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Eating within a 8-Hour window may boost mood and shrink waistlines in bipolar disorder

NCT ID NCT07211217

Symptom relief Sponsor: Massachusetts General Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether eating only during an 8-hour window each day (time-restricted eating) can help people with bipolar disorder who are overweight and depressed lose weight and improve their mood. Forty adults will be randomly assigned to either follow this eating pattern for 8 weeks or join a waitlist. Researchers will track weight, blood fats, and depression symptoms over 20 weeks.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

Sep 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Exclusion Criteria: 1. Dietary factors: 1. 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) 2. Concurrent dietary intervention or modification unrelated to study procedures 2. Psychiatric factors: 1. Severe depression (i.e., PHQ-9\>20) 2. Experiencing manic symptoms (i.e., ASRM \< 6)23 3. Active suicidal ideation (i.e., PHQ-9, item 9 \>2) 4. Current alcohol/substance use disorder (as assessed with the Quick SCID) 3. Medical factors: 1. Use of weight loss medications or supplements 2. Use of medications that may cause weight loss or gain, unless body weight and medication usage remained stable for at least 6 months 3. Previous weight loss surgery 4. Malignancy within past 2 years 5. Major surgery within past 3 months 6. Medical instability considered to interfere with study procedures 7. Use of medications that have the potential to cause hypoglycemia (e.g., insulin, sulfonylureas) 8. Undergoing treatment for cancer 9. Use of medications for which time restricted eating would interfere with recommended timing of medication ingestion with food intake. 4. Lifestyle and other factors: a. Work or social schedules that would impede ability to adhere to study protocol 5. Adherence factors: 1. Ability to adhere to study procedures

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Conditions

The condition(s) this trial relates to.

bipolar depression bipolar disorder Intermittent Fasting Overweight

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Bipolar disorder (BD) Bipolar disorder depression Overweight (bmi > 30)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Massachusetts General Hospital

    RECRUITING

    Boston, Massachusetts, 02114, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.