Emergency Ketamine Treatment of Suicidal Ideation

NCT ID: NCT02183272

Last Updated: 2016-08-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-31
• Study Completion Date: 2018-07-31

Brief Summary

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment.

Detailed Description

The objective of the current program of research will be to test whether intranasal ketamine treatment is more effective than placebo in reducing suicidal ideation in suicidal patients presenting for acute treatment in emergency department settings. Secondary objectives will test the effect of genotypic differences in the mu opioid receptor on efficacy of ketamine and the correlation of speech patterns and facial movement patterns with subjective reductions in suicidal ideation after ketamine treatment

Conditions

Depression; Suicidal Ideation; Suicidal Impulses

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Intranasal Ketamine

0.2 mg / kg dose of intranasal ketamine for treatment of suicidality will be given in two separate doses on the day of admission to the hospital.

Group Type: ACTIVE_COMPARATOR

Intranasal Ketamine

Intervention Type: DRUG

Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.

Intranasal Saline Placebo

0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.

Group Type: PLACEBO_COMPARATOR

Intranasal Saline Placebo

Intervention Type: DRUG

Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.

Interventions

Intranasal Ketamine

Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.

Intervention Type: DRUG

Intranasal Saline Placebo

Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.

Intervention Type: DRUG

Other Intervention Names

ketamine; saline

Eligibility Criteria

Inclusion Criteria

1. Males and females

2. Ages 18-65

3. All races and ethnicities

4. Willing and able to provide informed consent

5. A cutoff score of >3 on the Beck Scale for Suicidal Ideation

6. >2 on the Columbia Scale for Suicide Severity Rating

Exclusion Criteria

1. Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test

2. Post-partum state (within 2 months of delivery)

3. Homicide risk as determined by clinical interview

4. Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:

1. Any current primary psychotic disorder

2. Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids

3. use of any hallucinogen (except cannabis), in the last month

4. Any dissociative disorder

5. Pervasive developmental disorder

6. Cognitive disorder

7. Cluster A personality disorder

8. Anorexia nervosa.

5. Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)

6. Any known hypersensitivity or serious adverse effect with ketamine

7. Any clinically-significant medication or condition that would preclude the use of ketamine

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Cheryl McCullumsmith

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cheryl McCullumsmith, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Cincinnati

Locations

University of Cincinnati

Cincinnati, Ohio, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Faryal Mallick

Role: CONTACT

mallicfl@ucmail.uc.edu

513-558-4997

Facility Contacts

Faryal Mallick, MD

Role: primary

mallicfl@ucmail.uc.edu

513-558-4997

References

Domany Y, McCullumsmith CB. Single, Fixed-Dose Intranasal Ketamine for Alleviation of Acute Suicidal Ideation. An Emergency Department, Trans-Diagnostic Approach: A Randomized, Double-Blind, Placebo-Controlled, Proof-of-Concept Trial. Arch Suicide Res. 2022 Jul-Sep;26(3):1250-1265. doi: 10.1080/13811118.2021.1878078. Epub 2021 Feb 14.

Reference Type: DERIVED

PMID: 33583341 (View on PubMed)

Other Identifiers

Ketamine IIT

Identifier Type: -

Identifier Source: org_study_id