Ketamine for Suicidality in Bipolar Depression

• Status: Completed
• Trial end date: 2018-10-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from bipolar depression.

The first drug, ketamine, is an experimental antidepressant that early studies have shown may quickly reduce suicidal thoughts, but we are not sure how well it may work. Midazolam, the comparison drug, is not thought to reduce depression or suicidal thoughts.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York State Psychiatric Institute
• Collaborator: Brain & Behavior Research Foundation
• Treatments: Ketamine; Midazolam

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