Ketamine For Suicidal Ideation
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||Investigating Rapid Anti-Suicidal Ideation Effects of Intravenous (IV) Ketamine in Hospitalized Patients|
- Change in Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: baseline ] [ Designated as safety issue: No ]Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.
- Change in Beck Scale for Suicidal Ideation (BSSI) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: No ]Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide.
- Montgomery-Asberg Depression Rating Scale (MADRS) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: No ]The MADRS is a 10-item instrument used for the evaluation of depressive symptoms in adults and for the assessment of any changes to those symptoms.
- Patient Rated Inventory of Side Effects (PRISE) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: Yes ]The PRISE assesses the presence of treatment side effects in nine organ/function systems (gastrointestinal, nervous system, heart, eyes/ears, skin, genital/urinary, sleep, sexual functioning, and other)
- Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: Yes ]a comprehensive, semi-structured interview measure that uniquely measures the full spectrum of suicidality including passive and active suicidal ideation, suicidal intent as well as suicidal behaviors
- The Young Mania Rating Scale (YMRS) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: Yes ]an 11-item questionnaire, used to assess manic symptoms based on the patient's subjective report of his or her clinical condition
- The Brief Psychiatric Rating Scale (BPRS) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: Yes ]to assess acute behavioral changes during the infusions
- The Clinician-Administered Dissociative States Scale (CADSS) [ Time Frame: 24 hours post infusion ] [ Designated as safety issue: Yes ]to measure dissociative effects during the infusions
|Study Start Date:||January 2012|
|Study Completion Date:||September 2014|
|Primary Completion Date:||September 2014 (Final data collection date for primary outcome measure)|
single dose IV ketamine, .5mg/kg
single dose IV ketamine, .5mg/kg infused over 40 minutes
Other Name: N-methyl-D-aspartate (NMDA) glutamate receptor antagonist
Placebo Comparator: Midazolam
single dose IV midazolam, .45mg/kg
single dose IV midazolam, .45mg/kg infused over 40 minutes
Depression is a debilitating disorder that affects 12-20% of population and is among the top five leading causes of burden of disease worldwide (Kruijshaar ME 2005). Suicide associated with depression and other psychiatric disorders is a pervasive public health problem and results in almost one million deaths per year. Unfortunately, current treatments for severe depression have limited efficacy for suicidality, specifically due to the slow time course of change in suicidal thoughts. Recently ketamine, a glutamate-modulating agent, was shown to have antidepressant and anti-suicidal effect in outpatient depressed patients. The proposed study will test the ability of a single sub-anesthetic intravenous (IV) dose of the glutamate NMDA receptor antagonist, ketamine, to provide rapid decrease in suicidal ideation (SI) in patients hospitalized with SI. In this randomized parallel-arm placebo controlled trial, ketamine is compared to midazolam, which is expected to mimic some of the acute subjective effects of ketamine but not have any sustained antidepressant effects.
Specific Aim 1: To determine feasibility and tolerability of a single low-dose IV infusion of ketamine in patients with prominent SI and elevated risk for suicide.
Hypothesis 1: Ketamine administration will be feasible and well tolerated in patients admitted to a psychiatric hospital with SI.
Specific Aim 2: To test the efficacy of a single IV dose of ketamine, compared to an anesthetic control condition (midazolam), to rapidly reduce SI in a controlled hospital setting.
Hypothesis 2: Ketamine will be associated with significant and rapid reductions in SI and depressive symptoms within 24 hours.
This study will test the rapid anti-suicidal effect of a single IV dose of the N-methyl-D-aspartate (NMDA) glutamate receptor antagonist ketamine in suicidality compared with the clinical response to a single IV dose of the short-acting benzodiazepine midazolam. Midazolam is able to induce transient neuropsychiatric effects mimicking ketamine and therefore is expected to protect the integrity of the blind. Participants will continue to receive standard treatment for their psychiatric condition throughout the trial. This unique "proof-of-concept" study in suicidal patients will be conducted over three-year period.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01507181
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10027|
|Principal Investigator:||James Murrough, MD||Icahn School of Medicine at Mount Sinai|