Schizophrenia
Conditions
Brief summary
This study will evaluate the safety of multiple doses of NSA-789 in subjects with schizophrenia or schizoaffective disorder. This study will also assess how NSA-789 is absorbed and eliminated, and its effect, if any, on the brain.
Interventions
DRUGNSA-789
DRUGPlacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Inclusion: * Men or women of non childbearing potential (WONCBP) aged 18 to 50 years, inclusive. * Currently under the care of a physician for psychiatric illness. * Clinical diagnosis of schizophrenia or schizo affective disorder in the opinion of the study psychiatrist based on review of all available clinical data. Exclusion: * Any unstable medical or psychiatric condition, which may prevent the successful and safe completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety as measured by adverse events, monitoring of safety variables (ECGs, vital signs, laboratory test results) | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Tolerability as measured through the reporting of adverse events; Pharmacokinetic as measured by the concentrations of NSA-789 in blood; Pharmacodynamics as measured by the results of psychiatric ratings and neurologic evaluations. | 6 months |
Countries
United States
Outcome results
None listed