Research Studies: Bipolar Disorder
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 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.
A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC-34712) in Adolescents with Schizophrenia or Other Related Psychiatric Disorders (Baltimore, MD)
This research study is being conducted by Kennedy Krieger Institute/centers across the United States to determine whether brexpiprazole is safe and effective in adolescents with schizophrenia or a related psychiatric disorder.
If eligible, the participant will visit the Kennedy Krieger Institute up to 9 times over a period of 102 days. Each visit will take between 30 minutes and 2 hours and will include psychological and behavioral testing, medical history, physical examination, blood draws, HIV testing, vital sign, ECG, urine drug screen, and pregnancy testing for females.
For each completed visit, participants will receive a reimbursement of $75.00 for their time and travel expenses. Please ask a study team member for specifics. All testing is done free of charge.
Please call 443-923-3850 for questions about specific co-ocurring treatments.
Rapid Antidepressant Effects of Ketamine in Bipolar 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
- Male or female subjects, 18 to 55 years of age.
- Age of onset less than 40 years of age.
- Female subjects of childbearing age must be using a medically accepted method of contraception.
- Each subject must have a level of understanding sufficient to agree to all required tests and examinations and sign an informed consent document.
- 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).
- 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.
- 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.
- Current major depressive episode of at least 4 weeks duration.
- In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
Exclusion criteria for participants with MDD or BD
- 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. 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.
- Female subjects who are either pregnant or nursing.
- Serious, unstable illnesses including hepatic, renal, gastroenterologic, respiratory, cardiovascular (including ischemic heart disease), endocrinologic, neurologic, immunologic, or hematologic disease.
- 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 clinical hypothyroidism or hyperthyroidism.
- Subjects with one or more seizures without a clear and resolved etiology.
- Treatment with a reversible MAOI within two weeks prior to Phase I of Substudy 4.
- Treatment with fluoxetine within five weeks or aripiprazole within three weeks before Phase I of Substudy 4.
- Treatment with any other concomitant medication (Appendix 4) 14 days prior to Phase I of Substudy 4.
- Presence of metallic (ferromagnetic) implants (e.g, heart pacemaker, aneurysm clip).
- 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
- Age 18-55 years.
- Written informed consent completed.
- In women of childbearing age, a negative pregnancy test within 24 hours of MRI.
Exclusion criteria for control subjects
- Current or past Axis I diagnosis
- Presence of metallic (ferromagnetic) implants (e.g., heart pacemaker, aneurysm clips).
- Presence of medical illness likely to alter brain morphology and/or physiology (e.g., hypertension, diabetes) even if controlled by medications.
- Treatment with any of the exclusionary medications detailed in Appendix 4 14 days prior to Phase 1 of the Substudy 4.
- Current or past alcohol or substance abuse or dependence diagnosis (except for nicotine or caffeine).
- Presence of psychiatric disorders in first-degree relatives.
- Female subjects who are either pregnant or nursing.
Libby Jolkovsky, M.S.
Examination of Glutamate and mGluR5 in Psychiatric Disorders
(New Haven, CT)
We are looking for people with bipolar disorder to participate in a brain imaging study.
To be eligible you must:
-Be between the ages of 18-65
-Have a diagnosis of bipolar disorder
-Not use drugs or drink a lot of alcohol
If you choose to participate you will receive brain scans to measure certain receptors that may be related to bipolar disorder. You will be paid up to $415. Study participation duration is 1–2 months
Deadline for Enrollment: March 2016
Potential Use of Brain Network Activation (BNA) Analysis Using Evoked Response Potentials to Diagnose Unipolar Major Depression and Bipolar I Depression and Assess Response to Treatment (Skokie, IL)
Help researchers find the biological indicator of depression and bipolar disorder by participating in the Brain Network Activation study (i.e., EEG)! If you are currently battling depression or bipolar disorder, you may qualify to participate in the study.
This study lasts 6-8 weeks and involves a non-invasive treatment. If you aren't currently receiving medication, you will receive one that is already FDA-approved. The study consists of approximately three visits with an EEG conducted at each. Upon the end of the study, study completers may be eligible for up to 90 days of free treatment.
Rae Watkins, PsyD
Phone: (847) 679-8000
Deadline for Enrollment: January 5, 2016
Pathophysiology and Treatment of Bipolar Disorder as assessed by In Vivo Imaging (Stony Brook, NY)
The purpose of this study is to identify changes in the brain chemistry of patients with bipolar disorder, and to measure differences in brain chemistry before and after treatment for bipolar depression. The treatments being studied are lithium and lamotrigine (Lamictal).
Deadline for enrollment: 7/10/16
Pharmacokinetics of Lamotrigine in Pregnant and Postpartum Women with Bipolar Disorder (Chicago, IL)
Background: Lamictal (lamotrigine) is FDA approved and commonly used to treat Bipolar Disorder. Because Bipolar Disorder frequently affects women during their reproductive years, it is important for us to understand how the dose of Lamictal should be modified for women who are pregnant. By participating in this study, you can help optimize the quality of care for women with Bipolar Disorder.
Goal: To understand the need for changes in dosage level of Lamictal for pregnant women with a history of Bipolar Disorder
Eligibility: Women ages 18-45; Diagnosis of Bipolar Disorder; Planning to become pregnant, or in the first or second trimester of pregnancy; Taking daily dose of Lamictal (lamotrigine) for mood symptom management What you will do: At your initial visit, you will complete a full psychiatric evaluation with Dr. Clark at no cost to you. At each subsequent visit, you will stay overnight in the clinical research unit and complete assessments to monitor your mood, as well as blood draws to monitor your lamotrigine levels.
Compensation: Reimbursement for on-site parking or public transportation; Financial compensation between $75-125 for every study visit you complete; Medical consultation with Dr. Crystal Clark about the best treatment for you throughout pregnancy; Gifts for you and your baby; Careful monitoring of your mood symptoms throughout pregnancy at no cost to you Principal Investigator: Crystal T. Clark, MD, MSc
Deadline for Enrollment: 09/30/2015
A Clinical Trial of Mobile Telephone based Assessment and Intervention for Persons with Bipolar Disorder or Schizophrenia (La Jolla (San Diego), CA)
The purpose of this study is to evaluate the effectiveness of a mobile real-time cognitive behavioral intervention for serious mental illness (SMI) and to identify the facilitators, barriers, and costs of implementation. We would like to determine whether the addition of a mobile phone monitoring software program to a brief behavioral intervention for bipolar disorder or schizophrenia improves symptoms arising from the disorders. We aim to address symptoms, improve socialization, medication adherence, and relapse prevention.
- Diagnosis of Bipolar Disorder or Schizophrenia
- No CBT in the past 5 years
- Currently on a stable dose of medication
Participants cannot receive any cognitive behavior therapy while in the study.
There are three different groups. One is treatment as usual, one is active control, and one is treatment. There is an equal change of being randomized in each group.
Deadline for Enrollment:
NIH Research Studies: Bipolar Disorder & Severe Irritability Symptoms (Bethesda, Maryland)
How do the brain and the symptoms change as children grow up?
(Enrolling Nationwide, Eligible Participants Ages 6-17)
Researchers will describe over time the moods and behavior of children use specialized testing and brain imaging to learn about specific brain changes associated with bipolar disorder or severe irritability in children. Studies involve 1-5 outpatient visits, with follow up visits as the child grows up. All clinical evaluations, research procedures, and outpatient visits are free of cost. Children and parents are compensated for participation. Travel and lodging expenses are paid by NIMH.
Participants must have a bipolar diagnosis, or have symptoms of severe irritability. Irritability symptoms include: difficulty handling frustration (severe temper tantrums and rages) and "hyper" behavior (distractible, hyperactive, trouble sleeping).
Call for more information and eligibility criteria.
NIMH Irritable Kids
301-496-8381, TTY: 1-866-411-1010
Deadline for Enrollment:
Developing Brain Function in Adolescent (Chicago, IL)
Developing Brain Function in Adolescent Bipolar Disorder
This study focuses on the developmental changes in cognitive and affective neural circuitry functioning in adolescents with Pediatric Bipolar Disorder
(PBD) over a three-year period. We will characterize the course of illness and associated neurocognitive function in patients with PBD as well as determine the association between brain function and behavior.
During the study, participants will complete a baseline diagnostic interview, clinical assessments, neurocognitive and neuropsychological tests, and a functional MRI brain scan. Participants will also have the option to draw blood for pharmacogenetic analyses. Testing will be repeated once a year for three years after the baseline visit, four visits total.
Deadline for Enrollment: Ongoing