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

NCT00921804 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 296

Last updated 2010-06-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

AZD 8529

40mg oral daily capsule administered as a single dose in the morning for 28 days

DRUG

Risperidone

4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days

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

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

Sponsors & Collaborators

Principal Investigators

  • Robert, Litman, M.D · CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850

  • Mark Smith · AstraZeneca1800 Concord PikeWilmington, DE, 19850

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-06-30
Primary Completion
2010-05-31
Completion
2010-05-31

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00921804 on ClinicalTrials.gov