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A Study of Ketamine as an Antidepressant

This study is currently recruiting participants.
Verified February 2013 by The University of New South Wales
Sponsor:
Collaborator:
Wesley Hospital, Kogarah
Information provided by (Responsible Party):
Colleen Loo, The University of New South Wales
ClinicalTrials.gov Identifier:
NCT01441505
First received: September 16, 2011
Last updated: February 20, 2013
Last verified: February 2013
History of Changes
  Purpose

Recently, interest has emerged in the use of ketamine as an antidepressant. Recent placebo-controlled clinical trials administering a single dose and an open label trial giving repeated doses shown that ketamine is markedly superior to placebo at reducing depression, including in treatment-resistant patients, and that its antidepressant effects have a very rapid onset.

This clinical study consists of two phases. In Phase I, participants who satisfy inclusion criteria will receive ketamine at variable doses (0.1mg/kg-0.5mg/kg) or a placebo (saline, or 0.01mg/kg midazolam) once a week over up to 6 weeks. If participants qualify for Phase II, they will receive repeated sessions of ketamine at variable doses over three weeks. During both phases, mood, psychiatric, and neuropsychological outcomes will be measured.


Condition Intervention Phase
Major Depressive Episode
 Drug: Ketamine
Drug: Saline or Midazolam (active placebo)
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Study of Ketamine as an Antidepressant

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by The University of New South Wales:

Primary Outcome Measures:
  • Change from baseline on depression rating scales [ Time Frame: Before, 4 hours after, and 24 hours after ketamine session ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Psychiatric side effects (BPRS, CADSS) and memory tests [ Time Frame: Cognitive battery done before and after 3 weeks; side effects measured immediately before and 4 hours after each ketamine session in both phases. ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 42
Study Start Date: September 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Ketamine
    Ketamine IV, IM, or SC will be administered in Phase I and II
    Drug: Saline or Midazolam (active placebo)
    Saline, or midazolam 0.01mg/kg will be administered in Phase I
Detailed Description:

This clinical study consists of two phases. In Phase I, participants will receive variable doses of intravenous, intramuscular, or subcutaneous ketamine (0.1-0.5mg/kg) or placebo (saline, or 0.01mg/kg midazolam) weekly for up to 6 consecutive weeks. Prior to receiving ketamine/placebo, participants' mood and psychiatric symptoms will be assessed. Once they have received their treatment, mood, psychiatric side effects, ketamine blood levels, heart rate, blood pressure and biomarkers will be assessed. Mood and cognitive performance be assessed again after 4 hours. Finally, mood will also be assessed the next day.

Some participants may be eligible to continue to Phase II. In this phase, participants will receive doses of ketamine approximately weekly for up to 6 months. During this phase, participants' mood, psychiatric, biomarkers and cognitive outcomes will be assessed.

The purpose of the trial is to investigate the antidepressant and safety effects of using ketamine as a treatment in depression.

  Eligibility

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

Inclusion Criteria:

  • Satisfy DSM-IV-TR criteria for Major Depressive Episode
  • 18 years or over
  • Able to give informed consent

Exclusion Criteria:

  • Diagnosis of schizophrenia, schizoaffective disorder, rapid cycling bipolar disorder, or current psychotic symptoms
  • Known sensitivity or contraindication to ketamine
  • Recent drug abuse
  • Pregnant
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01441505

Contacts
Contact: Angelo Alonzo 61 02 9382 3720 TMSandDCS@unsw.edu.au

Locations
Australia, New South Wales
Wesley Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Sponsors and Collaborators
The University of New South Wales
Wesley Hospital, Kogarah
Investigators
Principal Investigator: Colleen K Loo, MB BS FRANZCP MD University of New South Wales
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications:

Responsible Party: Colleen Loo, Associate Professor, The University of New South Wales
ClinicalTrials.gov Identifier: NCT01441505     History of Changes
Other Study ID Numbers: HREC 10409
Study First Received: September 16, 2011
Last Updated: February 20, 2013
Health Authority: Australia: Human Research Ethics Committee
Australia: National Health and Medical Research Council

Additional relevant MeSH terms:
Depression
Depressive Disorder
Depressive Disorder, Major
Behavioral Symptoms
Mood Disorders
Mental Disorders
Antidepressive Agents
Ketamine
Midazolam
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Anesthetics, Dissociative
Anesthetics, Intravenous
 Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Excitatory Amino Acid Antagonists
Excitatory Amino Acid Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Adjuvants, Anesthesia
Anti-Anxiety Agents
Tranquilizing Agents
Hypnotics and Sedatives

ClinicalTrials.gov processed this record on June 17, 2013