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TREBDNCT07211217

Time Restricted Eating (TRE) in Bipolar Disorder

StatusRecruiting
PhaseNot applicable
Primary completion (estimated)

At risk: Primary completion moved 10 months later.

See at-risk trials from Massachusetts General Hospital

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Record History

All 7 versions: 7 with changes below. See every version on ClinicalTrials.gov ↗

  1. Primary completion pushed from Sep 30, 2026 to Jul 30, 2027
  2. Eligibility criteria expanded, about 16 words Show 4 more changesShow less
    • Start date changed from estimate of Jun 15, 2026 to Sep 1, 2026
    • Secondary endpoints: details revised at 7 of 8 entries
    • Collaborators: details revised at 1 of 1 entry
    • Study description expanded, about 3 words
  3. Recruitment opened
    • Study sites: 0 to 1
    • Start date: Jun 1, 2026 to Jun 15, 2026
    v5
  4. Start date: Mar 24, 2026 to Jun 1, 2026v4
  5. Start date: Jan 1, 2026 to Mar 24, 2026v3
  6. Start date: Oct 1, 2025 to Jan 1, 2026v2
  7. Study First Submitted
  • Notable: the plan changed

Endpoints

Primary

Weight Loss
Timeframe: Week 0, Week 8, Week 20

Secondary (8)

Patient Health Questionnaire-9 (PHQ-9)
Generalized Anxiety Disorder scale (GAD-7)
Pittsburgh Sleep Quality Index (PSQI)
Cognitive complaints in bipolar disorder rating assessment (COBRA)
Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a
Show 3 moreShow less
World Health Organization Disability Assessment Scale (WHODAS 2.0)
The Altman Self-Rating Mania Scale (ASRM)
Changes in waist size

Arms and interventions

Time Restrictive Eating ConditionActive comparator

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).

Waitlist ConditionNo intervention

Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.

Other: Time Restricted Eating

Sites

1 site in 1 country

  • Massachusetts General HospitalBoston, Massachusetts, United States