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 @ 3:48 PM
Ignite Modification Date:
2025-12-24 @ 3:48 PM
NCT ID:
NCT03395392
Eligibility Criteria:
Inclusion Criteria:
* Diagnosed with bipolar disorder by a qualified rater according to the criteria defined in the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and supported by the Mini International Neuropsychiatric Interview (MINI) 7.0.2.
* Confirmed active suicidal ideation (without the intention to act) as evidenced by an answer of 'Yes' on item 3 and/or item 4 and not requiring hospitalization at Screening and an answer of "No" on item 5 of the C-SSRS.
* A total score greater than or equal to 30 on the 10 items of the MADRS.
* Subject has no co-morbidities as ascertained by medical history, physical examination (including measurement of vital signs), clinical laboratory evaluations, and electrocardiogram (ECG)
Exclusion Criteria:
* Subject has current DSM-5 diagnosis of moderate or severe substance use disorder (except marijuana or tobacco use disorder) within the 12 months prior to Screening.
* Subject has a lifetime history of:
* phencyclidine (PCP)/ketamine drug abuse, or
* failed use of ketamine for depression or suicidality.
* Subject has schizophrenia or schizoaffective disorder, or any history of psychotic symptoms when not in an acute bipolar mood episode.
* Subject has a current major psychiatric disorder, diagnosed at Screening
* Subject has been prescribed more than one agent in each of the following categories at randomization:
* Approved SSRIs
* Approved serotonin and norepinephrine reuptake inhibitors (SNRIs)
* Approved tetracyclic antidepressants (TeCAs)
* Approved Mood stabilizers (e.g., lithium, valproic acid, and lamotrigine)
* Subject has signs and symptoms of active or residual COVID-19, or unresolved symptoms of COVID-19 that impact health
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT03395392
Study Brief:
Protocol Section:
NCT03395392