Recruiting
Phase 2
Phase 3

Ketamine

Sponsor:

University of Cincinnati

Code:

NCT02183272

Conditions

Depression

Suicidal Ideation

Suicidal Impulses

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Intranasal Ketamine

Intranasal Saline Placebo

Study Details

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.

Conditions

Depression

Suicidal Ideation

Suicidal Impulses

Study ID

NCT02183272

Start date

Aug, 2016

Status verified date

Aug, 2016

Completion date

Jul, 2018

Anticipated

Primary completion date

Nov, 2017

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

placebo comparator: Intranasal Saline Placebo

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

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.

Intranasal Saline Placebo

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

Primary outcome measure

  • Ketamine effect on Suicidal Ideation and Depression. [ Time Frame: 4 weeks ]

Central Contacts and Locations

Central contacts

Faryal Mallick

513-558-4997mallicfl@ucmail.uc.edu

Locations

University of Cincinnati

Recruiting

Cincinnati, Ohio, United States, 45219

Contacts

Faryal Mallick, MD

513-558-4997mallicfl@ucmail.uc.edu

Principal Investigator:

Cheryl McCullumsmith, MD PhD

More Information

Sponsor

University of Cincinnati

Last update posted

Aug 5, 2016

Last verified

Aug, 2016

Keywords

  • Depression
  • Suicidal Ideation
  • Ketamine
  • Emergency Department

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Cincinnati on 2016-08-05.