Emergency Ketamine Treatment of Suicidal Ideation
Information source: University of Cincinnati
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Depression; Suicidal Ideation; Suicidal Impulses
Intervention: Intranasal Ketamine (Drug); Intranasal Saline Placebo (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: University of Cincinnati Official(s) and/or principal investigator(s):
Cheryl McCullumsmith, MD PhD, Principal Investigator, Affiliation: University of Cincinnati
Overall contact:
Faryal Mallick, Phone: 513-558-4997, Email: mallicfl@ucmail.uc.edu
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.
Clinical Details
Official title: Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Ketamine effect on Suicidal Ideation and Depression.
Secondary outcome: Assessment of Role of Mu Opioid Receptor
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
Eligibility
Minimum age: 18 Years.
Maximum age: 65 Years.
Gender(s): Both.
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 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 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
Locations and Contacts
Faryal Mallick, Phone: 513-558-4997, Email: mallicfl@ucmail.uc.edu
University of Cincinnati, Cincinnati, Ohio 45219, United States; Not yet recruiting
Faryal Mallick, MD, Phone: 513-558-4997, Email: mallicfl@ucmail.uc.edu
Cheryl McCullumsmith, MD PhD, Principal Investigator
Additional Information
Starting date: July 2015
Last updated: May 26, 2015
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