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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00985933
Other study ID # D2285M00015
Secondary ID
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


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
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