Unknown statusPhase 3

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

NCT02037503 · Tel-Aviv Sourasky Medical Center

Closed to entry

Status

Not accepting participants

Phase 3

Phase

100

Target enrolment

Study sites

Outside the US

What it is testing

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

Summary as written by the trial’s own sponsor and published on ClinicalTrials.gov API v2. It is the sponsor’s description, reproduced unedited, not an assessment by this site.

What counts as success

Primary outcome measures

Resolution of suicidal ideation
Measured over within 3 weeks of enrolement

A trial succeeds or fails on its primary outcome, declared in advance. Everything else it reports is secondary by definition.

Who can take part

Eligibility, as published

18 Years to 65 Years

Ages

All

Sex

Not accepted

Healthy volunteers

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 For the romantic relationship breakup: 1\. Participants that have experienced a meaningful romantic relationship break-up within the past 12 months \- 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.

Where

1 study site

Facility	City	Region	Country
Tel Aviv Sourasky Medical Center	Tel Aviv	N/A = Not Applicable	Israel

On the registry

Contact the trial directly

This site does not enrol anyone and is not involved in this trial. To ask about taking part, use the sponsor’s own contact details on the official registry record, which is also where the most current version of everything above lives.

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NCT02037503 on ClinicalTrials.gov →

Last updated in the registry 2020-04-02. Registry records change; this page reflects the data build of 2026-08-25.

Where this trial sits

Substance

Ketamine

Indication

All 3 trials from Tel-Aviv Sourasky Medical Center →