Bipolar DisorderNCT06555406
Healthy Lifestyles in Bipolar Disorder: Bay Area Study
A study testing Time-restricted eating for 8 weeks in people with Bipolar Disorder and Time Restricted Eating, run by University of California, Berkeley at 1 site in United States.
Trial summary
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder, Time Restricted Eating
- What is being tested?
- Time-restricted eating for 8 weeks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2024to 1 Feb 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 12Show fewer
- < 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.
Who cannot join
- 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
- Medications contraindicated for fasting: clozapine, glucose-lowering medications, diabetes-related injections, medications requiring food early morning or late evening, corticosteroids; Glucagon-like peptide-1 (GLP-1) agonists will not be an exclusion criteria if weight stabilized
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California Berkeley
Berkeley, California, 94720-2010
Nandini Rajgopal, BS, (510) 519-4305, calmprogram@berkeley.edu
Sheri L Johnson, PhD, (510) 519-4305, calmprogram@berkeley.edu
About this study
Official title: Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
Read the detailed description
This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.
- Conditions
- Bipolar Disorder, Time Restricted Eating
- Being tested
- Time-restricted eating for 8 weeks
- Keywords
- sleep, insomnia, circadian rhythms
- Medical subject headings
- Bipolar Disorder, Intermittent Fasting, Sleep Initiation and Maintenance Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time-restricted eating for 8 weeksBehavioural
Also called intermittent fasting
limiting food intake to 10 hours per day
| Study group | Role | What they receive |
|---|---|---|
| Time Restricted Eating (TRE) for 8 weeks | Experimental | Participants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window > 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline. Receives: Behavioral: Time-restricted eating for 8 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mania
Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)
Measured: Lower YMRS at the end of intervention (10 weeks) as compared to baseline
Depression
Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)
Measured: Lower MADRS at the end of intervention (10 weeks) as compared to baseline
Self-rated Quality of Life (QOL)
self-rated Brief Quality of Life in Bipolar Disorder (QoL.BD) (minimum: 12, maximum: 60, higher scores reflect better QOL)
Measured: Scores at 1.5-months post-intervention (16 weeks) as compared to baseline
Secondary outcomes (7)
Mania at follow-up
YMRS (described above) and Longitudinal Interval Follow-up Evaluation (LIFE; minimum 0, maximum 6) scores across follow-up (higher scores reflect more severe symptoms)
Measured: YMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline
Depression at follow-up
MADRS scores (described above) across follow-up
Measured: MADRS scores will be lower at 3 months post-intervention as compared to baseline
Self-rated mania
Patient Health Questionnaire (PMQ) Mania scores (minimum: 0, maximum: 27, higher scores reflect more severe mania)
Measured: Lower PMQ scores at post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Self-rated depression
Patient Health Questionnaire (PHQ) Depression scores (minimum: 0, maximum: 27, higher scores reflect more severe depression)
Measured: post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Acceptability
Participant self-ratings of the acceptability of the intervention: The primary index of acceptability will be the percentage of individuals who endorse that they agree or strongly agree that they would recommend the food plan to a friend. This single item has been used in previous trials of bipolar disorder. Higher agreement will be considered a positive outcome.
Measured: immediately post-treatment (10 weeks after enrollment)
Weekly change in mania severity
Longitudinal Interval Follow-up Evaluation (LIFE) weekly mania scores post-treatment as compared to those at baseline. The investigators will administer the LIFE interview at 6 months after study entry, and interviewers will record a mania severity rating for each week, to cover the time from the end of intervention until 6-month follow-up. Better outcomes would be reflected in lower LIFE scores post-treatment.
Measured: Weekly scores from the end of the intervention through 3 months post-intervention
Daily emotional lability as assessed using ecological momentary assessment
Mean square of successive difference of negative affect scores within derived from the ecological momentary assessments at 7 weeks post-baseline as compared to baseline. Participants will be asked to complete negative affect ratings 5 times per day for 7 days, at the baseline and mid-point of treatment. The investigators will calculate scores to examine the degree of negative affect variability for each day, and then take the average across 7 days at baseline and at treatment mid-point. Better outcomes would be indicated by lower scores.
Measured: 7 weeks post-study entry as compared to baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2024
- Study start22 Nov 2024
- Primary completion1 Feb 2029 (estimated)
- Study completion1 Feb 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- All participants will be assigned to time-restricted eating. Adherence levels are expected to predict change in outcomes and proposed mechanisms. Key hypothesized mechanisms include salivary dim-light melatonin onset and buccal swab assessment of circadian clock genes to assess the amplitude of clock gene expression.
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- Salk Institute for Biological Studies, University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Wellcome Trust
- Responsible party
- Sponsor
- Investigators
- Sheri L Johnson, PhD, Principal investigator, University of California, Berkeley
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06555406
- Sponsor's protocol ID
- TRE_Study2
- Status last verified
- Jan 2026
- First submitted
- 12 Aug 2024
- Last updated
- 14 Jan 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Measures, data, and analysis scripts will be shared through Open Science Foundation.
Publications
Johnson SL, Murray G, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Bower CD, Berle EF, Joyner K, Villanueva R, Michalak EE, Kriegsfeld LJ. A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 Oct 21;24(1):711. doi: 10.1186/s12888-024-06157-5.
PubMed 39434066
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time-restricted Eating as an Adjunctive Intervention for Bipolar Disorder
- ClinicalTrials.gov ID
- NCT06555406
- Acronym / sponsor ID
- TRE_Study2
- Conditions
- Bipolar Disorder, Time Restricted Eating
- Keywords
- sleep, insomnia, circadian rhythms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- Salk Institute for Biological Studies, University College, London, Swinburne University of Technology, Deakin University, University of British Columbia, Wellcome Trust
- Study start
- 22 Nov 2024 (actual)
- Primary completion
- 1 Feb 2029 (estimated)
- Study completion
- 1 Feb 2029 (estimated)
- First posted
- 15 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to understand how level of adherence with time-restricted eating (TRE) predicts change in diurnal rhythms (as measured using the amplitude of diurnal peripheral clock gene expression), and how those changes predict lower mania and depressive symptoms, and downstream improvements in quality of life. The effects of diurnal amplitude of clock gene expression is expected to remain significant when controlling for change in glucose tolerance and inflammation. Participants will be enrolled who are already receiving medication treatment for bipolar disorder. Participants will complete daily measures of eating, sleep and mood for two weeks, and then will be assigned to follow TRE for eight weeks. Symptoms and Quality of Life will be measured at baseline and during and after the food plan.
Detailed description
This is a single-arm trial to examine the effects of time-restricted eating on change in diurnal rhythms, manic and depressive symptoms, and quality of life. In time-restricted eating (TRE), participants will be asked to limit their food intake to a period of 10 hours per day. TRE will be an addition to standard medication approaches in bipolar disorder. Participants who are receiving medical treatment for bipolar disorder and who report at least some sleep or circadian problems will complete baseline measures and then will be asked to follow TRE for 8 weeks, and then will complete measures of symptoms, Quality of Life, and possible treatment mechanisms at the mid-point of treatment, the end of treatment, and at 3 months after the intervention. If successful, this work will help understand key mechanisms through which TRE provides benefits for those with BD.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- All participants will be assigned to time-restricted eating. Adherence levels are expected to predict change in outcomes and proposed mechanisms. Key hypothesized mechanisms include salivary dim-light melatonin onset and buccal swab assessment of circadian clock genes to assess the amplitude of clock gene expression.
| Arm | Type | Receives |
|---|---|---|
| Time Restricted Eating (TRE) for 8 weeks | Experimental | Behavioral: Time-restricted eating for 8 weeksParticipants will receive an intro to TRE and then throughout 8 weeks they will receive brief online psychoeducation several times per week with optional weekly coaching sessions. TRE involves restricting the window of eating to 10 hours/ day, most typically by avoiding eating in the first 1-2 hours after awakening and in the 2-4 before sleep. Those with an eating window > 14 hours will be asked to restrict their eating to 12 hours in the first week, then 10 hours in week 2. To select the period, investigators will ask Ss to review baseline logs to consider sleep, eating, family meals and social commitment schedules, and any special energy demands, such as exercise. During the eating window, no restrictions are placed on the type or quantity of food consumed. The investigators will instruct participants to follow their habitual diet within their 10-hour eating window and to aim to consume the same number of calories per day as they did at baseline. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Time-restricted eating for 8 weeksAlso: intermittent fastinglimiting food intake to 10 hours per day | Behavioural | Time Restricted Eating (TRE) for 8 weeks |
Primary outcome
Mania
Time frame: Lower 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)
Depression
Time frame: Lower 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)
Time frame: 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)
7 secondary outcomes
Mania at follow-up
Time frame: YMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline
Depression at follow-up
Time frame: MADRS scores will be lower at 3 months post-intervention as compared to baseline
Self-rated mania
Time frame: Lower PMQ scores at post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Self-rated depression
Time frame: post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baseline
Acceptability
Time frame: immediately post-treatment (10 weeks after enrollment)
Weekly change in mania severity
Time frame: Weekly scores from the end of the intervention through 3 months post-intervention
Daily emotional lability as assessed using ecological momentary assessment
Time frame: 7 weeks post-study entry as compared to baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2026.
- Derived from this study: PubMed 39434066Johnson SL, Murray G, Manoogian ENC, Mason L, Allen JD, Berk M, Panda S, Rajgopal NA, Gibson JC, Bower CD, Berle EF, Joyner K, Villanueva R, Michalak EE, Kriegsfeld LJ. A pre-post trial to examine biological mechanisms of the effects of time-restricted eating on symptoms and quality of life in bipolar disorder. BMC Psychiatry. 2024 Oct 21;24(1):711. doi: 10.1186/s12888-024-06157-5.
- Individual participant dataSharing planned: Yes. Measures, data, and analysis scripts will be shared through Open Science Foundation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sheri L Johnson, PhD principal investigator
University of California, Berkeley
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Time-restricted eating for 8 weeks in people with Bipolar Disorder and Time Restricted Eating, run by University of California, Berkeley at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sheri L Johnson, PhD ((510) 519-4305, calmprogram@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mania (time frame: Lower YMRS at the end of intervention (10 weeks) as compared to baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06555406, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2026.