NCT06560957 SYNCED - SYNChronized Eating in Bipolar Depression Study
| NCT ID | NCT06560957 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Ottawa |
| Condition | Bipolar Depression |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2025-07-10 |
| Primary Completion | 2026-12-26 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2025-07-10 with a primary completion date of 2026-12-26.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Be 18-55 years old 2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5. 3. Have depression symptoms as indicated by a score of ≥12 on MADRS and ≤12 on YMRS. 4. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\* 5. Participants must be able to speak, read, write and understand English or French. 6. Be willing and able to provide informed consent. Exclusion Criteria: 1. Have any catatonic symptoms or eating disorder(s) as measured by the Quick Structured Clinical Interview for DSM-5® Disorders, QuickSCID-5. 2. Have any unstable or inadequately treated neurological and medical conditions. 3. Have had prior bariatric surgery. 4 Be taking hypoglycemia inducing medications. 5\. 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. 8\. 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). 10\. 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.
Contact & Investigator
Gayatri Saraf, MD
PRINCIPAL INVESTIGATOR
The Ottawa Hospital
Frequently Asked Questions
Who can join the NCT06560957 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 55 Years, studying Bipolar Depression. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06560957 currently recruiting?
Yes, NCT06560957 is actively recruiting participants. Contact the research team at deruscuklu@ohri.ca for enrollment information.
Where is the NCT06560957 trial being conducted?
This trial is being conducted at Ottawa, Canada.
Who is sponsoring the NCT06560957 clinical trial?
NCT06560957 is sponsored by University of Ottawa. The principal investigator is Gayatri Saraf, MD at The Ottawa Hospital. The trial plans to enroll 40 participants.
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