CompletedPhase 4ketamine
Ketamine in the Treatment of Suicidal Depression
Sponsored by New York State Psychiatric Institute
NCT ID
NCT01700829
Target Enrollment
82 participants
Start Date
2012-06
Est. Completion
2017-07-31
About This Study
This study is designed to compare the effectiveness of two medications, Ketamine and Midazolam, for rapidly relieving suicidal thoughts in people suffering from 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.
Conditions Studied
Interventions
- •Ketamine
- •Midazolam
Eligibility
Age:18 Years - 65 Years
Healthy Volunteers:No
View full eligibility criteria
INCLUSION CRITERIA: * Unipolar 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 (See 2). * Moderate to severe suicidal ideation * 18-65 years old * Participants must agree to a voluntary admission to an inpatient research unit at the New York State Psychiatric Institute (NYSPI)for the infusion(s), for a brief stay, or longer if clinically necessary. * 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, or oral contraceptive pills. * Able to provide informed consent * Participants 61-65 years old must score a 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 * Pregnant or lactating * Diagnosis of bipolar disorder or psychotic disorder * Contraindication to any study treatment. * 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. * A diagnosis of sleep apnea.
Study Locations (1)
Columbia University/New York State Psychiatric Institute
New York, New York, United States