NCT07211217Recruiting
Time Restricted Eating (TRE) in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 7 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- First submitted
- 26 Sept 2025
- Start date
- 1 Sept 2026
- Primary completion date
- 30 Sept 2026
- Lead sponsor
- Massachusetts General Hospital
- Diseases
- Bipolar disorder
- NCT number
- NCT07211217
What you commit to
- Study type: Interventional
- Planned participants: 40
- From 1 Sept 2026 to the primary completion date, 30 Sept 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Dietary factors:
- 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)
- Concurrent dietary intervention or modification unrelated to study procedures
- Medical factors:
- Use of weight loss medications or supplements
- Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
- Previous weight loss surgery
- Malignancy within past 2 years
- Major surgery within past 3 months
- Medical instability considered to interfere with study procedures
- Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
- Undergoing treatment for cancer
- Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.
Other illness
- Psychiatric factors:
- Severe depression (i.e., PHQ-9\>20)
- Experiencing manic symptoms (i.e., ASRM \< 6)23
- Active suicidal ideation (i.e., PHQ-9, item 9 \>2)
- Current alcohol/substance use disorder (as assessed with the Quick SCID)
Other
- Lifestyle and other factors:
- Work or social schedules that would impede ability to adhere to study protocol
- Adherence factors:
- Ability to adhere to study procedures
Who the study is looking for
- 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
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Massachusetts General Hospital Coordinator of this site? Confirm its status | Boston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.