Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients

Phase 2

Completed

• Conditions: Schizophrenia
• Interventions: Drug: AZD 8529; Drug: Risperidone; Drug: Placebo to match AZD8529; Drug: Placebo to match risperidone

• Registration Number: NCT00921804
• Lead Sponsor: AstraZeneca

Brief Summary

The purpose of this study is to determine whether treatment with daily oral dose of AZD8529 40 mg administered over 28 days is safe, well tolerated and improves main symptoms of schizophrenia in adult schizophrenia patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-12
• Study First Submitted QC: 2009-06-15
• Study First Posted: 2009-06-16
• Primary Completion: 2010-05
• Study Completion: 2010-05
• Status Verified: 2010-06
• Last Update Submitted: 2010-06-29
• Last Update Posted: 2010-06-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 296

Inclusion Criteria

• Patient will need to read, understand and sign an informed consent prior to any study specific procedures
• Patient will have certain schizophrenia symptoms deemed by the investigator as appropriate for the study entry

Exclusion Criteria

• Patients will be excluded based on recent history of significant illness or current disease as assessed by the investigator during screening process (based on physical examination, laboratory studies and electrocardiogram studies)
• Patients will be excluded if urine drug screen test show positive results
• Smoking of more than 2 packs of cigarettes a day

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD 8529	AZD8529 40 mg
3	Risperidone	Risperidone 4 mg (2mg on Day 1)
1	Placebo to match risperidone	AZD8529 40 mg
2	Placebo to match AZD8529	Placebo
2	Placebo to match risperidone	Placebo
3	Placebo to match AZD8529	Risperidone 4 mg (2mg on Day 1)

Primary Outcome Measures

Name	Time	Method
PANSS Total Score	Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28

Secondary Outcome Measures

Name	Time	Method
PANSS Positive, Negative, and General Psychopathology Subscale Scores	Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
CGI-S	Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events	Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28

Trial Locations

Locations (1)

Research Site; 🇺🇸 Rockville, Maryland, United States