Overview

This trial is active, not recruiting.

Conditions suicidal ideation, major depressive disorder
Treatments ketamine, saline
Phase phase 3
Sponsor Tel-Aviv Sourasky Medical Center
Start date January 2014
End date January 2016
Trial size 100 participants
Trial identifier NCT02037503, TASMC-13-TH-0270-CTIL

Summary

Suicide attempts are a serious concern worldwide. Currently, existing drugs take about three weeks to show effect on suicidal thoughts and drives. Recent evidence suggests that intravenous Ketamine exerts a rapid effect in suicidal patients, even after a single injection. We aim to examine whether oral Ketamine is a safe and effective treatment in suicidal patients. Following a suicide attempt, patients will be randomized into a group that will be given Ketamine for 21 days and one that will receive placebo, and assessed using questionnaires and brain scans. We expect early improvements in suicide scales in the Ketamine group.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Patients will be treated for 21 days with daily oral placebo
saline
(Experimental)
Patients will be treated for 21 days with daily oral Ketamine
ketamine
(Experimental)
Patients will be treated for 21 days with daily oral Ketamine
ketamine
(Placebo Comparator)
Patients will be treated for 21 days with daily oral placebo
saline

Primary Outcomes

Measure
Resolution of suicidal ideation
time frame: within 3 weeks of enrolement

Secondary Outcomes

Measure
Improvement in depression indices
time frame: within 3 weeks of treatment

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

Inclusion Criteria: Suicidal Ideation group: 1. Any person admitted to the emergency room department after a suicide attempt , defined as requiring medical intervention - not just a psychiatrist ( surgical or pharmacological treatment but also the need for observation ) . 2. The need for medical intervention will be defined by the ER ED physician 3. Ages 18-65 For the depression group: 1. Diagnosed with major depression according to DSM VI. 2. Ongoing depression (according to DSM criteria) despite treatment with at least two antidepressants in adequate dosages and for longer than three weeks. 3. Ages 18-65 - Exclusion Criteria for all groups: 1. Psychotic state instate in the examination 2. Diagnosis of schizophrenia / schizoaffective disorder 3. Drug or alcohol abuse as is revealed in by blood/urine tests 4. Patient in which, according to the examiner, there is primary or secondary gain. 5. Patient , which, at the time of his admission , is without any pharmacological treatment.

Additional Information

Official title Effect of Oral Ketamine Treatment on Suicidal Ideation and Drug Resistant Major Depression, a Clinical and fMRI Study
Description Suicide is a leading cause of death worldwide. Current strategies rely mostly on prevention, as there is no pharmacotherapy that seems to benefit patients in the acute phase of suicidal ideation. Conventional medications exert a beneficial effect only after three weeks. However, recent evidence suggests that intravenous Ketamine, an NMDA receptor antagonist, has a rapid and direct beneficial effect on suicidal ideation, even after a single dose. We hypothesize that daily oral administration of Ketamine in suicidal patients will prove a safe and effective outpatient treatment. In a double blind, placebo-controlled trial, patients admitted to the emergency department after a suicide attempt will be randomized into two groups: one will be given a daily sub-anesthetic dose of oral Ketamine, while the second group will receive a daily dose of placebo. Participants will be followed-up for 21 days. Some of the subjects will also undergo functional MRI scans before and after the first Ketamine intake. We expect significant early improvements in suicide and depression scales in the active treatment group. If daily oral Ketamine proves a safe, cost-effective, and beneficial treatment option for suicidal ideation, this will constitute a much needed new tool in preventing suicide ideation related morbidity and mortality.
Trial information was received from ClinicalTrials.gov and was last updated in January 2014.
Information provided to ClinicalTrials.gov by Tel-Aviv Sourasky Medical Center.