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:
2026-03-26 @ 3:17 PM
Ignite Modification Date:
2026-03-26 @ 3:17 PM
NCT ID:
NCT07412132
Eligibility Criteria:
Inclusion Criteria:
1. Diagnosis of bipolar disorder (type I or II) confirmed by structured clinical interview;
2. acute major depressive episode of moderate or severe intensity;
3. no response to at least two adequate pharmacological interventions to treat the current episode.
Exclusion Criteria:
1. Current diagnosis of schizophrenia, dementia, intellectual disability, organic mental disorder (by clinical assessment). Comorbidity with other psychiatric disorders (personality disorders, anxiety disorders, substance use disorders, eating disorders, and attention deficit disorder) will be permitted provided the primary diagnosis is bipolar disorder;
2. acute suicidal ideation (defined by HAMD-17 item 3 ≥ 3 points or by clinical assessment);
3. current depressive episode with psychotic features (by clinical assessment);
4. suspected or confirmed pregnancy;
5. severe or unstable clinical illnesses;
6. previous history of non-response to an adequate course of at least 8 sessions of electroconvulsive therapy;
7. previous history of non-response to an adequate course of ketamine treatment.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT07412132
Study Brief:
Protocol Section:
NCT07412132