Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: AZD 8529 Drug: Risperidone Drug: Placebo to match AZD8529 Drug: Placebo to match risperidone	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

PANSS Total Score [ Time Frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
CGI-S [ Time Frame: Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]

Enrollment:	296
Study Start Date:	June 2009
Study Completion Date:	May 2010
Primary Completion Date:	May 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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
Placebo Comparator: 2 Placebo	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
3 Risperidone 4 mg (2mg on Day 1)	Drug: Risperidone 4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days Other Name: Risperdal 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

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00921804

Locations

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

Sponsors and Collaborators

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

More Information

No publications provided

Responsible Party:	MSD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00921804 History of Changes
Other Study ID Numbers:	D1960C00004
Study First Received:	June 12, 2009
Last Updated:	June 29, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by AstraZeneca:

Schizophrenia
Hallucinations
Paranoia
Inpatient schizophrenia clinical trial

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on June 17, 2013