Bipolar Disorder Clinical Studies in Boston Area
This is a list of ongoing clinical trials regarding bipolar disorder at at Harvard affiliated hospitals. If you would like to list your groups here please contact us at info@brain.harvard.edu.
BD Studies at the Dauten Center for Bipolar Innovation
The Dauten Family Center for Bipolar Treatment Innovation is located at Mass. General Hospital. You can learn more about their mission and research here: https://dautenbipolarcenter.org/
COMPARE: Comparing Behavior Therapy and Yoga for Treating Depression Among Adults
Our goal is to compare two treatments for depression: one is a gentle, relaxation and mindfulness-based form of yoga; the other is a talk therapy called behavioral activation that focuses on motivating people to get out and do things that are meaningful to them. We also hope to identify why one or the other of these treatments works better for some people in reducing their depressive symptoms than for others. We plan to compare real-time, online yoga classes to a first-line treatment for depression, namely, behavioral therapy (also provided remotely via video- or telehealth). We hope that the results of this study will inform providers, patients, payors, and advocates as to whether yoga is as effective as another first-line treatment for depression, therefore building the case that yoga should be supported financially by health insurance. 
Recruitment ends December 2025. If interested, contact our research coordinator:
Giuliana Chau, gchau1@mgh.harvard.edu, 617-643-9923
BezafibrateTreatment for Bipolar Depression: A Proof of Concept Study
We are studying the effectiveness of Bezafibrate, a drug that lowers fat, in treating bipolar depression. Bipolar disorder is among the top causes of disability worldwide and negative health outcomes remain highly prevalent. Only 20% to 30% of bipolar patients achieve remission from a mood episode and even then, remain stable for two years. New drug development for bipolar disorder, and especially bipolar depression, has generally stalled in the past decade, with few new methods of treatment and no treatments developed specifically for bipolar disorder. Investigating whether Bezafibrate can be an effective drug treatment for bipolar depression can help improve patient outcomes.
Recruitment is ongoing. If interested, contact our research coordinator:
Naia Wolfenzon, nwolfenzon@mgh.harvard.edu, 617-726-1366 
Xenon Inhalation Therapy for Major Depressive Disorder and Bipolar Disorder
We are doing this research study to find out if using xenon could be helpful for people with Major Depression and Bipolar Depression who have not responded to the usual medications or combination of medications and who are currently depressed. Xenon is a drug that calms and relaxes the body. Xenon is not approved by the U.S. Food and Drug Administration (FDA). This means that xenon can only be used in research studies. Xenon is a colorless, odorless gas used as a general anesthetic in Europe. Xenon has been used safely in adults and in children. This research study will compare xenon to placebo. The placebo being used is called nitrogen, which is similarly colorless and odorless. Air is composed largely of nitrogen. Placebos are used in research studies to see if the results are due to the study drug or due to other reasons. You will have two treatment sessions, in one of them we will administer xenon and in one of them we will administer placebo. You will not know which one you are administered at the visit.
Recruitment is ongoing. If interested, contact our research coordinator:
Yousif Alsaadi, yalsaadi@mgb.org, 617-726-0997
Sequential Multiple Assignment Randomized Trial for Bipolar Depression (SMART-BD)
Currently, there is little to no information about which bipolar depression medications work best for which patients. The Sequential Multiple Assignment Randomized Trial for Bipolar Depression (SMART-BD) study aims to change that by is comparing the four most commonly prescribed medications for bipolar depression. These treatments include three medications approved by the FDA for bipolar depression (quetiapine, lurasidone, and cariprazine). The other medication (aripiprazole/escitalopram) is a commonly prescribed combination that is not FDA approved for bipolar depression, but each one of them is approved by the FDA for the treatment of major depressive disorder. Our study will contribute important information about the effectiveness of this combination that many people are currently taking.
Recruitment is ongoing. If interested, contact our research coordinator:
Giuliana Chau, gchau1@mgh.harvard.edu, 617-643-9923
FITT-BD Clinic
FITT-BD is an outpatient clinic at the Dauten Family Center for Bipolar Treatment Innovation at Massachusetts General Hospital. It’s designed to help people with bipolar disorder gain the skills and understanding they need to independently manage their condition. At the FITT-BD clinic, we strive to treat every patient holistically, considering such things as exercise and sleep, as well as actively engaging the support of family and friends. All of our providers have expertise in treating people with bipolar disorder and are involved in research to identify more effective treatments for this condition.
If interested, please call us at 617-643-9185, or email us at fitt-bd@mgh.harvard.edu
Neuroinflammation and Executive Function in Bipolar Disorder: A PET-fMRI Study
Executive dysfunction — a term used to describe difficulties reaching goals, including (but not limited to) poor time management and issues with organization and problem-solving — is a very common and disabling symptom of bipolar disorders. However, even though it is common, scientists are still unclear as to what part(s) of the brain are involved in executive dysfunction. It is possible that inflammation in the brain contributes. The goal of this study is to identify whether inflammation in the brain is related to executive dysfunction in bipolar disorder. We will use brain imaging techniques (PET and fMRI) to do this. 
Recruitment is paused until January 2026. If interested, contact our research coordinator:
Naia Wolfenzon, nwolfenzon@mgh.harvard.edu, 617-726-1366
Microvascular Markers of Cognitive Dysfunction in Bipolar Disorder
We are studying how we can use pictures of the eye to better understand brain function and heart health in adults with and without bipolar disorder. Cognitive deficits are common in individuals with bipolar disorder, but we don’t know what is causing them. The vessels in the eyes are very similar to those in the brain and by looking at pictures of the retina, the structure in the back of the eyeball that tells the brain what we are seeing, we can get an idea about what the vessels in the brain look like. This non-invasive procedure may give us insight into brain function in bipolar disorder and and help us make better treatments and methods of prevention.
Recruitment is paused until January 2026. If interested, contact our research coordinator:
Bridget Hall, bhall18@mgb.org, 617-643-0049
 
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