Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
The purpose of this study is to determine whether a low dose and a high dose of the study drug SCA-136 are effective and safe in the treatment of schizophrenia requiring hospitalization.
Interventions
DRUGSCA-136 (200 mg)
DRUGSCA-136 (400 mg)
DRUGolanzapine (15 mg)
DRUGplacebo
Sponsors
Wyeth is now a wholly owned subsidiary of Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of schizophrenia * Ability to remain hospitalized for at least first 4 weeks of study * Needs hospitalization due to worsening of schizophrenia
Exclusion criteria
* Type 1 or 2 diabetes * Previous use of clozapine * Serious medical illness other than schizophrenia
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline to day 42 on the positive subscale of the SCI-PANNS | — |
Secondary
| Measure | Time frame |
|---|---|
| SCI-PANNS total score | — |
| negative symptom sub-scale score of SCI-PANNS | — |
| general psychopathology subscale score of SCI-PANNS | — |
| response rate based upon SCI-PANNS total score | — |
| Change from baseline to day 42 on: | — |
| CGI-S score | — |
| CGI-I score | — |
| Cognitive assessments scores | — |
| BPRS score | — |
Countries
United States
Outcome results
None listed