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 @ 1:12 AM
Ignite Modification Date:
2025-12-25 @ 1:12 AM
NCT ID:
NCT01944293
Eligibility Criteria:
INCLUSION CRITERIA:
* Bipolar depression with current major depressive episode (MDE). Participants may be psychiatric medication-free, or if on psychiatric medication, not responding adequately given current MDE with suicidal ideation.
* Moderate to severe suicidal ideation
* 18-65 years old
* Patients will only be enrolled if they agree to voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI) for infusion phase of treatment.
* Pre-menopausal female participants of child-bearing potential must be willing to use an acceptable form of birth control during study participation such as condoms, diaphragm, oral contraceptive pills
* Able to provide informed consent
* Subjects 61-65 years old must score 25 or higher on the Mini-Mental State Examination (MMSE) at screening
EXCLUSION CRITERIA:
* Unstable medical condition or neurological illness, including baseline hypertension (BP\>140/90) or significant history of cardiovascular illness
* Significant ECG abnormality
* Pregnancy and/or lactation
* Current psychotic symptoms
* Contraindication to any study treatment
* Current or past ketamine abuse or dependence ever (lifetime); any other drug or alcohol dependence within past 6 months; suicidality only due to binge substance use or withdrawal
* Inadequate understanding of English
* Prior ineffective trial of or adverse reaction to ketamine or midazolam
* Opiate use greater than total daily dose of 20mg Oxycodone or equivalent during the 3 days pre-infusion
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01944293
Study Brief:
Protocol Section:
NCT01944293