Proof of Concept Study of Cognitive Improvement in Patients With Schizophrenia
Phase 2
Completed
- Conditions
- Schizophrenia
- Interventions
- Drug: AZD3480
- Registration Number
- NCT00528905
- Lead Sponsor
- AstraZeneca
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 400
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
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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
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 AZD3480 Placebo 2 AZD3480 AZD3480 oral 3 AZD3480 AZD3480 oral dose
- Primary Outcome Measures
Name Time Method 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 Change from baseline to Week 12
- Secondary Outcome Measures
Name Time Method UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) Change from baseline to Week 12
Trial Locations
- Locations (1)
Research Site
🇨🇦Montreal, Quebec, Canada