadequate knowledge of family mental and substance use history, e.g. adoption.
  • Current psychotic features or prior diagnosis of a DSM-IV-TR psychotic spectrum disorder, e.g. schizophrenia, schizoaffective disorder, bipolar I disorder with psychotic features, MDD with psychotic features, or bipolar disorder, e.g. bipolar I disorder without psychotic features, bipolar II disorder and bipolar disorder not otherwise specified (NOS).
  • Lifetime history of DSM-IV-TR drug or alcohol use disorder (except for caffeine or nicotine dependence), currently seeking or have a prior history of seeking help for alcohol problems, non-drinkers (no alcohol in the past year) and history of alcohol-induced flushing reactions.
  • Pregnant or nursing women or women of child bearing potential not using at least one medically accepted means of contraception (to include oral, injectable, or implant birth control, condom or diaphragm with spermicide, intrauterine devices (IUD), tubal ligation, abstinence or partner with vasectomy).
  • Serious, unstable medical conditions/problems including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease, e.g. uncontrolled asthma, uncontrolled hyper/hypothyroidism or active cancer.
  • Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
    Clinically significant abnormal laboratory tests.
  • Subjects with one or more seizures without clear and resolved etiology and head injury with loss of consciousness for > 5 minutes or requiring hospitalization.
  • Treatment with psychiatric medications, e.g. selective serotonin reuptake inhibitors, serotonin norepinephrine reuptake inhibitors, benzodiazepines and antipsychotics, at least two weeks of study phase II Treatment with fluoxetine within 4 weeks of study phase II.
  • Treatment with device-based treatment for depression, e.g. electroconvulsive therapy (ECT), transcranial magnetic stimulation (TMS) and vagal nerve stimulation (VNS), within 4 weeks of study phase II.
  • Lifetime history of deep brain stimulation.
  • Treatment with any disallowed concomitant medications.
  • Positive HIV test
  • Presence of ferromagnetic implants, e.g, heart pacemaker or aneurysm clip, or other contraindications to magnetic resonance imaging (MRI), e.g. claustrophobia or hearing loss.
  • Clinically-significant anatomical brain abnormalities detected on routine brain MRI.
  • Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of > 4.
  • Additionally, the Investigators may exclude or terminate any patient for clinical reasons.

Contact
Libby Jolkovsky, M.S.
Phone: 301-402-9347
Email: jolkovsl@mail.nih.gov
http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml

Deadline for Enrollment: 2018


Rapid Antidepressant Effects of Ketamine in Major Depressive Disorder (Bethesda, MD)

Bipolar disorder and major depressive disorder (MDD) are common, severe, chronic and often life-threatening illnesses. Impairment in physical and social functioning resulting from depression can be just as severe as other chronic medical illnesses. Recent preclinical and clinical studies suggest that the glutamatergic system is involved in the mechanism of action of antidepressants. In two separate trials, we tested riluzole (an inhibitor of glutamate release) and found it to have antidepressant properties in patients with MDD and bipolar depression (BD). In another study (Substudy 1), we found that the non-competitive NMDA antagonist (ketamine) was effective in treatment-resistant MDD. Ketamine resulted in rapid, robust and relatively sustained antidepressant effects. Response with ketamine occurred within 2 hours and last approximately 1 week. The current protocol consists of 6 subs tudies designed to address 6 major questions. Two of these studies (1 and 5) have met their enrollment quota and sufficient analyzable data has been obtained

Standard antidepressant medications can take weeks or months to achieve their full effects. Several studies seek to better understand the causes of depression and evaluate the mechanisms in the brain that are related to rapid antidepressant improvement. NIH studies enrolls depressed persons between the ages of 18 and 65 (or those with bipolar disorder who are currently in a depressive phase) for an inpatient period of 2- to 3-months.  Researchers will evaluate how the experimental medication ketamine, versus placebo, affects glutamate in the brain and whether a rapid reduction of antidepressant symptoms (within hours) can be achieved and sustained.

The studies are conducted at the NIH Clinical Center in Bethesda, Maryland.  There is no cost to participate. We enroll eligible participants locally and from around the country. Travel arrangements provided and costs covered by NIMH. (Arrangements vary by distance and by specific study.) After completing the study participants receive short-term follow-up care while transitioning back to a provider.

Participants who consent will have a multimodal MRI and MEG scan in the drug-free period before receiving the intravenous infusion of either ketamine or saline solution. They will repeat the MEG procedure 4-5 hours after each of the two infusions, and will repeat the MRI procedure between the day of infusion to two days following the infusion.

Participants who show an antidepressant response (50% reduction in MADRS) following infusion 1 or infusion 2 will undergo an interim assessment using the same MRI and MEG scan battery to assess relapse (if the response is lost) or sustained response (if the response is retained) 10 to 11 days post-infusion, depending on availability of scanning resources.   Non-responders will undergo the interim MRI and MEG scan sessions at 10 to 11 days post-infusion as scan-time allows.

In a subset of 26 participants, total sleep deprivation (TSD) for 40 hours (7am to 11pm the subsequent day) will be investigated at the behavioral and neural level as a rapid acting antidepressant prior to Phase II of this study.  Individuals who participate in this optional component of the subs study will require an additional 7 days for their drug free period. In the evening prior to the sleep deprivation period, participants will undergo a baseline 3T MRI (within 2 days of TSD) and a high field 7T MRI scan (within 2 days of TSD) to acquire images of the brain prior to sleep deprivation. This will be followed by one 7T scan after the sleep deprivation period toward the end of the 40 hour period, but before recovery sleep. During the MRI scan participants will play a simple reward-learning task and also perform a cognitive emotional task whereby emotional faces will be presented, while functional images are acquired. Additionally, two MEG scans and two sleep EEGs will be acquired to examine the electrophysiology of response and relapse. During the MEG scan participants will wear an MEG compatible EEG cap and leads. Total sleep deprivation will occur approximately 1 week following the beginning of the drug-free period.

Inclusion criteria for participants with MDD or BD

  1. Male or female subjects, 18 to 55 years of age.
  2. Age of onset less than 40 years of age.
  3. Female subjects of childbearing age must be using a medically accepted method of contraception.
  4. Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
  5. Subjects must fulfill DSM-IV criteria for Major Depression single episode or recurrent without psychotic features, or Bipolar Disorder (296.5 for Bipolar I Disorder or 296.89 for Bipolar II Disorder) without psychotic symptoms based on clinical assessment and confirmed by a structured diagnostic interview (SCID-P).
  6. Subjects must have an initial score on the MADRS of at least 20 at screening, and at baseline for Phase I of Substudy 4. Subjects with bipolar disorder must have a YMRS of 12 or less at baseline for Phase I.
  7. Current or past history of lack of response to one adequate antidepressant trial, operationally defined using the Antidepressant Treatment History Form (ATHF); a failed adequate trial of ECT would count as an adequate antidepressant trial.
  8. Current major depressive episode of at least 4 weeks duration.
  9. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.

Exclusion criteria for participants with MDD or BD

  1. Current psychotic features or a diagnosis of Schizophrenia or any other psychotic disorder as defined in the DSM-IV.
  2. Subjects with a history of DSM-IV drug or alcohol dependency or abuse (except for caffeine or nicotine    dependence) within the preceding 3 months. In addition, subjects who currently are using drugs (except for caffeine or nicotine) must not  have used illicit substances in the 2 weeks prior to screen and must have a negative alcohol and drug urine test (except for prescribed benzodiazepines) urine test at screening.
  3. Female subjects who are either pregnant or nursing.
  4. Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
  5. Presence of any medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  6. Clinically significant abnormal laboratory tests.
  7. Subjects with clinical hypothyroidism or hyperthyroidism.
  8. Subjects with one or more seizures without a clear and resolved etiology.
  9. Treatment with a reversible MAOI within two weeks prior to Phase I of Substudy 4.
  10. Treatment with fluoxetine within five weeks or aripiprazole within three weeks before Phase I of Substudy 4.
  11. Treatment with any other concomitant medication (Appendix 4) 14 days prior to Phase I of Substudy 4.
  12. Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
  13. Subjects who, in the investigator's judgment, pose a current serious suicidal or homicidal risk, or who have a MADRS item 10 score of >4.

Inclusion criteria for control subjects

  1. Age 18-55 years.
  2. Written informed consent completed.
  3. In women of childbearing age, a negative pregnancy test within 24 hours of MRI.

Exclusion criteria for control subjects

  1. Current or past Axis I diagnosis
  2. Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
  3. Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
  4. Treatment with any of the exclusionary medications detailed in Appendix 4 14 days prior to Phase 1 of the Substudy 4.
  5. Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
  6. Presence of psychiatric disorders in first-degree relatives.
  7. Female subjects who are either pregnant or nursing.

Contact
Libby Jolkovsky, M.S.
Phone: 301-402-9347
Email: jolkovsl@mail.nih.gov
http://www.nimh.nih.gov/labs-at-nimh/join-a-study/index.shtml

Deadline for Enrollment: 2018


Depression Research Study (Ann Arbor)

The purpose of this study is to examine the relationship between emotion and memory. The goal of this study is to try to understand how the brain processes information in those with Major Depressive Disorder by understanding how interference is resolved in perceptual, memory, and motor processes. This, in turn, may help us understand ruminative processes among depressed individuals.

In this study, participants will first be asked to undergo a clinical diagnostic interview with a trained clinician, graduate student, post docs, or other trained personnel who have undergone formal training in administering the interview. During that time we will ask you questions about your emotional and physical well-being. This interview, which will last approximately 1-2 hours, will help determine if participants are eligible to continue in the study. This session pays $20.00 an hour.

If eligible, participants will be invited back to participate in various studies, which include performing computer-based tasks. Participants will also be asked to complete several questionnaires pertaining to their moods and emotions. This session pays $20.00 an hour as well.

Contact
Catherine
Phone: 734-647-6249
Email: jlabfbstudy@umich.edu

Deadline for Enrollment: OPEN


Mothers with Depression Needed

Are you a mother with a daughter who is 9-14 years old? Have you had episodes of depression during your daughter's lifetime?

If so, you may be eligible to participate in a study of how moms and their daughters think and process emotional information.

The study takes place in the Psychology Department at Stanford University. You and your daughter would participate in interviews, fill out questionnaires, do computer tasks, have discussions with each other, and possibly be eligible for a brain scan. Involvement in the study requires a time-commitment of 3-10 hours over the course of one to three visits. We will schedule the sessions around your availability (daytime, evenings, or weekends are all fine).

Eligible pairs receive $40/hour for their time.

To be eligible for this study:

  • you must have a daughter between the ages of 9 and 14
  • you must have had episodes of depression during your daughter's lifetime
  • you must be a US citizen or hold a Green Card
  • you must read and speak English fluently
  • you should have no immediate plans to leave the Bay Area

If you would like to receive more information about this study, please email mood@psych.stanford.edu or call (650) 723-0804 to reach the study coordinator, Hannah Burley. Please refer to study #101. For general information about participant rights, contact 1-866-680-2906.

Your performance in all study-related activities, including requests for information will be kept completely confidential.

Deadline for enrollment: OPEN


Sleep and Memory

Sleep and Memory Study

  • Depressed participants needed
  • Males and females over the age of 18
  • No history of head injury causing unconsciousness
  • Able to spend 2 to 4 nights in the lab and keep a fixed sleep schedule
  • Willing to complete interview, questionnaires, and computer tasks
  • Monetary compensation of $75 per lab night

Contact
Adrienne McHenry
248-719-3887
amchenry@umich.edu


Depression Research Study

Feeling overwhelmed? sad? depressed? You may be suffering from depression.
Doctors at the University of California Los Angeles are researching a new technology to predict antidepressant effectiveness. Qualifying participants, ages 18-75, will receive antidepressants, study-related exams, tests and clinical consultations - at no cost. Also, monetary compensation may be provided. We conduct numerous studies on depression and enrollment is ongoing.

Contact
Lab of Brain, Behavior, and Pharmacology
310-825-3351
rohitm@brain.ucla.edu
http://www.brain.ucla.edu/

Deadline: Open


Depression Research Study (Southern California)

A Placebo-Controlled, Add-On (“Natural Supplement”) Study of MSI-195 (S-Adenosyl-L-Methionine, SAMe) For Patients With Major Depressive Disorder (MDD) Who Have Had An Inadequate Response to Current Antidepressant Therapy

The purpose of this study is to evaluate the safety and effectiveness of MSI-195 (SAMe) as an add-on treatment to an ongoing antidepressant medication. Qualified participants must be between 21 and 70 years of age and diagnosed with Depression. The duration of study participation is approximately two-to-three months, with up to six clinic visits and three telephone visits. Study-related care is provided at no cost to participants and compensation for travel is available. 

Pharmacology Research Institute (PRI) has been conducting research studies since 1975. Our offices are located in Orange County, Long Beach/Los Alamitos and Encino/San Fernando Valley. Please feel free to contact us or visit our website for more information. 

Contact
Mellissa M. Henry, R.N., M.S.N., N.P.
(888) 774-4673 or (714) 827-3667
mhenry@priresearch.com
www.priresearch.com

Deadline: Open


Deep brain stimulation for TRD

This study, conducted by Dr. Helen Mayberg, is looking a deep brain stimulation for the treatment of patients with treatment resistant depression. We are currently recruiting patients with bipolar type II depression and unipolar depression. For more information please contact us or visit our clinical trials website at: http://clinicaltrials.gov/ct2/show/NCT00367003?term=deep+brain+stimulation+for+depression&rank=6

Contact
Megan Filkowski
dbs@emory.edu
(404)727-9228
http://clinicaltrials.gov

Deadline: Open