drugset / Trial / NCT02037503

The Effect of Ketamine on Mechanises Underlying Suicidal Ideation and Drug-resistant Major Depression

NCT02037503

Phase 3 Unknown 100 enrolled Tel-Aviv Sourasky Medical Center
RandomizedParallel-groupTriple-blindTreatment

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. As a secondary goal, this study will use IV ketamine in order to access the extent to which the experience of the embodied self mediate different levels of "embodied emotion". A better understanding of these relations will assist in unveiling the cognitive mechanism underlying the therapeutic effect of ketamine

Timeline

Start
2014-01
Primary completion
2020-05
Completion
2020-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ketamine Small molecule 1 mg/kg Oral