The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years to 65 Years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Not stated
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 6 weeks
- Procedures mentioned: MRI scans
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Not stated
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study tests how lumateperone may affect mood and inflammation in adults with bipolar I depression and obesity over about 6 weeks. Inflammation is the body's response to injury or illness. An MRI scan at the start will estimate the brain's biological age.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are 18 to 65 years old.
- A clinical interview confirms bipolar I disorder with current depression and no psychosis, such as seeing or believing things that are not real.
- Your current depression has lasted at least 4 weeks but no more than 12 months.
- Your score is above 20 on the MADRS depression rating scale.
- Your body mass index (BMI), a measure based on height and weight, is above 30.
- You can understand the study and agree to take part.
Who can't join
- You have schizophrenia, schizoaffective disorder, serious psychosis symptoms that do not match your mood, or psychosis related to dementia.
- Your mania rating score is above 12, you have rapid cycling (frequent mood episodes), or another mental health condition could make mood changes hard to judge. General anxiety and specific phobias are allowed.
- You have had an active substance use disorder in the past month, or a medical condition that the study doctor thinks adds to your depression, such as an underactive thyroid.
- You have a serious risk of suicide, self-harm, or harming others.
- You are pregnant, or you could become pregnant and will not use an accepted form of birth control during the study.
- You take or have taken lumateperone, or you are allergic to it or any of its ingredients.
- You have moderate or severe liver problems, a history of seizures, or serious heart or brain blood vessel disease that the study doctor thinks raises your risk.
- You take medicines that strongly or moderately block CYP3A4, or medicines that increase its activity. CYP3A4 helps the body break down medicines.
Simplified for readability. The official criteria below are what the study team uses.
Official 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 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.
Study sites (1)
MA
- Massachusetts General Hospital · Boston, MA 02114Michael E Henry, MD · Study contact · 6176435750 · mhenry14@mgh.harvard.eduMore trials in Boston