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

• ClinicalTrials.gov Identifier: NCT01892995
• Recruitment Status: Unknown
• First Posted: July 8, 2013
• Last Update Posted: February 16, 2015
• Sponsor: Brooke Army Medical Center
• Information provided by (Responsible Party): Steven Schauer, Brooke Army Medical Center

Tracking Information

• First Submitted Date: July 2, 2013
• First Posted Date: July 8, 2013
• Last Update Posted Date: February 16, 2015
• Study Start Date: June 2015
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: July 2, 2013): Change in Beck Scale for Suicidal Ideation [ Time Frame: 2 hours ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
• Official Title: Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment
• Condition: Suicide
• Intervention: Drug: Ketamine

Study Arms

• Experimental: Ketamine
  active arm
  Intervention: Drug: Ketamine
• Sham Comparator: Diphenhydramine
  sham arm
  Intervention: Drug: Ketamine
• Placebo Comparator: Saline
  placebo
  Intervention: Drug: Ketamine

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: July 2, 2013): 53
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 75 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01892995
• Other Study ID Numbers: BAMC-385833-1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Steven Schauer, Brooke Army Medical Center
• Study Sponsor: Brooke Army Medical Center
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: Brooke Army Medical Center
• Verification Date: February 2015