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Healthy Lifestyles for Bipolar Disorder

Study acronym: HL
StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Site contact updatedv8
  2. Re-verified, no change to tracked fieldsv7
  3. Eligibility criteria expanded, about 21 wordsv6
  4. Eligibility criteria expanded, about 36 wordsv5
  5. Trial status: Not Yet Recruiting to Recruitingv4 Show 4 more changesShow less
    • Primary completion date: Jan 31, 2028 to Dec 28, 2028
    • Study completion date: Jan 31, 2029 to Feb 28, 2029
    • Start date changed from estimate of May 31, 2024 to Jun 5, 2024
    • Site details revised
Show 2 earlier versionsHide 2 earlier versions
  1. Study description revised
    • Eligibility criteria expanded, about 1 word
    v3
  2. Start date: Jan 31, 2024 to May 31, 2024v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this clinical trial is to compare the effects of two different healthy lifestyles on outcomes for those with bipolar disorder. The goals are to understand the acceptability of time-restricted eating and the mediterranean diet for those who are already receiving medication treatment for bipolar disorder, and to consider how these two food plans predict changes in manic symptoms, depressive symptoms, and Quality of Life. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow one of the two food plans for eight weeks. The investigators will measure symptoms and Quality of Life at baseline and during and after the food plan.
Trial Details
NCT Number NCT06188754
Lead Sponsor University of California, Berkeley
Collaborators: University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Salk Institute for Biological Studies, Wellcome Trust
Conditions
(from sponsor)		 Time Restricted Eating, Diet, Mediterranean
Related terms Bipolar Disorder, Intermittent Fasting
Enrollment 300 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov