Bipolar Depression Depressed PhasePhase 4NCT07699445
The Effects of Lumateperone on Obesity and Physiologic Aging and Their Association With Antidepressant Response in Bipolar Depression
A Phase 4 study testing Lumateperone 42 mg in people with Bipolar Depression Depressed Phase and Obesity & Overweight, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Depression Depressed Phase, Obesity & Overweight
- What is being tested?
- Lumateperone 42 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2026to 31 Jul 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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).
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Massachusetts General Hospital
Boston, Massachusetts, 02114
Michael E Henry, MD, 6176435750, mhenry14@mgh.harvard.edu
About this study
Official title: The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
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.
- Being tested
- Lumateperone 42 mg
- Keywords
- Bipolar disorder, Depression, obesity
- Medical subject headings
- Obesity, Overweight, Bipolar Disorder, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lumateperone 42 mgDrug
Lumateperone 42 mg orally daily
| Study group | Role | What they receive |
|---|---|---|
| Lumateperone treatment | Experimental | Lumateperone treatment for Bipolar type I depression Receives: Drug: Lumateperone 42 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
MADRS
Montgomery Asperg Depression Rating Scale
Measured: 6 week
Inflammatory Markers
Tissue Necrosis factor alpha, C-reactive protein, Interleukins 1 beta, 6, 18
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start9 Sep 2026
- Primary completion31 Jan 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Depression Depressed PhaseStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Subjects with bipolar disorder type I depressed phase with comorbid obesity will receive open label lumateperone. Baseline weight, serum markers of inflammation, and a structural MRI scan will be obtained pretreatment. Weight and serum markers of inflammation will be measured post treatment.
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Responsible party
- Principal investigator, Michael Henry, Massachusetts General Hospital
- Investigators
- Michael E Henry, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07699445
- Sponsor's protocol ID
- 2026P001267
- Status last verified
- Sep 2026
- First submitted
- 7 Jul 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Lumateperone on Obesity and Physiologic Aging and Their Correlation With Antidepressant Response in Bipolar Depression
- ClinicalTrials.gov ID
- NCT07699445
- Acronym / sponsor ID
- 2026P001267
- Keywords
- Bipolar disorder, Depression, obesity
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Johnson & Johnson K.K. Medical Company
- Study start
- 9 Sep 2026 (actual)
- Primary completion
- 31 Jan 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Subjects with bipolar disorder type I depressed phase with comorbid obesity will receive open label lumateperone. Baseline weight, serum markers of inflammation, and a structural MRI scan will be obtained pretreatment. Weight and serum markers of inflammation will be measured post treatment.
| Arm | Type | Receives |
|---|---|---|
| Lumateperone treatment | Experimental | Drug: Lumateperone 42 mgLumateperone treatment for Bipolar type I depression |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lumateperone 42 mgLumateperone 42 mg orally daily | Drug | Lumateperone treatment |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Michael E Henry, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lumateperone 42 mg in people with Bipolar Depression Depressed Phase and Obesity & Overweight, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Natalie Herbold, BS (6177248986, nherbold@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MADRS (time frame: 6 week). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.