Schizophrenia
Conditions
Brief summary
The objective of this study is to evaluate the safety, tolerability, and efficacy of two dose regimens of PF-3463275 compared with placebo added to ongoing atypical antipsychotic therapy for cognitive deficits in subjects with chronic symptoms of schizophrenia.
Interventions
DRUGPF-3463275
PF-3463275 10mg
DRUGPlacebo
Placebo
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of schizophrenia * In stable treatment with risperidone, olanzapine, quetiapine, ziprasidone, aripiprazole, or paliperidone for at least 2 months * Stable symptoms of schizophrenia for at least 3 months.
Exclusion criteria
* Subjects with a psychiatric disorder other than schizophrenia * Substance dependence or abuse * Women who have child bearing potential.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in the CNS Vital Signs Cognition Battery composite score | 6 days |
| Safety Endpoints: tolerability, laboratory tests, vital signs, and ECG's. | 38 days |
| Pharmacokinetics of PF-3463275 | 6 days |
Secondary
| Measure | Time frame |
|---|---|
| Positive and Negative Syndrome Scale (PANSS) | 6 days |
| Change from baseline in the CNS Vital Signs Cognition Battery domain scores | 6 days |
Countries
United States
Outcome results
None listed