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Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial (LDK-SI)

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ClinicalTrials.gov Identifier: NCT01892995
Recruitment Status : Unknown
Verified February 2015 by Steven Schauer, Brooke Army Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : July 8, 2013
Last Update Posted : February 16, 2015
Sponsor:
Information provided by (Responsible Party):
Steven Schauer, Brooke Army Medical Center

Brief Summary:
This study will enroll patients presenting to the emergency department with acute suicidal ideation meeting inclusion and exclusion criteria. Patients will be randomized to one of three arms: ketamine (intervention) or diphenhydramine (control) or placebo (control). Serial measurements will be made in the ED and at follow-up intervals.

Condition or disease Intervention/treatment Phase
Suicide Drug: Ketamine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
Study Start Date : June 2015
Estimated Primary Completion Date : December 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Suicide
Drug Information available for: Ketamine

Arm Intervention/treatment
Experimental: Ketamine
active arm
Drug: Ketamine
Sham Comparator: Diphenhydramine
sham arm
Drug: Ketamine
Placebo Comparator: Saline
placebo
Drug: Ketamine



Primary Outcome Measures :
  1. Change in Beck Scale for Suicidal Ideation [ Time Frame: 2 hours ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients age 18 to less than 75 who present to the SAMMC ED with either overt or incidental suicidal ideations with a SADPERSONS score 5 or greater that the treating provider feels warrant formal evaluation.

Exclusion Criteria:

  • -Poor vital sign stability hypoxia: O2 < 95%, hypotension: SBP< 90 hypertension: SBP>180 Heart rate: < 50 or >120 Respiratory Rate: <10 or >30
  • Altered mental status or intoxication
  • Patient is unwilling to participate or provide informed consent
  • Any allergy to ketamine or diphenhydramine
  • Patient is female of child-bearing age and unwilling to provide urine or blood for HCG analysis
  • Pregnancy or breast feeding
  • Presence of chronic oxygen-dependent pulmonary disease, liver cirrhosis, or renal disease requiring dialysis
  • Presence of ischemic heart disease, heart failure, or a history of unstable dysrhythmias
  • Presence of intracranial mass or vascular lesion.
  • Presence of a history of psychosis or hallucinations (as assessed by electronic chart review)
  • Weight greater than 115 kg or less than 45kg
  • History of increased intracranial pressure/hypertensive hydrocephalus
  • Non-English speaking patients
  • Patient is acutely psychotic
  • Provider feels that patient currently or likely will require chemical and/or physical restraints
  • History of prolonged QT-interval

Information from the National Library of Medicine

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): NCT01892995


Contacts
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Contact: Steven G Schauer, DO 2109160808 sgschauer@gmail.com
Contact: Shawn M Varney, DO 2109160808 shawn.m.varney.mil@mail.mil

Locations
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United States, Texas
Brooke Army Medical Center Not yet recruiting
Fort Sam Houston, Texas, United States, 78234
Sponsors and Collaborators
Brooke Army Medical Center

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Responsible Party: Steven Schauer, CPT, Brooke Army Medical Center
ClinicalTrials.gov Identifier: NCT01892995     History of Changes
Obsolete Identifiers: NCT02367586
Other Study ID Numbers: BAMC-385833-1
First Posted: July 8, 2013    Key Record Dates
Last Update Posted: February 16, 2015
Last Verified: February 2015
Keywords provided by Steven Schauer, Brooke Army Medical Center:
suicide
ketamine
low-dose ketamine
suicidal ideations
emergency department
Additional relevant MeSH terms:
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Emergencies
Suicide
Suicidal Ideation
Disease Attributes
Pathologic Processes
Self-Injurious Behavior
Behavioral Symptoms
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action