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

Study Overview
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Brief Summary
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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.

Official Title
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A Phase IIa, Double-blind, Double-Dummy, Placebo-controlled, Active-controlled, Randomized, Parallel-Group Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of AZD8529 in Adult Schizophrenia Patients

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: AZD 8529
* Drug: Risperidone
* Drug: Placebo to match AZD8529
* Drug: Placebo to match risperidone


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>AZD8529 40 mg | Drug: AZD 8529<br>* 40mg oral daily capsule administered as a single dose in the morning for 28 days<br>Drug: Placebo to match risperidone<br>* 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<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Placebo to match AZD8529<br>* 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<br>Drug: Placebo to match risperidone<br>* 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<br>|
| Other: 3<br>Risperidone 4 mg (2mg on Day 1) | Drug: Risperidone<br>* 4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days<br>* Other names: Risperdal;Drug: Placebo to match AZD8529<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS Total Score |  | Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial