Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:50 PM
Ignite Modification Date:
2025-12-24 @ 6:50 PM
NCT ID:
NCT06560957
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT06560957
Study Brief:
Protocol Section:
NCT06560957