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

NCT02037503 | Unknown Phase 3

• 1 other identifier: TASMC-13-TH-0270-CTIL
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Suicidal Ideation; Major Depressive Disorder; Healthy Participants

Outcome Measures

Primary Outcomes (1)

• Resolution of suicidal ideation

  within 3 weeks of enrolement

Secondary Outcomes (1)

• Improvement in depression indices

  within 3 weeks of treatment

Other Outcomes (2)

• Study adherence

  within 3 weeks after commencing treatment

• The visual analogue pain intensity scale

  During the experiment session

Study Arms (5)

Placebo for drug resistant depression

PLACEBO COMPARATOR

Patients will be treated for 21 days with daily oral placebo

Drug: Saline

Ketamine for suicidal ideation

EXPERIMENTAL

Patients will be treated for 21 days with daily oral Ketamine

Drug: Ketamine

Ketamine for drug resistant depression

EXPERIMENTAL

Patients will be treated for 21 days with daily oral Ketamine

Drug: Ketamine

Placebo in suicidal ideation

PLACEBO COMPARATOR

Patients will be treated for 21 days with daily oral placebo

Drug: Saline

Healthy Participants

EXPERIMENTAL

Healthy participants that underwent a romantic relationship breakup will attend in tow experimental sessions, one with placebo and one with ketamine. Sessions will be separated within the range of 1 to 6 weeks

Drug: Ketamine; Drug: Saline

Interventions

Ketamine DRUG

Healthy Participants; Ketamine for drug resistant depression; Ketamine for suicidal ideation

Saline DRUG

Healthy Participants; Placebo for drug resistant depression; Placebo in suicidal ideation

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Suicidal Ideation group:
• 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 ) .
• The need for medical intervention will be defined by the ER ED physician
• Ages 18-65
• For the depression group:
• Diagnosed with major depression according to DSM VI.
• Ongoing depression (according to DSM criteria) despite treatment with at least two antidepressants in adequate dosages and for longer than three weeks.
• Ages 18-65
• For the romantic relationship breakup:
• \. Participants that have experienced a meaningful romantic relationship break-up within the past 12 months

You may not qualify if:

• Psychotic state instate in the examination
• Diagnosis of schizophrenia / schizoaffective disorder
• Drug or alcohol abuse as is revealed in by blood/urine tests
• Patient in which, according to the examiner, there is primary or secondary gain.
• Patient , which, at the time of his admission , is without any pharmacological treatment.

Sponsors & Collaborators

• Tel-Aviv Sourasky Medical Center: lead

Study Sites (1)

Tel Aviv Sourasky Medical Center

Tel Aviv, N/A = Not Applicable, 64288, Israel

RECRUITING

Related Publications (1)

• Domany Y, Bleich-Cohen M, Tarrasch R, Meidan R, Litvak-Lazar O, Stoppleman N, Schreiber S, Bloch M, Hendler T, Sharon H. Repeated oral ketamine for out-patient treatment of resistant depression: randomised, double-blind, placebo-controlled, proof-of-concept study. Br J Psychiatry. 2019 Jan;214(1):20-26. doi: 10.1192/bjp.2018.196. Epub 2018 Sep 24.

  PMID: 30246667 DERIVED

MeSH Terms

Conditions

Suicidal Ideation; Depressive Disorder, Major

Interventions

Ketamine; Sodium Chloride

Condition Hierarchy (Ancestors)

Suicide; Self-Injurious Behavior; Behavioral Symptoms; Behavior; Depressive Disorder; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Central Study Contacts

Talma Hendler, MD

CONTACT

97236973953

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2014
• First Posted: January 16, 2014
• Study Start: January 1, 2014
• Primary Completion: May 1, 2020
• Study Completion: May 1, 2020
• Last Updated: April 2, 2020

Record last verified: 2019-11

Locations

IL (1)