The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Lumateperone 42 mg.
- Who it may be relevant to
- Registry conditions: Bipolar Depression Depressed Phase, Obesity & Overweight. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
Overview
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]
- Inflammatory Markers [Time frame: 6 weeks]
Eligibility criteria
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).
- BMI > 30
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Massachusetts General Hospital — Boston
Identifiers
NCT: NCT07699445 · 2026P001267