Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder

Status: Recruiting
Location: See location...
Intervention Type: Device, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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 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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 16
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Ottawa Hospital Research Insitute
RECRUITING
Ottawa
Contact Information
Primary
Jess G Fiedorowicz, MD, PHD
jfiedorowicz@toh.ca
+1 613-798-5555
Backup
Jessica Yu, MSc
jesyu@ohri.ca
Time Frame
Start Date: 2024-09-17
Estimated Completion Date: 2025-10
Participants
Target number of participants: 30
Treatments
Experimental: Blue-blocking glasses and time-restricted eating
Participants will be wearing the experimental blue-blocking glasses and follow time-restricted eating from 6pm-8am.
Active_comparator: Blue-blocking glasses and no time-restricted eating
Participants will only be wearing the experimental blue-blocking glasses from 6pm-8am.
Active_comparator: Lightly tinted glasses and time-restricted eating
Participants will be wearing the control lightly tinted glasses and follow time-restricted eating from 6pm-8am.
Related Therapeutic Areas
Sponsors
Leads: Ottawa Hospital Research Institute

This content was sourced from clinicaltrials.gov