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
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|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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||18 Years to 65 Years (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Males and females
- Ages 18-65
- All races and ethnicities
- Willing and able to provide informed consent
- A cutoff score of >3 on the Beck Scale for Suicidal Ideation
- >2 on the Columbia Scale for Suicide Severity Rating
- Pregnancy or lactation; women of reproductive potential must have a negative urine pregnancy test
- Post-partum state (within 2 months of delivery)
- Homicide risk as determined by clinical interview
Any of the following Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) diagnoses:
- Any current primary psychotic disorder
- Acute intoxication or withdrawal from alcohol or any other substance of abuse, as determined by clinical interview and urine drug screen except opioids
- use of any hallucinogen (except cannabis), in the last month
- Any dissociative disorder
- Pervasive developmental disorder
- Cognitive disorder
- Cluster A personality disorder
- Anorexia nervosa.
- Treatment with any medication known to affect the N-methyl-D-aspartate (NMDA) receptor system (e.g., lamotrigine, acamprosate, memantine, riluzole, or lithium)
- Any known hypersensitivity or serious adverse effect with ketamine
- Any clinically-significant medication or condition that would preclude the use of ketamine
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|
|Responsible Party:||Cheryl McCullumsmith, Principal Investigator, University of Cincinnati|
|Other Study ID Numbers:||
|First Posted:||July 8, 2014 Key Record Dates|
|Last Update Posted:||August 5, 2016|
|Last Verified:||August 2016|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
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