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
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]
    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 ] [ 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.


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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT01209845

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

No publications provided

Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT01209845     History of Changes
Other Study ID Numbers: 0909005766
Study First Received: August 30, 2010
Last Updated: June 12, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Yale University:
depression
suicide ideation
emergency department
ketamine

Additional relevant MeSH terms:
Depression
Depressive Disorder
Suicide
Behavioral Symptoms
Mood Disorders
Mental Disorders
Self-Injurious Behavior
Ketamine
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Anesthetics, Dissociative
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014