Emergency Ketamine Treatment of Suicidal Ideation
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|ClinicalTrials.gov Identifier: NCT02183272|
Recruitment Status : Unknown
Verified August 2016 by Cheryl McCullumsmith, University of Cincinnati.
Recruitment status was: Recruiting
First Posted : July 8, 2014
Last Update Posted : August 5, 2016
|Condition or disease||Intervention/treatment||Phase|
|Depression Suicidal Ideation Suicidal Impulses||Drug: Intranasal Ketamine Drug: Intranasal Saline Placebo||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Ketamine as an Adjunctive Treatment of Acute Suicidal Ideation in the Emergency Setting.|
|Study Start Date :||August 2016|
|Estimated Primary Completion Date :||November 2017|
|Estimated Study Completion Date :||July 2018|
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.
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.
Other Name: ketamine
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.
Drug: Intranasal Saline Placebo
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Other Name: saline
- Ketamine effect on Suicidal Ideation and Depression. [ Time Frame: 4 weeks ]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.
- Assessment of Role of Mu Opioid Receptor [ Time Frame: 4 weeks ]To assess the role of specific mu opioid receptor genetic variants in prediction of response to ketamine to alleviate suicidal ideation.
- Assessment of Changes of Biological Markers [ Time Frame: 4 weeks ]To assess the changes in biological markers of suicide risk such as linguistic patterns, voice and facial movements after ketamine treatment compared to baseline.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02183272
|Contact: Faryal Mallickfirstname.lastname@example.org|
|United States, Ohio|
|University of Cincinnati||Recruiting|
|Cincinnati, Ohio, United States, 45219|
|Contact: Faryal Mallick, MD 513-558-4997 email@example.com|
|Principal Investigator: Cheryl McCullumsmith, MD PhD|
|Principal Investigator:||Cheryl McCullumsmith, MD PhD||University of Cincinnati|