Clinical trial NCT06504342: Clocks in Sync - Circadian Rhythm and Bipolar Mania
Official title: Pilot Trial of Time Restricted Eating to Support an Adaptive Innovative Clinical Trial of Combined Chronotherapies for Mania in Bipolar Disorder
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bipolar Disorder
Mania
Keywords: Chronotherapy
Blue-blocking glasses
Time-restricted eating
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
First posted: 2024-07-16
Enrollment: 30
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Intervention model description: 2 by 2 factorial design. Only 3 of the 4 arms will be implemented, with the double control arm not implemented in the pilot.
Primary purpose: TREATMENT

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 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.

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 disorder, with an equity, diversity, and inclusion plan to ensure broad demographic representation.

The investigators' long-term goal is to conduct an innovative adaptive, 2x2 factorial study of these two interventions to determine the effects of each individual component and potential synergistic interactions. An adaptive design will allow interim analyses for sample size during which futility can also be assessed. This may potentially reduce cost and time of the later full trial, while ensuring that relevant findings are obtained. To inform a later 2x2 factorial study, researchers will need to gather data on the feasibility of time restricted eating in mania and identify any forms of support required to facilitate this chronotherapy. This is a randomized, parallel three group pilot study of blue-blocking glasses, time restricted eating, or blue-blocking glasses plus time-restricted eating in inpatients with mania. This project has three specific aims:

Aim 1: To assess the feasibility of time restricted eating (10:14 of diurnal eating to nocturnal fasting based on patient partners' input) as an adjunctive treatment for mania in an inpatient setting. Feasibility will be assessed through monitoring of adherence and qualitative semi-structured interviews with patient participants when they exit the study and staff near the study end date. The purpose of these interviews is to identify any challenges or barriers in implementing this treatment, alone or in combination with blue blocking glasses, and what supports might be needed. The research team will also assess willingness to participate in the study through assessment of participation rates and reasons for accepting or declining.

Aim 2: The investigators will secondarily compare differences between groups on the Young Mania Rating Scale (YMRS), which will be the primary outcome for the future trial.

Aim 3 (exploratory): To explore changes in measures of circadian rhythms and sleep, including as measured with actigraphy and other non-invasive monitoring measures, with the interventions and in relation to recovery from mania.

Eligibility 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.

Primary outcomes:
measure: Feasibility of Time-Restricted Eating: 1) Study Participation
timeFrame: Over the lifetime of the study starting at the first patient approached until recruitment is stopped.
measure: Feasibility of Time-Restricted Eating: 2) Adherence to Protocol
timeFrame: Baseline to Week 2 or until discharge, whichever comes first
measure: Feasibility of Time-Restricted Eating: 3) Qualitative Interviews
timeFrame: One interview prior to the participant's discharge, at the end of their participation in the study.
Secondary outcomes:
measure: Change in the Young Mania Rating Scale
timeFrame: Baseline to Week 2 or until discharge, whichever comes first
measure: Change in Montgomery-Åsberg Depression Rating Scale (MADRS) score
timeFrame: Baseline to Week 2 or until discharge, whichever comes first
measure: Change in the General Anxiety Disorder Questionnaire- 7-Item Measuring Severity of Anxiety Symptoms (GAD-7)
timeFrame: Baseline to Week 2 or until discharge, whichever comes first
measure: Change in The Morning Evening Questionnaire - 19-Item Self-Assessment Questionnaire for Sleep Rhythms, Habits and Fatigue (MEQ)
timeFrame: Baseline; Week 1; Week 2 or until discharge, whichever comes first
measure: Change in The Pittsburgh Sleep Quality Index - 18-Item Self-Assessment to Evaluate Sleep Quality (PSQI)
timeFrame: Baseline; Week 1; Week 2 or until discharge, whichever comes first
measure: Change in Circadian Rhythms: 1) Actigraphy
timeFrame: One week of continuous wearing starting at the Baseline visit.
measure: Change in Circadian Rhythms: 2) Heart Rate
timeFrame: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
measure: Change in Circadian Rhythms: 3) Body Temperature
timeFrame: Two 24-hour periods: one starting at the Baseline visit and the other starting at the Week 1 visit.
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Insitute
state: Ontario
Study officials:
affiliation: Ottawa Hospital Research Institute
name: Jess G Fiedorowicz, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References: