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Ketamine for Low Mood States in the ER

This study has been completed.
Information provided by (Responsible Party):
Yale University Identifier:
First received: August 30, 2010
Last updated: June 12, 2012
Last verified: June 2012
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).

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: 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 Identifier: NCT01209845     History of Changes
Other Study ID Numbers: 0909005766
Study First Received: August 30, 2010
Last Updated: June 12, 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 processed this record on August 17, 2017