Ketamine For Suicidal Ideation

NCT01507181 | Completed Phase 4 Results DMC

• 1 other identifier: GCO 10-1589
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine the effects of Intravenous (IV) ketamine both in an outpatient population and with subjects on the inpatient unit with suicidal ideation (SI).

Conditions

Suicidal Ideation

Keywords

suicidal ideation; major depression; treatment resistant; ketamine; glutamate

Outcome Measures

Primary Outcomes (2)

• Change in Beck Scale for Suicidal Ideation (BSSI)

  Change in BSI score at 24 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.

  baseline and 24 hours post infusion

• Change in Beck Scale for Suicidal Ideation (BSSI)

  Change in BSI score at 48 hours following treatment as compared to baseline. Beck Scale is a 21-item self or clinician administered instrumentation used to measure the current intensity of patients' specific attitudes, behaviors and plans to commit suicide. Score range 0-42, with higher score indicating higher intensity.

  baseline and 48 hours post infusion

Secondary Outcomes (6)

• Montgomery-Asberg Depression Rating Scale (MADRS)

  up to 7 days post infusion

• Suicidality Item of the MADRS (MADRS-SI)

  24 hours post infusion

• The Young Mania Rating Scale (YMRS)

  baseline, 40 minutes post infusion, 240 minutes post infusion

• The Brief Psychiatric Rating Scale (BPRS)

  baseline, 40 minutes post infusion, and 240 minutes post infusion

• The Clinician-Administered Dissociative States Scale (CADSS)

  baseline, 40 minutes post infusion and 240 minutes post infusion

Study Arms (2)

Ketamine

EXPERIMENTAL

single dose IV ketamine, .5mg/kg

Drug: Ketamine

Midazolam

PLACEBO COMPARATOR

single dose IV midazolam, .45mg/kg

Drug: Midazolam

Interventions

Ketamine DRUG

single dose IV ketamine, .5mg/kg infused over 40 minutes

Also known as: N-methyl-D-aspartate (NMDA) glutamate receptor antagonist

Ketamine

Midazolam DRUG

single dose IV midazolam, .45mg/kg infused over 40 minutes

Midazolam

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking Male or female patients, 18-80 years
• Patients have voluntarily admitted themselves to an inpatient psychiatric unit at MSH or, regarding the outpatient population, have clinically significant suicidal ideation without intent to harm themselves
• Women of childbearing potential must have a negative pregnancy test
• Clinically significant suicidal ideation and score of ≥4 on MADRS item 10 for suicidality
• Each subject must have a level of understanding sufficient to agree to all tests and examinations required by the protocol and must sign an informed consent document

You may not qualify if:

• Lifetime history of schizophrenia or other primary psychotic disorder
• Current presence of psychotic symptoms
• Lifetime history of a clearly established psychotic episode
• Established diagnosis of Schizoid, Schizotypal or Paranoid personality disorder
• Urine toxicology screen positive for drugs of abuse on admission
• Substance abuse or dependence within the preceding 1 month
• Anticipated discharge within 7 days of study enrollment (for patients in the inpatient arm)
• Women who plan to become pregnant, are pregnant or are breast-feeding
• Concurrent course of electroconvulsive therapy (ECT)
• Any unstable medical illness including hepatic, renal, gastro-enterologic, respiratory, cardiovascular, endocrinologic, neurologic, immunologic, or hematologic disease
• Clinically significant abnormal findings of laboratory parameters, physical examination, or ECG
• The presence of any known or suspected contraindications to midazolam or ketamine including, but not limited to, known allergic reactions to these agents or acute intermittent porphyria
• Uncontrolled hypertension, defined as BP systolic \>160 or BP diastolic \>100 on medications
• Arrhythmia requiring medication
• Severe coronary artery disease, defined as Canadian Cardiovascular Status III or IV

Sponsors & Collaborators

• James Murrough: lead

Study Sites (1)

Icahn School of Medicine at Mount Sinai

New York, New York, 10027, United States

Location

Related Publications (1)

• Murrough JW, Soleimani L, DeWilde KE, Collins KA, Lapidus KA, Iacoviello BM, Lener M, Kautz M, Kim J, Stern JB, Price RB, Perez AM, Brallier JW, Rodriguez GJ, Goodman WK, Iosifescu DV, Charney DS. Ketamine for rapid reduction of suicidal ideation: a randomized controlled trial. Psychol Med. 2015 Dec;45(16):3571-80. doi: 10.1017/S0033291715001506. Epub 2015 Aug 12.

  PMID: 26266877 RESULT

MeSH Terms

Conditions

Suicidal Ideation; Depressive Disorder, Major

Interventions

Ketamine; N-Methylaspartate; Excitatory Amino Acid Antagonists; Midazolam

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; Aspartic Acid; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic; Excitatory Amino Acid Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Physiological Effects of Drugs; Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Limitations and Caveats

Sample size is small, increasing the likelihood of a false negative finding due to limited power. Unknown if the lack of significant separation between the treatment and control conditions at 24 h represents a true null finding or a false negative.

Results Point of Contact

• Title: Dr. J. W. Murrough
• Organization: Mood and Anxiety Disorders Program, Department of Psychiatry, Icahn School of Medicine at Mount Sinai

james.murrough@mssm.edu

212-241-7574

Study Officials

• James Murrough, MD

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: January 1, 2012
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: February 8, 2017
• Results First Posted: February 8, 2017

Record last verified: 2016-12

Locations

US (1)