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 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT03310593
Eligibility Criteria:
Inclusion Criteria:
* Major depressive episode as part of bipolar I disorder or bipolar II disorder according to Fifth Edition of Diagnostic and Statistical Manual for Mental Disorders (DSM-5) and are able to provide written informed consent.
* Montgomery-Asberg Depression Rating Scale (MADRS) score ≥ 12 and MADRS items 1 (Apparent Sadness) and 2 (Reported Sadness) scores ≥ 2 at baseline.
* Young Mania Rating Scale (YMRS) ≤ 11.
* Currently prescribed lithium or valproic acid and derivates (divalproex sodium, sodium valproate) or atypical antipsychotics at therapeutic dosage for at least 04 weeks before the baseline.
* Females must test negative for pregnancy and must be using adequate birth control measures throughout the study.
Exclusion Criteria:
* Another concurrent mental or behavioral disorder that requires psychiatric attention in the past 6 months.
* Young Mania Rating Scale (YMRS) score \> 12.
* Current or past drug sensitivity/intolerance to cannabidiol.
* Substance Use Disorder according to DSM-5 within past 6 months, except for nicotine Substance Use Disorder.
* Clinically significant unstable medical illness, neurological disorders or inflammatory/autoimmune diseases.
* Any autoimmune, inflammatory or neurologic disorders that requires treatment with steroidal anti-inflammatory medications or immunotherapy with biologic drugs.
* Actively suicidal or homicidal risk.
* Females who are pregnant or breastfeeding
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT03310593
Study Brief:
Protocol Section:
NCT03310593