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 @ 11:47 AM
Ignite Modification Date:
2025-12-24 @ 11:47 AM
NCT ID:
NCT02800161
Eligibility Criteria:
Inclusion Criteria:
* Bipolar I and II patients aged between 18 and 65.
* Bipolar disorder type I or II and a current major depressive episode (Montgomery-Asberg Depression Rating Scale (MADRS) ≥18.
* Clinical Global Impression-Bipolar version (CGI-BP)≥4.
* All patients need to be receiving lithium at a steady dose (0.5-1.2 mmol/L) during at least 2 weeks prior to the study.
* Other mood stabilizers added to lithium are permitted but at steady dose during at least 2 weeks prior to the study.
* Other psychopharmacological treatments should be at stable dose 2 weeks prior to the study.
Exclusion Criteria:
* Exclusion criteria will be the presence of psychotic features, severe suicidal ideation (score of ≥5 on item 10 of MADRS).
* A severe personality disorder suggesting noncompliance.
* Diabetes Mellitus, any severe neurologic or other somatic illness and the use of somatic medication that could influence the mood.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT02800161
Study Brief:
Protocol Section:
NCT02800161