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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00985933
• Other study ID #: D2285M00015
• Status: Completed
• Phase: Phase 0
• First received: September 25, 2009
• Last updated: May 3, 2011
• Start date: February 2010
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 21 Years to 45 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy
• Memory Impairment

Intervention

Drug:
• AZD8529
6 capsules by mouth 1 time 12 to 24 prior to assessments
• Placebo to match AZD8529
6 capsules by mouth 1 time 12 to 24 hours prior to assessments

Locations

Country	Name	City	State
United States	Research Site	New Haven	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	fMRI		3	No
Primary	Ketamine Infusion		3	No
Secondary	Clinician Administered Dissociative States Scale (CADSS)
Secondary	Positive and Negative Syndrome Scale (PANSS)
Secondary	Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs, collection of adverse events			Yes