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

May 3, 2011 updated by: AstraZeneca

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 45 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 3
Placebo
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
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: 2
50 mg AD8529
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
fMRI
Time Frame: 3
3
Ketamine Infusion
Time Frame: 3
3

Secondary Outcome Measures

Outcome Measure
Positive and Negative Syndrome Scale (PANSS)
Clinician Administered Dissociative States Scale (CADSS)
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: John Krystal, Chair, Department of PsychiatryYale University School of MedicineChief of Psychiatry, Yale-New Haven Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (Actual)

April 1, 2011

Study Completion (Actual)

April 1, 2011

Study Registration Dates

First Submitted

September 25, 2009

First Submitted That Met QC Criteria

September 28, 2009

First Posted (Estimate)

September 29, 2009

Study Record Updates

Last Update Posted (Estimate)

May 4, 2011

Last Update Submitted That Met QC Criteria

May 3, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • D2285M00015

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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