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

NCT00921804 | Completed Phase 2

• 1 other identifier: D1960C00004
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 3

Brief 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

Schizophrenia

Keywords

Schizophrenia; Hallucinations; Paranoia; Inpatient schizophrenia clinical trial

Outcome Measures

Primary Outcomes (1)

• PANSS Total Score

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

Secondary Outcomes (3)

• 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

Study Arms (3)

1

EXPERIMENTAL

AZD8529 40 mg

Drug: AZD 8529; Drug: Placebo to match risperidone

2

PLACEBO COMPARATOR

Placebo

Drug: Placebo to match AZD8529; Drug: Placebo to match risperidone

3

OTHER

Risperidone 4 mg (2mg on Day 1)

Drug: Risperidone; Drug: Placebo to match AZD8529

Interventions

AZD 8529 DRUG

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

1

Risperidone DRUG

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

Also known as: Risperdal

3

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

2; 3

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

1; 2

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (3)

Research Site

Garden Grove, California, United States

Location

Research Site

Glendale, California, United States

Location

Research Site

Rockville, Maryland, United States

Location

MeSH Terms

Conditions

Schizophrenia; Hallucinations; Paranoid Disorders

Interventions

Risperidone

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Pyrimidinones; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Robert, Litman, M.D

  CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850

  PRINCIPAL INVESTIGATOR

• Mark Smith

  AstraZeneca1800 Concord PikeWilmington, DE, 19850

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: June 12, 2009
• First Posted: June 16, 2009
• Study Start: June 1, 2009
• Primary Completion: May 1, 2010
• Study Completion: May 1, 2010
• Last Updated: June 30, 2010

Record last verified: 2010-06

Locations

US (3)