Ketamine for Acute Suicidal Ideation in the Emergency Department: Randomized Controlled Trial

NCT ID: NCT01892995

Last Updated: 2015-02-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

53 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-30

Brief Summary

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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

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Conditions

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Suicide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ketamine

active arm

Group Type EXPERIMENTAL

Ketamine

Intervention Type DRUG

Diphenhydramine

sham arm

Group Type SHAM_COMPARATOR

Ketamine

Intervention Type DRUG

Saline

placebo

Group Type PLACEBO_COMPARATOR

Ketamine

Intervention Type DRUG

Interventions

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Ketamine

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Steven Schauer

CPT

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brooke Army Medical Center

Fort Sam Houston, Texas, United States

Site Status

Countries

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United States

Central Contacts

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Steven G Schauer, DO

Role: CONTACT

2109160808

Shawn M Varney, DO

Role: CONTACT

2109160808

Other Identifiers

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BAMC-385833-1

Identifier Type: -

Identifier Source: org_study_id

NCT02367586

Identifier Type: -

Identifier Source: nct_alias

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