Safety and Efficacy of Seroquel in First Episode Schizophrenia

Condition(s) targeted: Schizophrenia

Intervention: Seroquel and Risperidone (Drug)

Phase: Phase 3

Status: No longer recruiting

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
AstraZeneca Seroquel Medical Science Director, MD, Study Director, Affiliation: AstraZenenca

To compare the safety, tolerability and efficacy of Seroquel and risperidone in first episode schizophrenia

Official title: Safety and Efficacy of Seroquel in First Episode Schizophrenia

Study design: Interventional, Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: The proportion of patients developing clinically significant EPS at any point between baseline (day 1) and final assessment

Secondary outcome:

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.

Minimum age: 18 Years. Maximum age: 35 Years. Gender(s): Both.

Criteria:

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

Research Site, London, United Kingdom

Starting date: May 2002
Last updated: November 21, 2006