Status:
NOT_YET_RECRUITING
Time Restricted Eating (TRE) in Bipolar Disorder
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Brigham and Women's Hospital
Conditions:
Bipolar Disorder (BD)
Bipolar Disorder Depression
Eligibility:
All Genders
18-65 years
Phase:
NA
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 ...
Detailed Description
The overall goal of this study is to examine the effects of TRE on weight loss and secondary health outcomes in individuals with BD,. A secondary goal is to determine whether these effects are mediate...
Eligibility Criteria
Inclusion
- 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
- 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
- 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)
- 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.
- Lifestyle and other factors:
- a. Work or social schedules that would impede ability to adhere to study protocol
- Adherence factors:
- Ability to adhere to study procedures
Key Trial Info
Start Date :
January 1 2026
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 30 2027
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT07211217
Start Date
January 1 2026
End Date
September 30 2027
Last Update
December 8 2025
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