Clinical trial for Bipolar Disorder
Official title Healthy Lifestyles in Bipolar Disorder: Bay Area Study
ClinicalTrials.gov ID: NCT06555406
What this study is testing
- What it's testing
- The study wants to see if sticking to a time‑restricted eating schedule changes the body’s daily rhythm genes and whether those changes reduce mania and depression symptoms and improve quality of life.
- Who it's for
- It is looking for adults who already take medication for bipolar disorder.
- What's involved
- Participants will record what they eat, sleep, and mood for two weeks, then follow a time‑restricted eating plan for eight weeks, with symptom and quality‑of‑life checks at the start, during, and after the plan.
- Time commitment
- The study lasts about ten weeks, with daily self‑reports for the first two weeks and an eight‑week eating plan, plus several check‑in visits for symptom and quality‑of‑life assessments.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Meets diagnostic criteria for bipolar I disorder or bipolar II disorder (but not cyclothymia, bipolar disorder Not otherwise specified or bipolar...
- current sleep (insomnia, hypersomnolence) or circadian sleep-wake (delayed phase, advanced phase, irregular sleep-wake, non-24-hour sleep-wake-type)...
- 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...
- Receiving medical care for bipolar disorder (referrals will be provided for those who would like to begin care)
You likely can't join if
- Current episode of depression, hypomania or mania, or psychosis (assessed by the DIAMOND), Participants with acute mood disorder episodes will be...
- Eating disorder diagnosis (by self-report of treatment or diagnosis at any point during their life, Short Eating Disorder Examination Questionnaire...
- 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...
- Conditions that would confound immune or other study measures, such as HIV, AIDS, lupus, or multiple sclerosis
See the full eligibility criteria
Who can 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...
- 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...
- 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
What rules you out
- 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...
- 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...
- 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
- 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)
The study team makes the final eligibility decision.
Where it is enrolling
- Berkeley, California, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Berkeley, California, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.