The Effects AZD8529 on Cognition and Negative Symptoms in Schizophrenics

Phase 1

Completed

• Conditions: Schizophrenia
• Interventions: Drug: Placebo to match AZD8529; Drug: AZD8529

• Registration Number: NCT00986531
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2009-09-29
• Study First Submitted QC: 2009-09-29
• Study First Posted: 2009-09-30
• Study Start: 2009-11
• Status Verified: 2011-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Last Update Submitted: 2011-10-31
• Last Update Posted: 2011-11-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo to match AZD8529	Placebo
1	AZD8529	80 mg AZD8529

Primary Outcome Measures

Name	Time	Method
Functional magnetic resonance imaging (fMRI)	1 fMRI on Day 4; 1 fMRI on Day 21
Computerized neurocognitive tests	1 on Day -1; 1 on Day 1 and on Day 21

Secondary Outcome Measures

Name	Time	Method
Positive and Negative Syndrome Scale (PANSS)	Day-1; Day 4; Day 17; Day 21
Electroencephalography (EEG)	Day 4; Day 21
Laboratory assessment: electrocardiogram (ECG), physical exam, vital signs,	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
Suicidality assessment, collection of adverse events	Suicidality assesment at screening; and Days -1, 4, 17, 21, and 35 Adverse events at screening, and Days -1,4,17,21, and 35

Trial Locations

Locations (1)

Research Site; 🇺🇸 Philadelphia, Pennsylvania, United States