No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 65
Sex
Any
Trial phase
Phase 4
Study type
Interventional
Purpose
Treatment
Participants needed
25 (estimated)
Sponsor
Massachusetts General Hospital · Other
Who this trial is looking for
This trial is looking for adults aged 18 to 65 with bipolar depression and obesity. Participants will take a medication called lumateperone for about 6 weeks and undergo a brain scan at the start of the study.
Are You a Good Fit for This Trial?
Rules you outSeizure disorderDementia-related psychosisHepatic impairmentSevere cardiovascular disease
You may be able to join if
I am between 18 and 65 years old.
I have been diagnosed with Bipolar I Disorder - Depressed phase.
My current depressive episode has lasted at least 4 weeks.
I have a depression score above 20.
My BMI is over 30.
I am capable of providing informed consent.
You may not be able to join if
I have schizophrenia or significant mood-incongruent psychotic symptoms.
I have a Young Mania Rating Scale score above 12.
I have rapid cycling in my bipolar disorder.
I have a severe psychiatric illness that affects my mood.
I have had a substance use disorder in the last month.
I have an active medical condition affecting my mood.
I am at significant risk of suicide or self-harm.
I am currently pregnant or unwilling to use birth control.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Aged 18 to 65 years.
2. 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.
3. Current episode at least 4 weeks in duration but not longe…
Inclusion Criteria:
1. Aged 18 to 65 years.
2. 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.
3. Current episode at least 4 weeks in duration but not longer than 12 months.
4. Depression score \> 20 on the Montgomery Asberg Depression Rating Scale (MADRS).
5. BMI \> 30
6. Capable of providing informed consent.
Exclusion Criteria:
1. Meets DSM-V criteria for Schizophrenia, Schizoaffective disorder, or has significant mood-incongruent psychotic symptoms.
2. Young Mania Rating Scale score \>12.
3. Meets DSM-V criteria for rapid cycling.
4. 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.
5. Meets DSM-V criteria for an active substance use disorder within the past month.
6. Active medical condition that in the opinion of the investigator would contribute to the subject's depressed mood (e.g. hypothyroidism).
7. Significant risk of suicide or self -harm as assessed by clinical interview and the Columbia Suicide Severity Rating Scale (C-SSRS).
8. Significant risk of harm to others as assessed by clinical interview.
9. Pregnancy, or, in women of child-bearing potential, an unwillingness to use an accepted method of birth control for the duration of the study.
10. Current or prior treatment with lumateperone.
11. Moderate or severe hepatic impairment.
12. Current treatment with strong or moderate CYP3A4 inhibitors or CYP3A4 inducers.
13. History of seizure disorder.
14. Significant cardiovascular or cerebrovascular disease that, in the opinion of the investigator, would increase study risk.
15. Dementia-related psychosis.
16. Known hypersensitivity or allergy to lumateperone or any of its components.
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