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SYNCED - SYNChronized Eating in Bipolar Depression Study

RecruitingNAAges 18 Years - 55 YearsAllUniversity of Ottawa
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In plain words

What the trial is, and whether it could suit you

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 "clock") disruption, which can involve changes in sleep-wake cycles, frequently occurs in BD. Both depression and mania are accompanied by circadian disruption. These disruptions are hypothesized to lead to mood worsening, metabolic dysfunction and inflammation. If circadian dysfunction plays a significant role in the symptoms and trajectory of BD, then treatment approaches that target these functions may lead to better outcomes. One such approach is dietary interventions. Time restricted eating (TRE) is a dietary tool that restricts the eating to an 8-12 hour window, without changing diet quality or caloric intake. Studies involving time restricted eating have been done in other conditions

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: 1. Be 18-55 years old 2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5ยฎ Disorders, QuickSCID-5. 3. Have depression symptoms as indicated by a score of โ‰ฅ12 on MADRS and โ‰ค12 on YMRS. 4. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\* 5. Participants must be able to speak, read, write and understand English or French. 6. Be willing and able to provide informed consent. Exclusion Criteria: 1. Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5ยฎ Disorders, QuickSCID-5. 2. Have any unstable or inadequately treated neurological and medical conditions. 3. Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications. 5\. Be pregnant or lactating. 6. Currently taking any stimulant medications. 7. Be participating in any other diet or weight management program for the duration of the trial. 8\. Have any contraindication to fasting as judged by the assessing clinician. 9. 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). 10\. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.
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What it tests

  • Time restricted eating
  • Eating ad libitum with nutritional counselling
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Where

1 site
Ottawa Hospital Research Institute
Ottawa, Canada
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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