Healthy Lifestyles in Bipolar Disorder: Bay Area Study

This study is looking at how a lifestyle change called time-restricted eating might help people with bipolar disorder. Time-restricted eating means limiting your food intake to 10 hours per day. You could join if you are 18 to 65 years old, have bipolar I or bipolar II disorder, and are already taking medication for it. The researchers want to see if this eating pattern can lead to fewer symptoms of mania and depression, and improve your overall quality of life. The study is currently unclear about its recruitment status.

Study design
This is a single-arm study, meaning all 150 participants will receive the same intervention. It is designed to examine the effects of time-restricted eating.
What's involved
You would complete daily measures of eating, sleep, and mood for two weeks, then follow time-restricted eating for eight weeks. You would also have measures taken at the middle and end of the intervention, and three months later.
Compensation
Not stated in the trial record.
Follow-up
You would be followed for three months after the 8-week intervention period.

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NCT06555406

Healthy Lifestyles in Bipolar Disorder: Bay Area Study

Recruiting
NAAges 18–65InterventionalTreatment
University of California, Berkeley
~150 participants
Updated 2026-01-14 on ClinicalTrials.gov
What's tested:Time-restricted eating for 8 weeks

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mania
Measured over Lower YMRS at the end of intervention (10 weeks) as compared to baseline
+2 more outcomes measured
Bipolar Disorder
Time Restricted Eating
1 sites across 1 states
California1
  • Sheri L Johnson, PhD · PRINCIPAL_INVESTIGATOR · University of California, Berkeley

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Eligibility criteria

Inclusion

Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, bipolar disorder Not otherwise specified or bipolar disorder due to another medical condition) assessed by the Diagnostic Interview for Anxiety, Mood, and Obsessive-compulsive and Related Neuropsychiatric Disorders \[DIAMOND\])
current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type) concerns indicated by endorsement of at least some sleep or circadian-related impairment across the screening self-reports or interview
Living in an English-speaking country (and one that the researchers have expertise in research procedures and diet)
Has been speaking English for at least 10 years, speaks English in the home, or certifies that they are able to understand English well for the study and demonstrates this during the screening interview.
Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)
Mood-stabilizing medication regimens stable for at least one month
\< 5 kg weight change in the past 3 months
Currently eating ≥ 12 hours per day at least twice per week
Able to operate the camera function and respond to web-based surveys by phone (loaner phones will be provided as needed)
Not engaged in current shift work or have other responsibilities such as providing care that would chronically disrupt their sleep (i.e., \> 3 h between 22:00 and 05:00 h for at least 1 day/week)
Able to complete 7 days of dietary logs adequately (e.g., at least 2 entries per day, covering at least a 5-hour eating window) during the baseline period
Able to complete screening and baseline questionnaires adequately (e.g., not failing more than 1 attention check item with instructed responding; responding to standard multiple-choice items in a mean of \< 2 seconds per item). Where individuals respond to more than 14 items in a row with the same response, their answers will be manually reviewed for possible invalidity.

Exclusion

Current episode of depression, hypomania or mania, or psychosis (assessed by the DIAMOND), Participants with acute mood disorder episodes will be encouraged to seek treatment and to consider the study when symptoms have remitted.
Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire (EDE-QS) scores above clinical concern thresholds for eating disorders, or DIAMOND interview of symptoms during adulthood)
Past 3-month alcohol use disorder or substance use disorder (assessed by DIAMOND)
Active suicidal ideation coupled with plan, intent or attempt history as assessed by Columbia Suicide Severity Rating Scale
Conditions that would interfere with ability to take part in the intervention, including pregnancy, breastfeeding, uncorrected hypo or hyperthyroidism, gastrointestinal conditions impairing nutrient absorption
Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
Cognitive deficits as noted during the initial interview or as indicated by low performance on the Orientation Memory Concentration Test- Short Version (weighted score \< 20)
  • ManiaLower YMRS at the end of intervention (10 weeks) as compared to baseline

    Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)

  • DepressionLower MADRS at the end of intervention (10 weeks) as compared to baseline

    Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)

  • Self-rated Quality of Life (QOL)Scores at 1.5-months post-intervention (16 weeks) as compared to baseline

    self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) (minimum: 12, maximum: 60, higher scores reflect better QOL)