A Multi-Center Randomized, Placebo-Controlled, Double-Blind, Parallel Group, Phase IIb Proof of Concept Study With 3 Oral Groups of AZD3480 During 12 Weeks Treatment of Cognitive Deficits in Patients With Schizophrenia

AstraZeneca1 site in 1 country400 target enrollmentAugust 2007

ConditionsSchizophrenia

InterventionsAZD3480

DrugsAZD3480

Overview

Phase: Phase 2
Intervention: AZD3480
Conditions: Schizophrenia
Sponsor: AstraZeneca
Enrollment: 400
Locations: 1
Primary Endpoint: Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to demonstrate that AZD3480 improves cognition in patients with stable schizophrenia who are being treated with an atypical antipsychotic and who are active cigarette smokers, to assess the safety and tolerability of AZD3480 and to define the optimal dose(s) to be used in future trials.

Registry

clinicaltrials.gov

Start Date

August 2007

End Date

November 2008

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Eligibility Criteria

Inclusion Criteria

•Diagnosis of schizophrenia
•Outpatient at the time of screening and randomization
•Stable housing defined as having a place to live in the community (ie, not in a hospital or nursing home)
•Active cigarette smoking (10 or more cigarettes per day

Exclusion Criteria

•Any significant psychiatric or neurological disease other than schizophrenia, or current diagnosis of major depressive disorder
•Known or suspected drug or alcohol abuse within the 6 months or urine toxicology test positive for illegal or non-prescribed substances
•Impaired vision and/or hearing making cognitive testing difficult

Arms & Interventions

1

Placebo

Intervention: AZD3480

2

AZD3480 oral

Intervention: AZD3480

3

AZD3480 oral dose

Intervention: AZD3480

Outcomes

Primary Outcomes

Domain scores for Attention/Vigilance, Working Memory, Verbal Learning, Speed of Processing and Verbal Fluency as measured on the IntegNeuro computerized test battery of cognitive function

Time Frame: Change from baseline to Week 12