SYNCED - SYNChronized Eating in Bipolar Depression Study

NCT06560957 | Recruiting DMC

• 1 other identifier: 20240310-01H
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Bipolar disorders (BD) are a group of complex disorders that impact mood, behaviour and cognition and are known to cause significant suffering and impairment. Circadian rhythm (your internal day/night "clock") disruption, which can involve changes in sleep-wake cycles, frequently occurs in BD. Both depression and mania are accompanied by circadian disruption. These disruptions are hypothesized to lead to mood worsening, metabolic dysfunction and inflammation. If circadian dysfunction plays a significant role in the symptoms and trajectory of BD, then treatment approaches that target these functions may lead to better outcomes. One such approach is dietary interventions. Time restricted eating (TRE) is a dietary tool that restricts the eating to an 8-12 hour window, without changing diet quality or caloric intake. Studies involving time restricted eating have been done in other conditions with promising results. There have been no studies done for mood disorders in general or bipolar disorder specifically. In this proposal, the investigators will assess two dietary interventions (TRE and nutritional counselling) to examine how TRE may represent a safe and viable adjunct to traditional treatments. The investigators aim to compare TRE with nutritional counselling, while all participants continue to receive usual care. Participants will receive support from a registered dietician and will be instructed on dietary habits. Half of participants will receive nutritional counselling and half will be asked to do TRE. Those in the TRE group will be asked to select a 10-hour window to consume all food and non-water beverages for the 8-week period. Participants will be asked to complete a screening visit to determine eligibility, and then will complete questionnaires at baseline, week 4 and week 8 examining symptoms of their illness and cognition. Participants will also provide a blood sample at baseline and week 8 for standard biochemistry tests, pregnancy testing (if applicable), and to examine inflammatory markers. Participants will also wear an actigraphy watch which provides wireless continuous monitoring of movements and ambient light. The primary outcome is feasibility and acceptability (do people agree to participate, complete the study, and follow the intervention; what do they think of the intervention). Secondary outcomes include changes in depression, anxiety, sleep, and cognition. Exploratory outcomes include inflammatory markers and circadian disruption.

Conditions

Bipolar Depression; Bipolar I Disorder; Bipolar II Disorder

Outcome Measures

Primary Outcomes (4)

• Number of participants who complete the study

  The investigators will consider the intervention feasible if 70% of participants complete follow-up.

  18 months

• Time to recruit all participants

  The investigators will consider the intervention feasible if 70% of participants complete follow-up.

  18 months

• Intervention adherence

  The investigators will consider the intervention acceptable if participant adherence to the intervention is at least 70% (i.e. participants adhere to the TRE intervention 40 days out of 56 days); ii) at least 50% of participants approached about the study agree to participate.

  18 months

• Rate of participation

  The investigators will consider the intervention acceptable if at least 50% of potential participants approached about the study agree to participate.

  18 months

Secondary Outcomes (13)

• Depression severity - Montgomery-Åsberg Depression Rating Scale

  Screening, Baseline (week 1), Week 4, Week 8

• Cognitive dysfunction - Cognitive Complaints in Bipolar Disorder Rating Assessment

  Baseline (week 1), Week 4, Week 8

• Cognitive Dysfunction - Screen for Cognitive Impairment in Psychiatry

  Baseline (week 1), Week 4, Week 8

• Anxiety severity - Hamilton Anxiety Rating Scale

  Baseline (week 1), Week 4, Week 8

• Anxiety severity - Generalized Anxiety Disorder-7

  Baseline (week 1), Week 4, Week 8

Other Outcomes (11)

• Change in circadian rhythms

  Week 0, Week 9

• Change in C-reactive protein levels

  Baseline (week 1), Week 8

• Change in cytokine levels

  Baseline (week 1), Week 8

Study Arms (2)

Group 1: Eating ad libitum, nutritional counselling plus treatment as usual

OTHER

Participants randomized to this group will be offered nutritional counselling from a registered dietician. They will also receive a check-in from the registered dietician at week 4. They will also continue to receive treatment as usual. Treatment as usual includes pharmacological treatment options such as mood stabilizers and/or atypical antipsychotics, and psychological treatments such as psychotherapy. No current treatments will be stopped to participate in the study. We will record changes made to the doses of medications during the trial. No new treatments will be started for the duration of the trial, including pharmacological and psychological treatments

Behavioral: Eating ad libitum with nutritional counselling

Group 2:Time-restricted eating plus treatment as usual

OTHER

In addition to the nutritional counselling and continuing treatment as usual outlined in Group 1, this group will be provided time restricted eating instruction. The experimental group will be instructed to select a consistent 10-h eating window between 06:00 and 19:00 for all days of the week to consume all food and beverages (except water) for the duration of the 8-week intervention. Adherence to the intervention will be monitored weekly through phone check-ins with the research assistant. At 4-weeks, the study dietician will have a 1-hour check in with participants to review progress and adherence to TRE and to address any difficulties the participants may be facing.

Behavioral: Time restricted eating

Interventions

Eating ad libitum with nutritional counselling BEHAVIORAL

Nutritional counselling will include customized advice delivered by a registered dietician about dietary choices while allowing individuals to eat at any time of day.

Group 1: Eating ad libitum, nutritional counselling plus treatment as usual

Time restricted eating BEHAVIORAL

Time restricted eating involves restricting the window in which calories are consumed to 8-10 hours, without altering diet quality or caloric intake. In this study, time restricted eating will be a consistent 10-h eating window between 06:00 and 19:00, considered an early TRE pattern, for all days of the week, as chosen by the participant. They will need to consume all food and beverages (except water) during this window for the duration of the 8-week intervention.

Group 2:Time-restricted eating plus treatment as usual

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Be 18-55 years old
• Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.
• Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS.
• Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\*
• Participants must be able to speak, read, write and understand English or French.
• Be willing and able to provide informed consent.

You may not qualify if:

• Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5.
• Have any unstable or inadequately treated neurological and medical conditions.
• Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications.
• \. Be pregnant or lactating. 6. Currently taking any stimulant medications. 7. Be participating in any other diet or weight management program for the duration of the trial.
• \. Have any contraindication to fasting as judged by the assessing clinician. 9. Recently (i.e. within the past 8 weeks) began structured psychotherapy (i.e. cognitive-behavioral therapy, interpersonal psychotherapy, family-focused therapy, or interpersonal and social rhythm therapy).
• \. Have any other medical condition, substance use disorder or suicidal ideation for which physician or investigator team expresses concern about safety or ability to participate in the study.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: collaborator
• University of Ottawa: lead

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

RECRUITING

MeSH Terms

Conditions

Bipolar Disorder

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Study Officials

• Gayatri Saraf, MD

  The Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Deniz Ruscuklu, BA

CONTACT

613-737-8899; deruscuklu@ohri.ca

Gayatri Saraf, MD

CONTACT

gsaraf@toh.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Psychiatrist and Associate Professor

Study Record Dates

• First Submitted: June 12, 2024
• First Posted: August 19, 2024
• Study Start: July 10, 2025
• Primary Completion (Estimated): December 26, 2026
• Study Completion (Estimated): February 26, 2027
• Last Updated: May 1, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)