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
Verified date | May 2011 |
Source | AstraZeneca |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Food and Drug Administration |
Study type | Interventional |
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).
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 |
Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Basic Science
Country | Name | City | State |
---|---|---|---|
United States | Research Site | New Haven | Connecticut |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
United States,
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 |
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