Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
NCT ID: NCT00921804
Last Updated: 2010-06-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
296 participants
INTERVENTIONAL
2009-06-30
2010-05-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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1
AZD8529 40 mg
AZD 8529
40mg oral daily capsule administered as a single dose in the morning for 28 days
Placebo to match risperidone
Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
2
Placebo
Placebo to match AZD8529
Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidone
Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
3
Risperidone 4 mg (2mg on Day 1)
Risperidone
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529
Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Interventions
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AZD 8529
40mg oral daily capsule administered as a single dose in the morning for 28 days
Risperidone
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Placebo to match AZD8529
Placebo to match AZD8529 administered as a daily capsule in the morning for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Placebo to match risperidone
Placebo to match risperidone administered as a daily capsule in the evening for 28 days during the treatment period and also during the 3-7 day washout or run-in period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry
Exclusion Criteria
* Patients will be excluded if urine drug screen test show positive results
* Smoking of more than 2 packs of cigarettes a day
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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AstraZeneca
Principal Investigators
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Robert, Litman, M.D
Role: PRINCIPAL_INVESTIGATOR
CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850
Mark Smith
Role: STUDY_DIRECTOR
AstraZeneca1800 Concord PikeWilmington, DE, 19850
Locations
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Research Site
Garden Grove, California, United States
Research Site
Glendale, California, United States
Research Site
Rockville, Maryland, United States
Countries
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Other Identifiers
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D1960C00004
Identifier Type: -
Identifier Source: org_study_id