Ketamine for Low Mood States in the ER

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Yale University

ClinicalTrials.gov Identifier:

NCT01209845

First received: August 30, 2010

Last updated: June 12, 2012

Last verified: June 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

August 30, 2010

Last Updated Date

June 12, 2012

Start Date ^ICMJE

April 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 40, 80, 120, 240 minutes after administration of drug ] [ Designated as safety issue: No ]

The MADRS measures mood (depression) and item 10 measures suicide ideation.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01209845 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

recruitment success and retention of subjects in the ER [ Time Frame: initial recruitment of eligible subjects in the ER and for two weeks after administration of drug ] [ Designated as safety issue: No ]

All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Ketamine for Low Mood States in the ER

Official Title ^ICMJE

Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients

Brief Summary

The investigators hope to see if a commonly used drug such as ketamine could help depressed ER patients feel better and improve their mood quickly.

Detailed Description

Rapid-onset antidepressants could have important clinical impact if their benefits extended to Emergency Department (ED) patients. We hope to explore the preliminary feasibility, tolerability and efficacy of single-dose, intravenous (IV) ketamine in depressed ED patients who presented with suicide ideation (SI).

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Depression
Suicide Ideation

Intervention ^ICMJE

Drug: ketamine

intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV

Study Arm (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

December 2010

Primary Completion Date

December 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

adults (>18yrs) presenting to the Emergency department with symptoms of depression and/or suicide ideation (MADRS>30) with ability to give informed consent.
medically stable

Exclusion Criteria:

psychosis, bipolar, or other significant physical or mental illness
pregnancy
non-voluntary status
urine drug screen positive for drugs of abuse

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT01209845

Other Study ID Numbers ^ICMJE

0909005766

Has Data Monitoring Committee

Responsible Party

Yale University

Study Sponsor ^ICMJE

Yale University

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Gregory L Larkin, MD

Yale University School of Medicine, Department of Emergency Medicine

Information Provided By

Yale University

Verification Date

June 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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