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Completed

NCT Number: NCT00921804

Study to Assess the Efficacy, Safety, and Tolerability 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.

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Key information

Conditions

Schizophrenia Hallucinations Mental Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Paranoid Disorders Pathological Conditions, Signs and Symptoms Perceptual Disorders Schizophrenia Spectrum and Other Psychotic Disorders Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Garden Grove, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

AZD 8529

Drug

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

Risperidone

Drug

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

Other names: Risperdal

Placebo to match AZD8529

Drug

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

Placebo to match risperidone

Drug

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

Primary outcomes

  1. PANSS Total Score

    Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28

Secondary outcomes

  1. PANSS Positive, Negative, and General Psychopathology Subscale Scores

    Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28

  2. CGI-S

    Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28

  3. Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events

    Time frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 1, 8, 15, 22, and 28

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 16, 2009
Registry last updated
Jun 30, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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