SYNCED - SYNChronized Eating in Bipolar Depression Study

Launched by UNIVERSITY OF OTTAWA · Aug 15, 2024

Keywords

ClinConnect Summary

The SYNCED study is exploring how a specific eating pattern called time-restricted eating (TRE) might help people with bipolar depression. This involves eating all meals within a set window of time, usually 10 hours each day, while still receiving regular care for their condition. The goal is to see if this eating approach can improve mood, reduce anxiety, and enhance overall well-being in individuals diagnosed with bipolar I or bipolar II disorders. Participants will be supported by a registered dietitian and will also complete questionnaires and provide blood samples to help researchers understand how their symptoms change over the 8-week period.

To be eligible for the study, participants need to be between 18 and 55 years old and have a diagnosis of bipolar disorder with certain levels of depression symptoms. They should be willing to use email and a smartphone app throughout the trial. However, individuals with certain medical conditions, severe suicidal thoughts, or those currently on specific medications may not qualify. The study is not yet recruiting participants, but it aims to provide valuable insights into the potential benefits of dietary interventions for mood disorders.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Be 18-55 years old
• • 2. Have a diagnosis of bipolar I or bipolar II disorder, confirmed by the Structured Clinical Interview for the Diagnostic and Statistical Manual of Mental Disorders 5th edition (DSM-5) Research Version (SCID-RV)
• • 3. Have mild to moderate depression symptoms as indicated by a score of ≥12 and ≤30 on MADRS and ≤12 on Young Mania Rating Scale (YMRS).
• • 4. Be willing to use email for study activities
• • 5. Females of childbearing potential are willing to follow highly effective methods of contraception (mentioned below) for the duration of study\*
• • 6. Be able and willing to use email and a smartphone application for the duration of the trial
• • 7. Participants must be able to speak, read, write and understand English or French.
• • 8. Be willing and able to provide informed consent.
• Exclusion Criteria:
• • 1. Have clinically significant suicidal ideation, defined as ≥ 4 on MADRS suicide item
• • 2. Have any catatonic symptoms, eating disorders, borderline personality disorder and substance use disorders as measured by the Structured Clinical Interview for the DSM-5 Research Version (SCID-RV)
• • 3. Have any unstable or inadequately treated neurological and medical conditions
• • 4. Have had prior bariatric surgery
• • 5. Be taking hypoglycemia inducing medications
• • 6. Be pregnant or lactating
• • 7. Currently on stimulant medications
• • 8. Be participating in any other diet or weight management program for the duration of the trial.
• • 9. Have any contraindication to fasting as judged by the assessing clinician.
• • 10. Recently started taking a Canadian Network for Mood and Anxiety Treatments (CANMAT) recommended treatment18 for the management of acute bipolar depressive episode, but has not had a trial for a minimum of 6 weeks with adequate doses.
• • 11. 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).
• • 12. Have any other medical condition for which physician or investigator team expresses concern about safety or ability to participate in the study.