Bipolar Disorder (BPD) Clinical Trials

Find Bipolar Disorder (BPD) Clinical Trials Near You

Time Restricted Eating (TRE) in Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: f
View:

• 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

Locations
United States
Massachusetts
Massachusetts General Hospital
RECRUITING
Boston
Contact Information
Primary
Giuliana M Chau
gchau1@mgh.harvard.edu
16176439923
Time Frame
Start Date: 2026-06-15
Estimated Completion Date: 2027-09-30
Participants
Target number of participants: 40
Treatments
Active_comparator: Time Restrictive Eating Condition
TRE is a dietary intervention where participants eat all of their food within a specific 8-hour eating window, for example eating only between 10am and 6pm. Participants will not be asked to change what they eat, only when to eat. Participants will keep a daily Food Timing Log to record the time of the first and last food and drink that they consume each day. The study will ask participants to continue to do this daily throughout the study (\~8 weeks).
No_intervention: Waitlist Condition
Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital
Leads: Massachusetts General Hospital

This content was sourced from clinicaltrials.gov