NCT07699445 · Massachusetts General Hospital
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
What this study is about
This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.
View original scientific description
This research study examines how a medication called lumateperone may affect mood symptoms, and inflammation in adults with bipolar disorder over approximately 6 weeks. An MRI scan to calculate biological age of the brain will also be obtained at the start of the study.
Interventions
DRUG
Lumateperone 42 mg
Lumateperone 42 mg orally daily
Primary outcome measures
MADRS
Time frame: 6 week
Montgomery Asperg Depression Rating Scale
Inflammatory Markers
Time frame: 6 weeks
Tissue Necrosis factor alpha, C-reactive protein, Interleukins 1 beta, 6, 18
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Aged 18 to 65 years.
- Meets DSM-V criteria for Bipolar I Disorder -Depressed without psychosis as confirmed by a semi-structured clinical interview that includes the Mini International Neuropsychiatric Interview.
- Current episode at least 4 weeks in duration but not longer than 12 months.
- Depression score \> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
- Capable of providing informed consent.
Exclusion criteria
- Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
- Young Mania Rating Scale score \>12.
- Meets DSM-V criteria for rapid cycling.
- Co-Morbid psychiatric illness, other than generalized anxiety and specific phobias, that in the opinion of the investigator is severe enough that it would likely interfere with the interpretation of changes in the subject's mood state.
- Meets DSM-V criteria for an active substance use disorder within the past month.
- Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).
- Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).
- Significant risk of harm to others as assessed by clinical interview.
- Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.
- Current or prior treatment with lumateperone.
- Moderate or severe hepatic impairment.
- Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
- History of seizure disorder.
- Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.
- Dementia-related psychosis.
- Known hypersensitivity or allergy to lumateperone or any of its components.
Where
- Boston, Massachusetts
Collaborators
Johnson & Johnson K.K. Medical Company
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 11, 2026 · Source of record for eligibility and locations