Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.
 
ClinicalTrials.gov Identifier: NCT00985933
Recruitment Status : Completed
First Posted : September 29, 2009
Last Update Posted : May 4, 2011
Sponsor:
Information provided by:
AstraZeneca

Tracking Information
First Submitted Date  ICMJE September 25, 2009
First Posted Date  ICMJE September 29, 2009
Last Update Posted Date May 4, 2011
Study Start Date  ICMJE February 2010
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
  • fMRI [ Time Frame: 3 ]
  • Ketamine Infusion [ Time Frame: 3 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 28, 2009)
  • Clinician Administered Dissociative States Scale (CADSS)
  • Positive and Negative Syndrome Scale (PANSS)
  • Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Effects AZD8529 on Ketamine-induced Impairment of Working Memory in Healthy Volunteers
Official Title  ICMJE 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
Brief Summary 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).
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Condition  ICMJE
  • Healthy
  • Memory Impairment
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Estimated Enrollment  ICMJE
 (submitted: September 28, 2009)
20
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE April 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00985933
Other Study ID Numbers  ICMJE D2285M00015
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party MSD, AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: John Krystal Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital
PRS Account AstraZeneca
Verification Date May 2011

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