Schizophrenia
Conditions
Keywords
Schizophrenia, Cognitive Deficits
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.
Interventions
DRUGAZD3480
oral capsule
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| UCSD Performance Based Skills Assessment (UPSA2) and on the Social Functioning Scale (SFS) | Change from baseline to Week 12 |
Countries
Canada, United States
Outcome results
None listed