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Ketamine for Low Mood States in the ER

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: September 27, 2010
Last Update Posted: June 13, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Yale University
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.

Condition Intervention
Depression Suicide Ideation Drug: ketamine

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Low Dose Ketamine for Low Mood States: An Emergency Department Feasibility Study for Depressed Patients

Resource links provided by NLM:

Further study details as provided by Yale University:

Primary Outcome Measures:
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 40, 80, 120, 240 minutes after administration of drug ]
    The MADRS measures mood (depression) and item 10 measures suicide ideation.

Secondary Outcome Measures:
  • 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 ]
    All patient subjects are admitted and we will follow them in the hospital and for 2 weeks after hospital discharge.

Enrollment: 14
Study Start Date: April 2010
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: ketamine
    intravenous ketamine(0.2 mg/kg) over 1-2 minutes IV
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).

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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): NCT01209845

United States, Connecticut
Yale New Haven Hospital Emergency Department
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
Principal Investigator: Gregory L Larkin, MD Yale University School of Medicine, Department of Emergency Medicine
  More Information

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01209845     History of Changes
Other Study ID Numbers: 0909005766
First Submitted: August 30, 2010
First Posted: September 27, 2010
Last Update Posted: June 13, 2012
Last Verified: June 2012

Keywords provided by Yale University:
suicide ideation
emergency department

Additional relevant MeSH terms:
Behavioral Symptoms
Self-Injurious Behavior
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action