A Phase 2/3 interventional study of Intranasal Ketamine and Intranasal Saline Placebo in Depression, Suicidal Ideation and Suicidal Impulses, sponsored by University of Cincinnati. Status unknown at 1 site in United States. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2016-08-05.
Sponsored by University of Cincinnati · Phase 2/3, Interventional, and Treatment
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.
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
1,692 studies on the registry are indexed under Emergencies; 333 are open to participants now.
This study's planned enrollment of 60 is below the median of 145 across 931 interventional studies indexed under Emergencies.
Browse Emergencies studies →University of Cincinnati is the lead sponsor of 314 studies on the registry; 43 are open to participants now.
Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.
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Exclusion Criteria:
Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
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
0.2 mg / kg dose saline intranasal will be given in two separate doses on the day of hospital admission.
Drug: Intranasal Saline Placebo
Ketamine in liquid form to be distributed nasally by a board-certified physician while the subject is already in the hospital for suicidal ideation.
Also known as: ketamine
Intranasal Saline to be distributed by a board-certified physician while the patient is already hospitalized for suicidal ideation.
Also known as: saline
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
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.
Time frame: 4 weeks
Plan to share: No
This study is status unknown, as verified in Aug 2016. You cannot join it, but the record below documents what was studied.
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University of Cincinnati