Bipolar Disorder (BD)TREBDNCT07211217
Time Restricted Eating (TRE) in Bipolar Disorder
A study testing Time Restricted Eating in people with Bipolar Disorder (BD) and Bipolar Disorder Depression, run by Massachusetts General Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Bipolar Disorder (BD), Bipolar Disorder Depression, Overweight (BMI > 30)
- What is being tested?
- Time Restricted Eating
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Sep 2026to 30 Sep 2027
- 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
- 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
Who cannot join
- Dietary factors:
- Diagnosis, or strong clinical suspicion, of eating disorders, including but not limited to, anorexia nervosa, bulimia nervosa, binge eating disorder (as assessed with the Quick SCID)
- Concurrent dietary intervention or modification unrelated to study procedures
- Psychiatric factors:
- Severe depression (i.e., PHQ-9>20)
- Experiencing manic symptoms (i.e., ASRM < 6)23
Show all 22Show fewer
- Active suicidal ideation (i.e., PHQ-9, item 9 >2)
- Current alcohol/substance use disorder (as assessed with the Quick SCID)
- Medical factors:
- Use of weight loss medications or supplements
- Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months
- Previous weight loss surgery
- Malignancy within past 2 years
- Major surgery within past 3 months
- Medical instability considered to interfere with study procedures
- Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas)
- Undergoing treatment for cancer
- Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake.
- Lifestyle and other factors:
- Work or social schedules that would impede ability to adhere to study protocol
- Adherence factors:
- Ability to adhere to study procedures
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
Massachusetts General Hospital
Boston, Massachusetts, 02114
Giuliana Chau, 617-643-9923, gchau1@mgh.harvard.edu
About this study
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.
Read the detailed description
The overall goal of this study is to examine the effects of TRE on weight loss and secondary health outcomes in individuals with BD,. A secondary goal is to determine whether these effects are mediated by improvements in circadian rhythms.
Using an 8-week trial of 8-hour TRE compared to a wait list control group, the study will test the following specific aims:
- Examine the effect TRE on weight loss
- if compared to wait list control, individuals assigned to TRE will have greater improvement in waist circumference, depression, anxiety, cognition, sleep and daily functioning.
- if a change in circadian timing will significantly mediate the degree of improvement in body weight with TRE.
Our sample will be representative of the target population, or adults with bipolar disorder who are currently obese and depressed. The study interventions will be offered via telehealth to reduce barriers to access (e.g., childcare, time, parking/transportation costs, less time out of work).
Participants will have a study visit at the start (week 0), midway through (week 4), at the end of the 8-week intervention (week 8), and at a 3-month follow-up (week 20). Study visits will occur after 7 days of monitoring their food intake on Meallogger. To accommodate for scheduling conflicts that may arise, these visits can occur within +3 days of their scheduled dates, if necessary. Study procedures conducted during and surrounding these visits are the same for Weeks 0, 8 and 20.
To recognize participants for the time and effort involved in completing all study procedures.
- Being tested
- Time Restricted Eating
- Keywords
- Time Restricted Eating
- Medical subject headings
- Bipolar Disorder, Overweight, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Time Restricted EatingOther
See arms description
| Study group | Role | What they receive |
|---|---|---|
| Time Restrictive Eating Condition | Active 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). Receives: Other: Time Restricted Eating |
| Waitlist Condition | No intervention | Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weight Loss
Body weight will be collected in the fasted state using a digital scale (lbs)
Measured: Week 0, Week 8, Week 20
Secondary outcomes (8)
Patient Health Questionnaire-9 (PHQ-9)
It is a 9-item self-report questionnaire that is widely used to assess depression symptom severity. A PHQ-9 score ≥10 has a sensitivity of 88% and a specificity of 88% for major depression. PHQ-9 scores of 5, 10, 15, and 20 represented mild, moderate, moderately severe, and severe depression, respectively.
Measured: Week 0, Week 4, Week 8, Week 20
Generalized Anxiety Disorder scale (GAD-7)
The Generalized Anxiety Disorder Assessment (GAD-7) is a seven-item questionnaire that is used to measure or assess the severity of generalized anxiety disorder (GAD). The GAD-7 has good reliability, criterion, construct, factorial, and procedural validity. The raw score ranges from 0 to 21. Increasing scores are associated with multiple domains of functional impairment. Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
Measured: Week 0, Week 4, Week 8 and Week 20
Pittsburgh Sleep Quality Index (PSQI)
Change in sleep quality as measure by the Pittsburgh Sleep Quality Index (PSQI) global score. PSQI global score range is 0-21 with higher scores indicating more sleep disturbance. The Pittsburgh Sleep Quality Index (PSQI) is a widely used self-report questionnaire that assesses sleep quality over a one-month time interval. Nineteen individual items generate seven "component" scores: subjective sleep quality, sleep latency, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleeping medication, and daytime dysfunction. A global PSQI score greater than 5 yielded a diagnostic sensitivity of 89.6% and specificity of 86.5% in distinguishing good and poor sleepers.
Measured: Week 0, Week 4, Week 8, Week 20
Cognitive complaints in bipolar disorder rating assessment (COBRA)
The Cognitive Complaints in Bipolar Disorder Rating Assessment (COBRA) evaluates cognitive impairments which were perceived in daily living. It consists of 16-items using a 4-point Likert scale as follows for each item: 0 = never, 1 = sometimes, 2 = often, and 3 = always. The COBRA had a one-factor structure and showed high internal consistency.
Measured: Week 0, Week 4, Week 8, Week 20
Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a
Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a is an 8-item self report questionnaire assess subjective cognitive difficulties regarding a patient's concentration, memory, language, mental acuity, as well as perceived changes in cognitive functioning. It has strong internal consistency reliability, supporting its use as a reliable measure of subjective cognitive functioning. This measure has seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, social functioning, sleep disturbance). The scale includes four items per domain, each scored from 1 to 5. The scale also includes one question at the end about pain intensity, which is scored from 0 to 10. The possible score ranges from 8 to 40. Higher scores indicate poorer outcomes.
Measured: Week 0, Week 4, Week 8, Week 20
World Health Organization Disability Assessment Scale (WHODAS 2.0)
The adult self-administered version of the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) is a 36-item measure that assesses disability in adults age 18 years and older. It assesses disability across six domains, including understanding and communicating, getting around, self-care, getting along with people, life activities (i.e., household, work, and/or school activities), and participation in society. Each item is rated on a 5-point scale from 0 (none) to 4 (extreme or cannot do), with higher scores indicating greater disability. The total score is calculated by summing the item scores, which can then be converted into a standardized score ranging from 0 to 100, with higher scores indicating greater disability.
Measured: Week 0, Week 4, Week 8, Week 20
The Altman Self-Rating Mania Scale (ASRM)
The Altman Self-Rating Mania Scale (ASRM) is a five-item scale that assesses mood, self-confidence, sleep disturbance, speech, and activity level over a week. The ASRM at a screening cutoff score of 5.5 has shown an optimal combination of sensitivity and specificity (85% and 86%, respectively). The ASRM score range from 5 to 25 with higher scores indicating greater severity of manic symptoms
Measured: Week 0, Week 4, Week 8, Week 20
Changes in waist size
Measurements of the waist
Measured: Week 0, 8, and 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2025
- Study start1 Sep 2026
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Waitlist Control Group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Responsible party
- Principal investigator, Louisa Grandin Sylvia, Massachusetts General Hospital
- Investigators
- Louisa G. Sylvia, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07211217
- Sponsor's protocol ID
- 2025P002114
- Acronym
- TREBD
- Status last verified
- Oct 2026
- First submitted
- 26 Sep 2025
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Time Restricted Eating (TRE) in Bipolar Disorder
- ClinicalTrials.gov ID
- NCT07211217
- Acronym / sponsor ID
- TREBD / 2025P002114
- Keywords
- Time Restricted Eating
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Collaborators
- Brigham and Women's Hospital
- Study start
- 1 Sep 2026 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2027 (estimated)
- First posted
- 7 Oct 2025 (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.
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.
Detailed description
The overall goal of this study is to examine the effects of TRE on weight loss and secondary health outcomes in individuals with BD,. A secondary goal is to determine whether these effects are mediated by improvements in circadian rhythms.
Using an 8-week trial of 8-hour TRE compared to a wait list control group, the study will test the following specific aims:
- Examine the effect TRE on weight loss
- if compared to wait list control, individuals assigned to TRE will have greater improvement in waist circumference, depression, anxiety, cognition, sleep and daily functioning.
- if a change in circadian timing will significantly mediate the degree of improvement in body weight with TRE.
Our sample will be representative of the target population, or adults with bipolar disorder who are currently obese and depressed. The study interventions will be offered via telehealth to reduce barriers to access (e.g., childcare, time, parking/transportation costs, less time out of work).
Participants will have a study visit at the start (week 0), midway through (week 4), at the end of the 8-week intervention (week 8), and at a 3-month follow-up (week 20). Study visits will occur after 7 days of monitoring their food intake on Meallogger. To accommodate for scheduling conflicts that may arise, these visits can occur within +3 days of their scheduled dates, if necessary. Study procedures conducted during and surrounding these visits are the same for Weeks 0, 8 and 20.
To recognize participants for the time and effort involved in completing all study procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Waitlist Control Group
| Arm | Type | Receives |
|---|---|---|
| Time Restrictive Eating Condition | Active comparator | Other: Time Restricted EatingTRE 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 Condition | No intervention | –Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (22 listed)
- Dietary factors:
- Psychiatric factors:
- Medical factors:
- Lifestyle and other factors:
- Adherence factors:
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 EatingSee arms description | Other | Time Restrictive Eating Condition |
Primary outcome
Weight Loss
Time frame: Week 0, Week 8, Week 20
Body weight will be collected in the fasted state using a digital scale (lbs)
8 secondary outcomes
Patient Health Questionnaire-9 (PHQ-9)
Time frame: Week 0, Week 4, Week 8, Week 20
Generalized Anxiety Disorder scale (GAD-7)
Time frame: Week 0, Week 4, Week 8 and Week 20
Pittsburgh Sleep Quality Index (PSQI)
Time frame: Week 0, Week 4, Week 8, Week 20
Cognitive complaints in bipolar disorder rating assessment (COBRA)
Time frame: Week 0, Week 4, Week 8, Week 20
Patient-reported Outcome Measurement Information System (PROMIS) Cognitive Function Short Form 8a
Time frame: Week 0, Week 4, Week 8, Week 20
World Health Organization Disability Assessment Scale (WHODAS 2.0)
Time frame: Week 0, Week 4, Week 8, Week 20
The Altman Self-Rating Mania Scale (ASRM)
Time frame: Week 0, Week 4, Week 8, Week 20
Changes in waist size
Time frame: Week 0, 8, and 20
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 7 Oct 2026.
Related trials for Bipolar Disorder (BD)
Enrolling by invitation
Incentives and Long-Acting Injectable Adherence After Involuntary Hospitalization
Schizophrenia Disorder, Schizoaffective Disorder
Not yet recruiting
Evaluating the PolarUs App in People With Bipolar Disorder
Bipolar Disorder (BD), Quality of Life (QOL)
RecruitingPhase 3
Pramipexole vs Placebo Treatment in Bipolar Disorder With Anhedonic Depression
Bipolar Disorder (BD)
Recruiting
French Minds Cohort: a French Longitudinal and Multimodal Cohort of Patients With Major Mood Disorders, Psychotic Disorders, Autism Spectrum Disorders, and Healthy Controls
Schizophrenia / Schizoaffective Disorder, First Episode Psychosis (FEP)
Not yet recruitingObservational study
BAROMETRE : Study on the Prognosis and Course of Individuals With Bipolar Spectrum Disorder
Bipolar Disorder (BD)
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.
Louisa G. Sylvia, PhD principal investigator
Massachusetts General Hospital
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 in people with Bipolar Disorder (BD) and Bipolar Disorder Depression, run by Massachusetts General Hospital 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 5 inclusion and 22 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 7 Oct 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 Giuliana M Chau (16176439923, gchau1@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Weight Loss (time frame: Week 0, Week 8, Week 20). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Oct 2026.