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:
2025-12-25 @ 1:38 AM
Ignite Modification Date:
2025-12-25 @ 1:38 AM
NCT ID:
NCT06105294
Eligibility Criteria:
Inclusion Criteria:
* adults diagnosed with bipolar disorder and currently receiving medical care for their bipolar disorder.
* Experiencing schedule/sleep or circadian problem in the past 3 months
* Medication regimens stable for past month
* Adequate English language skills for taking part in the program.
* Living in California.
Exclusion Criteria:
* Cognitive deficits (Screening OMC Test)
* Current: psychosis, (hypo)mania, major depressive episode, substance/alcohol use disorders, eating disorder diagnoses or acute suicidal risk (MINI interview; see DSM5 TRE screening)
* High scores (\> 5) on the Screening Eating Disorder Examination Questionnaire
* Current shift work
* \>5 kg weight change within 3 months
* Pregnancy
* Breastfeeding
* Uncorrected hypo or hyperthyroidism
\* diabetes type 1
* Gastrointestinal conditions impairing nutrient absorption
* Medications contraindicated for fasting, including clozapine, glucose-lowering medications, diabetes-related injections, requiring food early morning or late evening, corticosteroids.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT06105294
Study Brief:
Protocol Section:
NCT06105294