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

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia
• Intervention / Treatment: Drug: AZD 8529; Drug: Placebo to match risperidone; Drug: Placebo to match AZD8529; Drug: Risperidone

• Study Type: Interventional
• Enrollment (Actual): 296
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • California
    • Garden Grove, California, United States
      • Research Site
    • Glendale, California, United States
      • Research Site
  • Maryland
    • Rockville, Maryland, United States
      • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: 2; Placebo	Drug: 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; Drug: 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
Experimental: 1; AZD8529 40 mg	Drug: AZD 8529; 40mg oral daily capsule administered as a single dose in the morning for 28 days; Drug: 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: 3; Risperidone 4 mg (2mg on Day 1)	Drug: 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; Drug: Risperidone; 4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days; Other Names: Risperdal

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Robert, Litman, M.D, CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850; Study Director: Mark Smith, AstraZeneca1800 Concord PikeWilmington, DE, 19850

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Actual): May 1, 2010
• Study Completion (Actual): May 1, 2010

Study Registration Dates

• First Submitted: June 12, 2009
• First Submitted That Met QC Criteria: June 15, 2009
• First Posted (Estimate): June 16, 2009

Study Record Updates

• Last Update Posted (Estimate): June 30, 2010
• Last Update Submitted That Met QC Criteria: June 29, 2010
• Last Verified: June 1, 2010

More Information

Terms related to this study

• Keywords: Schizophrenia; Hallucinations; Paranoia; Inpatient schizophrenia clinical trial
• Additional Relevant MeSH Terms: Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders; Schizophrenia; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Serotonin Agents; Dopamine Agents; Serotonin Antagonists; Dopamine Antagonists; Risperidone
• Other Study ID Numbers: D1960C00004