Time Restricted Eating (TRE) in Bipolar Disorder
Eligible age
18–65 yrs
Accepts
All genders
Locations
1 state
Healthy volunteers
No
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About this study
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.
Sponsor: Massachusetts General Hospital
You may qualify if…
- ✓ 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
You may not qualify if…
- ✕ 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)
Where it's recruiting
Boston
Source: ClinicalTrials.gov · NCT07211217 · last updated 2026-10-07