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

• Status: Unknown status
• Trial end date: 2020-05-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Tel-Aviv Sourasky Medical Center
• Treatments: Ketamine

Criteria

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.