Healthy Lifestyles in Bipolar Disorder: Bay Area Study
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorUniversity of California, Berkeley
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Time-restricted eating for 8 weeks
Behaviorallimiting food intake to 10 hours per day
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: Time Restricted Eating (TRE) for 8 weeksExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Mania
Young Mania Rating Scale (YMRS) total scores (minimum: 0, maximum: 60, high scores reflect higher manic symptom severity)
Time frame
Lower YMRS at the end of intervention (10 weeks) as compared to baseline2
Depression
Montgomery Asberg Depression Scale (MADRS) total scores (minimum: 0, maximum: 60, higher scores reflect higher depressive symptom severity)
Time frame
Lower MADRS at the end of intervention (10 weeks) as compared to baseline3
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)
Time frame
Scores at 1.5-months post-intervention (16 weeks) as compared to baselineSecondary outcomes
1
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)
Time frame
YMRS and LIFE scores will be lower at 3 months post-intervention as compared to baseline2
Depression at follow-up
MADRS scores (described above) across follow-up
Time frame
MADRS scores will be lower at 3 months post-intervention as compared to baseline3
Self-rated mania
Patient Health Questionnaire (PMQ) Mania scores (minimum: 0, maximum: 27, higher scores reflect more severe 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 baseline4
Self-rated depression
Patient Health Questionnaire (PHQ) Depression scores (minimum: 0, maximum: 27, higher scores reflect more severe depression)
Time frame
post-intervention (10 weeks) and at 1.5 and 3 months follow-ups post-intervention, as compared to baselineSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of California, Berkeley
Lead sponsor
Salk Institute for Biological Studies
Collaborator
University College, London
Collaborator
Swinburne University of Technology
Collaborator
Deakin University
Collaborator
University of British Columbia
Collaborator
Wellcome Trust
Collaborator
Source ClinicalTrials.gov