Status:
NOT_YET_RECRUITING
SYNCED - SYNChronized Eating in Bipolar Depression Study
Lead Sponsor:
University of Ottawa
Collaborating Sponsors:
Ottawa Hospital Research Institute
Conditions:
Bipolar Depression
Bipolar I Disorder
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment. Circadian rhythm (your internal day/night...
Detailed Description
Given the lack of studies evaluating time restricted eating (TRE), this pilot study aims to examine the feasibility and acceptability of TRE as a prelude to a future multi-centre randomized controlled...
Eligibility Criteria
Inclusion
- Be 18-55 years old
- Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) Research Version (SCID-RV)
- Have mild to moderate depression symptoms as indicated by a score of ≥12 and ≤30 on MADRS and ≤12 on Young Mania Rating Scale (YMRS).
- Be willing to use email for study activities
- Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\*
- Be able and willing to use email and a smartphone application for the duration of the trial
- Participants must be able to speak, read, write and understand English or French.
- Be willing and able to provide informed consent.
Exclusion
- Have clinically significant suicidal ideation, defined as ≥ 4 on MADRS suicide item
- Have any catatonic symptoms, eating disorders, borderline personality disorder and substance use disorders as measured by the Structured Clinical Interview for the DSM-5 Research Version (SCID-RV)
- Have any unstable or inadequately treated neurological and medical conditions
- Have had prior bariatric surgery
- Be taking hypoglycemia inducing medications
- Be pregnant or lactating
- Currently on stimulant medications
- Be participating in any other diet or weight management program for the duration of the trial.
- Have any contraindication to fasting as judged by the assessing clinician.
- Recently started taking a Canadian Network for Mood and Anxiety Treatments (CANMAT) recommended treatment18 for the management of acute bipolar depressive episode, but has not had a trial for a minimum of 6 weeks with adequate doses.
- Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
- Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.
Key Trial Info
Start Date :
April 15 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06560957
Start Date
April 15 2025
End Date
June 30 2026
Last Update
March 28 2025
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