Back to resultsStudy to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AZD 8529
Risperidone
Placebo to match AZD8529
Placebo to match risperidone
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Placebo Comparator
Other
Arm Label
1
2
3
Arm Description
AZD8529 40 mg
Placebo
Risperidone 4 mg (2mg on Day 1)
Outcomes
Primary Outcome Measures
PANSS Total Score
Secondary Outcome Measures
PANSS Positive, Negative, and General Psychopathology Subscale Scores
CGI-S
Vital signs measurements, body weight, physical exam, clinical laboratory evaluations, ECGs, Extrapyramidal Symptoms, suicidal symptoms, cognition and incidence of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00921804
Brief Title
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2010
Overall Recruitment Status
Completed
Study Start Date
June 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Hallucinations, Paranoia, Inpatient schizophrenia clinical trial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
296 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
AZD8529 40 mg
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
3
Arm Type
Other
Arm Description
Risperidone 4 mg (2mg on Day 1)
Intervention Type
Drug
Intervention Name(s)
AZD 8529
Intervention Description
40mg oral daily capsule administered as a single dose in the morning for 28 days
Intervention Type
Drug
Intervention Name(s)
Risperidone
Other Intervention Name(s)
Risperdal
Intervention Description
4mg (2mg on Day 1) oral daily capsule administered as a single dose in the evening for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo to match AZD8529
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo to match risperidone
Intervention Description
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 Outcome Measure Information:
Title
PANSS Total Score
Time Frame
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Secondary Outcome Measure Information:
Title
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
Title
CGI-S
Time Frame
Prior to randomization (screening, admission to washout/run in, baseline) and Days 8, 15, 22, and 28
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert, Litman, M.D
Organizational Affiliation
CBH Health9605 Medical Center Drive Suite 270Rockville, MD, 20850
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Smith
Organizational Affiliation
AstraZeneca1800 Concord PikeWilmington, DE, 19850
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Garden Grove
State/Province
California
Country
United States
Facility Name
Research Site
City
Glendale
State/Province
California
Country
United States
Facility Name
Research Site
City
Rockville
State/Province
Maryland
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Study to Assess the Efficacy, Safety, and Tolerability of AZD8529 in Adult Schizophrenia Patients
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