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The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00985933
First received: September 25, 2009
Last updated: May 3, 2011
Last verified: May 2011
History of Changes

September 25, 2009
May 3, 2011
February 2010
April 2011   (final data collection date for primary outcome measure)
  • fMRI [ Time Frame: 3 ] [ Designated as safety issue: No ]
  • Ketamine Infusion [ Time Frame: 3 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00985933 on ClinicalTrials.gov Archive Site
  • Clinician Administered Dissociative States Scale (CADSS)
  • Positive and Negative Syndrome Scale (PANSS)
  • Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
A Single Center, Double-Blind, Randomized, Double Dummy, Placebo-Controlled, Three-Period Crossover Study to Assess the Effects of a mGluR2/3 Positive Allosteric Modulator [AZD8529] Upon Ketamine-Induced Cortical Stimulation and Impairment of Working-Memory Related Activation of the Prefrontal Cortex

The purpose of this study is to assess if ketamine will induce, in healthy volunteers, impairment of working memory and if the drug AZD8529 will block the effects of ketamine on working memory as assessed by functional magnetic resonance imaging (fMRI).
Not Provided
Interventional
Phase 0
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Basic Science
  • Healthy
  • Memory Impairment
  • Drug: AZD8529
    6 capsules by mouth 1 time 12 to 24 prior to assessments
  • Drug: Placebo to match AZD8529
    6 capsules by mouth 1 time 12 to 24 hours prior to assessments
  • Experimental: 1
    180 mg of AZD8529
    Interventions:
    • Drug: AZD8529
    • Drug: Placebo to match AZD8529
  • Experimental: 2
    50 mg AD8529
    Interventions:
    • Drug: AZD8529
    • Drug: Placebo to match AZD8529
  • Placebo Comparator: 3
    Placebo
    Interventions:
    • Drug: AZD8529
    • Drug: Placebo to match AZD8529
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
April 2011
April 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Right handed
  • 12th grade education or equivalent
  • Able to read and write English as primary language

Exclusion Criteria:

  • History of head injury
  • Substance abuse or dependence
  • History of claustrophobia
Both
21 Years to 45 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00985933
D2285M00015
Not Provided
MSD, AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: John Krystal Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
AstraZeneca
May 2011

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