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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Schizophrenia

Treatments: Drug: Risperidone; Drug: AZD 8529; Drug: Placebo to match AZD8529; Drug: Placebo to match risperidone

Study type: Interventional

Funder types: Industry

Identifiers

NCT00921804

D1960C00004

Details and patient eligibility

About

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.

Enrollment: 296 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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296 participants in 3 patient groups, including a placebo group

1

Experimental group

Description:

AZD8529 40 mg

Treatment:

Drug: Placebo to match risperidone

Drug: AZD 8529

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo to match risperidone

Drug: Placebo to match AZD8529

3

Other group

Description:

Risperidone 4 mg (2mg on Day 1)

Treatment:

Drug: Placebo to match AZD8529

Drug: Risperidone