NCT07211217 Time Restricted Eating (TRE) in Bipolar Disorder
| NCT ID | NCT07211217 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Massachusetts General Hospital |
| Condition | Bipolar Disorder (BD) |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2026-06-15 |
| Primary Completion | 2026-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2026-06-15 with a primary completion date of 2026-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
This is a randomized controlled trial investigating the effects of an 8-TRE intervention compared to a wait list (control) on metabolic health and body composition in people diagnosed with BD and who are currently obese and at least mildly depressed. Following a 1-week baseline assessment, participants will be randomized to either a TRE or the wait list (1-to-1 ratio) for 8 weeks. At baseline, Week 8 (post treatment), and Week 20 (follow-up), investigators will assess daily eating patterns for one week, followed by collection of fasting lipids, body weight and vital signs. At Week 4 (i.e., mid-treatment), the investigators will assess self-reported outcomes only. Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.
Eligibility Criteria
Inclusion Criteria: * Adults (aged 18-65 years) * Diagnosed with bipolar disorder (i.e., subtype Bipolar I or II as assessed with the Quick SCID)21 * Currently experiencing depression (i.e., PHQ-9 ≥ 10)22 * Currently overweight (i.e., Body mass index (BMI) \> 30 kg/m2) * Provides Informed Consent Exclusion Criteria: 1. Dietary factors: 1. Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID) 2. Concurrent dietary intervention or modification unrelated to study procedures 2. Psychiatric factors: 1. Severe depression (i.e., PHQ-9\>20) 2. Experiencing manic symptoms (i.e., ASRM \< 6)23 3. Active suicidal ideation (i.e., PHQ-9, item 9 \>2) 4. Current alcohol/substance use disorder (as assessed with the Quick SCID) 3. Medical factors: 1. Use of weight loss medications or supplements 2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months 3. Previous weight loss surgery 4. Malignancy within past 2 years 5. Major surgery within past 3 months 6. Medical instability considered to interfere with study procedures 7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas) 8. Undergoing treatment for cancer 9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake. 4. Lifestyle and other factors: a. Work or social schedules that would impede ability to adhere to study protocol 5. Adherence factors: 1. Ability to adhere to study procedures
Contact & Investigator
Louisa G. Sylvia, PhD
PRINCIPAL INVESTIGATOR
Massachusetts General Hospital
Frequently Asked Questions
Who can join the NCT07211217 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Bipolar Disorder (BD). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07211217 currently recruiting?
Yes, NCT07211217 is actively recruiting participants. Contact the research team at gchau1@mgh.harvard.edu for enrollment information.
Where is the NCT07211217 trial being conducted?
This trial is being conducted at Boston, United States.
Who is sponsoring the NCT07211217 clinical trial?
NCT07211217 is sponsored by Massachusetts General Hospital. The principal investigator is Louisa G. Sylvia, PhD at Massachusetts General Hospital. The trial plans to enroll 40 participants.
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