NCT06504342Completed
Clocks in Sync - Circadian Rhythm and Bipolar Mania
Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
Source: ClinicalTrials.gov · Last updated 18 Feb 2026
Brief summary (registry, in English)
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 this population have revealed great interest in therapies targeting the sleep-wake cycle. However, there is still a lack of studies to support using these treatments for mania. Patient partners are especially interested in two specific therapies for mania, blue-blocking glasses and time-restricted eating, because of their perceived feasibility and safety. This pilot study will formally investigate the feasibility and effectiveness of these therapies for participants with mania, an understudied population that faces many difficulties even after recovery. The pilot study will collect interviews to identify barriers and ways to better support patients with mania using the therapies. The study will also investigate how well these therapies can treat manic symptoms and restore sleep-wake cycles by tracking symptom rating scales and measuring activity levels. Results from this pilot will be used to direct a larger study that will use a state-of-the art design to test the effectiveness of both therapies alone and in combination.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 21 (actual)
- First submitted
- 25 Jun 2024
- Start date
- 17 Sept 2024
- Primary completion date
- 2 Oct 2025
- Lead sponsor
- Ottawa Hospital Research Institute
- Diseases
- Bipolar disorder
- NCT number
- NCT06504342
What you commit to
- Study type: Interventional
- Participants enrolled: 21
- From 17 Sept 2024 to the primary completion date, 2 Oct 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Take hypoglycemia-inducing medications
Other illness
- 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
- Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.
Other
- Be pregnant/lactating women
- Have a diagnosis of sleep apnea
Who the study is looking for
- 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.
Age in the registry: 16 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ottawa Hospital Research Insitute Coordinator of this site? Confirm its status | Ottawa | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.