Status:
RECRUITING
Clocks in Sync - Circadian Rhythm and Bipolar Mania
Lead Sponsor:
Ottawa Hospital Research Institute
Conditions:
Bipolar Disorder
Mania
Eligibility:
All Genders
16+ years
Phase:
NA
Brief Summary
The sleep-wake cycle is severely disrupted during an episode of mania. Often mania is treated with medications that can come with significant side effects. Years of patient and family engagement with ...
Detailed Description
This pilot study will assess feasibility and preliminary data for a novel circadian intervention in a clinical population that has been understudied, patients dealing with manic episodes of bipolar di...
Eligibility Criteria
Inclusion
- Be over age 16
- Have DSM-5-defined manic symptoms that persist beyond the physiological effects of a substance and a YMRS≥20
- Be willing to have investigators obtain information from the treatment team and electronic medical record
- Participants must be able to read and understand English or French.
- Be willing and able to provide informed consent.
Exclusion
- Have a history of eating disorders.
- Have a diagnosis of moderate to severe traumatic brain injury with residual or long-term effects, parenchymal brain surgery or stroke
- Have a neurocognitive disorder
- Take hypoglycemia-inducing medications
- Be pregnant/lactating women
- Have a diagnosis of sleep apnea
- 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 :
September 17 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT06504342
Start Date
September 17 2024
End Date
October 1 2025
Last Update
January 17 2025
Active Locations (1)
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1
Ottawa Hospital Research Insitute
Ottawa, Ontario, Canada, K1Y 4E9