Bipolar Depression Depressed Phase study: Lumateperone
Official title The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
ClinicalTrials.gov ID: NCT07699445
What this study is testing
What is Lumateperone 42 mg?
Lumateperone 42 mg is an investigational oral medication being studied for bipolar depression (depressed phase).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study wants to see if the drug changes mood symptoms and inflammation in people with bipolar depression and overweight or obesity.
- Who it's for
- Adults who have bipolar depression and are overweight or obese.
- What's involved
- Participants will take the medication for about 6 weeks, have mood and inflammation tests, and get an MRI scan at the start.
- Time commitment
- The study lasts about 6 weeks and includes regular visits for medication, tests, and the initial MRI.
- Phase 4: studies an already-approved treatment
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 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...
- 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
You likely can't join if
- 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...
- 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).
See the full eligibility 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.
- 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...
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Boston, Massachusetts, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.