Schizophrenia
Conditions
Keywords
Schizophrenia
Brief summary
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia
Interventions
DRUGSeroquel and Risperidone
Sponsors
AstraZeneca
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 35 Years
Healthy volunteers
No
Inclusion criteria
* Age 18-35 years Meet ICD-10 criteria for schizophrenia No abnormaility on clinical examination No previous episode of psychosis No previous antipsychotics of any kind in last 3 months
Exclusion criteria
* Have received a course of antipsychotics drug treatment prior to entry which may introduce risk factors or interfere with study procedures Have received anticholinergics within 10 days of baseline aseessment Have received mood stabilizers or anti depressants within 2 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment | — |
Secondary
| Measure | Time frame |
|---|---|
| CGI global improvement | — |
| PANSS total score and subscales) | — |
| Abnormal Involuntary Movement Scale (AIMS) | — |
| CGI severity of illness | — |
| Serum prolactin levels | — |
| Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects | — |
| Proportion of patients experiencing relapse. | — |
| Dose of anti cholinergic medication | — |
Countries
United Kingdom
Outcome results
None listed