Back to resultsThe Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
AZD8529
Placebo to match AZD8529
Sponsored by
About this trial
This is an interventional basic science trial for Schizophrenia focused on measuring schizophrenia, early phase trials
Eligibility Criteria
Inclusion Criteria:
- DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
- ECT in the last 6 months
- Substance abuse or dependence
- History of claustrophobia
Sites / Locations
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
1
2
Arm Description
80 mg AZD8529
Placebo
Outcomes
Primary Outcome Measures
Functional magnetic resonance imaging (fMRI)
Computerized neurocognitive tests
Secondary Outcome Measures
Positive and Negative Syndrome Scale (PANSS)
Electroencephalography (EEG)
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,
Suicidality assessment, collection of adverse events
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00986531
Brief Title
The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
Official Title
A Single Center, Double-Blind, Randomized, Placebo-Controlled, Two-Period Crossover Study to Access an Early Signal of Efficacy for Cognition and Negative Symptoms With AZD8529 in Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2011
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
October 2011 (Actual)
Study Completion Date
October 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to assess if AZD8529 improves performance on neurobehavioral probes of attention, working memory and affective reactivity in patients with schizophrenia.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
schizophrenia, early phase trials
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
59 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
80 mg AZD8529
Arm Title
2
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AZD8529
Intervention Description
2 capsules by mouth for 3 days
Intervention Type
Drug
Intervention Name(s)
Placebo to match AZD8529
Intervention Description
2 capsules by mouth for 3 days
Primary Outcome Measure Information:
Title
Functional magnetic resonance imaging (fMRI)
Time Frame
1 fMRI on Day 4; 1 fMRI on Day 21
Title
Computerized neurocognitive tests
Time Frame
1 on Day -1; 1 on Day 1 and on Day 21
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS)
Time Frame
Day-1; Day 4; Day 17; Day 21
Title
Electroencephalography (EEG)
Time Frame
Day 4; Day 21
Title
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,
Time Frame
Labs at screening and on Days -1, 4, 17, 21, and 35; ECG at screening and Day 35; Physical Exam at screening and Day 35; Vital signs at screening and Days -1,4, 17, 21, and 35
Title
Suicidality assessment, collection of adverse events
Time Frame
Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
DSM-IV diagnosis of schizophrenia or schizoaffective disorder
Exclusion Criteria:
ECT in the last 6 months
Substance abuse or dependence
History of claustrophobia
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel Gur
Organizational Affiliation
Hospital of the University of Pennsylvania, Dept of Psychiatry, Neuropsychiatry Section
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Philadelphia
State/Province
Pennsylvania
Country
United States
12. IPD Sharing Statement
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The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics
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