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.
Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression (RAPID KOR) (Philadelphia, PA)
This study is looking at the efficacy, rapidity, safety, and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them.
This study will involve 10 visits to the clinical site over approximately 1.5 months. There will be a screening visit (7-28 days may pass between the screening visit and the first treatment visit), a baseline/treatment visit (first day of study drug treatment), followed by 5 consecutive days of treatment visits. Follow-up visits will occur 6, 13, and 20 days after first receiving study drug.
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.
Deadline for Enrollment: 3/31/2016
A Randomized, Double-blind, Multicenter, Active-Controlled Study of Intranasal Esketamine Plus an Oral Antidepressant for Relapse Prevention in Treatment-resistant Depression (Chicago, IL)
This is a randomized, double-blind (neither the researchers nor the participant know what treatment the participants is receiving), active-controlled, multicenter (more than 1 study site) study in participants with Treatment Resistant Depression to assess the efficacy of intranasal esketamine plus an oral antidepressant compared with an oral antidepressant (active comparator) plus intranasal placebo in delaying relapse of depressive symptoms. Participants will enter the study either directly (direct-entry participants) or after completing the double-blind induction phase of one of the short-term efficacy studies (ESKETINTRD3001 or ESKETINTRD3002) (transferred-entry participants). The study will consist of 5 phases: Screening/Prospective Observational Phase (4-7 weeks) for direct-entry participants only, Open-label Induction Phase (4-weeks) for direct-entry participants only, Optimization Phase (12-weeks; open-label for direct-entry participants and double-blind for transferred-entry participants), Maintenance Phase (variable duration; double-blind for all participants) and Follow-up Phase (2-weeks). Direct-entry participants must be taking an oral antidepressant treatment with nonresponse at the start of the screening/prospective observational phase and will continue this treatment for the duration of this phase to confirm nonresponse prospectively. This antidepressant treatment will be discontinued prior to the Open-label Induction Phase. Direct-entry participants will receive intranasal esketamine (flexibly dosed as 56 milligrams [mg] or 84 mg) twice weekly for 4 weeks. In addition, each participants will be assigned to receive 1 of 4 oral antidepressant medications from 2 different classes of antidepressant treatments, a Selective Serotonin Reuptake Inhibitor (SSRI) (escitalopram or sertraline) or a Serotonin and Norepinephrine Reuptake Inhibitor (SNRI) (duloxetine or venlafaxine extended release [XR]), initiated on Day 1 and continued through the treatment phases (Induction, Optimization, and Maintenance). Direct-entry participants who are responders at the end of the open-label induction phase and transferred-entry participants from the short term efficacy studies will enter the Optimization Phase. In the Optimization Phase the frequency of intranasal treatment sessions will be reduced from that in the induction phase (twice weekly) to weekly for the first 4 weeks of this phase, and then individualized to either once weekly or once every other week based on the severity of depressive symptoms. Participants who sustain the response at the end of the optimization phase will continue into the Maintenance Phase, where those treated with intranasal esketamine and an oral antidepressant will be randomly assigned to either continue intranasal esketamine (same dose) and the same oral antidepressant or to continue with the same oral antidepressant but switch to intranasal placebo, and those treated with intranasal placebo and an oral antidepressant will continue to receive intranasal placebo and the same antidepressant. Participants will be primarily evaluated for relapse of depressive symptoms by the Montgomery-Asberg Depression Rating Scale (MADRS) total score. Participants safety will be monitored throughout the study.
What will I do?
Participants will be restricted from receiving any other treatments while participating in the study. All participants will receive the study drug at some point in the study. After the optimization phase of the study 50% of subjects will get the study drug, 50% will get placebo.
Deadline for Enrollment: 03/30/2016
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.
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.
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.
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.
Deadline for Enrollment: December 31, 2018
A Phase 3, Double-Blind, Placebo-Controlled Study of an Investigatonal Drug as Adjunctive Therapy in Major Depressive Disorder (Chicago, IL)
An 18- to 19-week augmentation study for adults who are 18-65 years of age. Eligible participants must meet criteria for major depressive disorder and have failed to respond to adequate trials of one or two antidepressants in the past. Those who meet criteria and enter the study will participate in an 8-week open-label antidepressant treatment phase followed by an 8-week double-blind treatment period. All subjects will remain on the antidepressant he or she was taking when entering the study.
There are restrictions, including other treatments for depression as well as treatments that may be taken for other conditions but are prohibited during the study. Some participants will receive a placebo added to their ongoing antidepressant treatment instead of the investigational drug. All participants, however, will remain on the base antidepressant medication throughout the study.
Deadline for Enrollment: December 31, 2016
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.
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).
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
Exclusion criteria for participants with MDD or BD
Inclusion criteria for control subjects
Exclusion criteria for control subjects
Deadline for Enrollment: 2018
PET Imaging of mGluR5 with Drug Challenge (New Haven, CT)
We are looking for people who have major depressive disorder to participation in a brain-imaging study to examine certain receptors in the brain that may be related to depression, and the effect of a drug called ketamine on those receptors.
To be eligible you must:
If you choose to participate, you will have 2 fMRI and 3 PET scans, and receive an administration of ketamine. You will be paid up to $990. Study participation duration is 1–2 months
Deadline for Enrollment: March 2016
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.
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:
If you would like to receive more information about this study, please email firstname.lastname@example.org 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
Depression Research Study
Feeling overwhelmed? sad? depressed? You may be suffering from depression.
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.
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
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