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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02183272
Other study ID # Ketamine IIT
Secondary ID
Status Recruiting
Phase Phase 2/Phase 3
First received July 2, 2014
Last updated August 3, 2016
Start date August 2016
Est. completion date July 2018

Study information

Verified date August 2016
Source University of Cincinnati
Contact Faryal Mallick
Phone 513-558-4997
Email mallicfl@ucmail.uc.edu
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date July 2018
Est. primary completion date November 2017
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States University of Cincinnati Cincinnati Ohio

Sponsors (1)

Lead Sponsor Collaborator
University of Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Assessment of Changes of Biological Markers To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline. 4 weeks No
Primary Ketamine effect on Suicidal Ideation and Depression. To assess the acute efficacy and durability of effect over a 4 week time period of single dose of 0.2 mg/kg intranasal ketamine treatment on suicidal ideation and depression in individuals with acute suicidal ideation as measured by the Beck Scale for Suicidal Ideation (BSS) and the Montgomery-Asberg Depression Rating Scale (MADRS)as compared to placebo. 4 weeks No
Secondary Assessment of Role of Mu Opioid Receptor To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation. 4 weeks No
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