NCT00528905CompletedPhase 2
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
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 55 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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 Comparator
Placebo
Intervention: AZD3480 (Drug)
2
Experimental
AZD3480 oral
Intervention: AZD3480 (Drug)
3
Experimental
AZD3480 oral dose
Intervention: AZD3480 (Drug)
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
Secondary Outcomes
- UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS)(Change from baseline to Week 12)
Investigators
Study Sites (1)
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