An interventional study of Time Restricted Eating in Bipolar Disorder (BD), Bipolar Disorder Depression and Overweight (BMI > 30), sponsored by Massachusetts General Hospital. Recruiting at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-11-10.
Sponsored by Massachusetts General Hospital · Not applicable, Interventional, and Treatment
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.
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:
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.
1,683 studies on the registry are indexed under Bipolar Disorder; 266 are open to participants now.
This study's planned enrollment of 40 is below the median of 64 across 1,279 interventional studies indexed under Bipolar Disorder.
Browse Bipolar Disorder studies →Massachusetts General Hospital is the lead sponsor of 2,586 studies on the registry; 447 are open to participants now.
Of its 222 completed or terminated interventional studies of FDA-regulated products, 168 (76%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Dietary factors:
Psychiatric factors:
Medical factors:
Lifestyle and other factors:
a. Work or social schedules that would impede ability to adhere to study protocol
Adherence factors:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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).
Other: Time Restricted Eating
Participants assigned to the wait list condition will have the option of receiving the TRE intervention after 20 weeks.
See arms description
Weight Loss
Body weight will be collected in the fasted state using a digital scale (lbs)
Time frame: Week 0, Week 8, Week 20
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Week 0, Week 4, Week 8, Week 20
Changes in waist size
Measurements of the waist
Time frame: Week 0, 8, and 20
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Massachusetts General Hospital →