Investigating circadian therapies for managing bipolar mania
Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
This study is testing whether wearing blue-blocking glasses and following a time-restricted eating plan can help people with bipolar disorder manage their manic episodes better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 16 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06504342 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to explore the feasibility and effectiveness of two novel therapies, blue-blocking glasses and time-restricted eating, for patients experiencing manic episodes of bipolar disorder. The study will involve a randomized, parallel three-group design, assessing the impact of these interventions on manic symptoms and sleep-wake cycles. Researchers will also conduct qualitative interviews to identify barriers and support needs for patients undergoing these therapies. The long-term goal is to inform a larger adaptive factorial study based on the findings from this pilot.
Who should consider this trial
Good fit: Ideal candidates are individuals over 16 years old with DSM-5-defined manic symptoms and a Young Mania Rating Scale score of 20 or higher.
Not a fit: Patients with a history of eating disorders, severe brain injuries, or other significant medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide safer, non-pharmacological treatment options for patients with bipolar mania.
How similar studies have performed: While there is limited research specifically targeting these therapies for mania, similar chronotherapy approaches have shown promise in other contexts.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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.
Where this trial is running
Ottawa, Ontario
- Ottawa Hospital Research Insitute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Jess G Fiedorowicz, MD, PHD — Ottawa Hospital Research Institute
- Study coordinator: Jess G Fiedorowicz, MD, PHD
- Email: jfiedorowicz@toh.ca
- Phone: +1 613-798-5555
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.