Safety and Efficacy of Seroquel in First Episode Schizophrenia
Phase 4
Completed
- Conditions
- Schizophrenia
- Registration Number
- NCT00254241
- Lead Sponsor
- AstraZeneca
- Brief Summary
To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment
- Secondary Outcome Measures
Name Time Method CGI severity of illness CGI global improvement PANSS total score and subscales) Abnormal Involuntary Movement Scale (AIMS) Dose of anti cholinergic medication Serum prolactin levels Proportion of patients discontinuing treatment due to reasons of lack of efficacy or adverse effects Proportion of patients experiencing relapse.
Trial Locations
- Locations (1)
Research Site
🇬🇧London, United Kingdom