Safety and Efficacy of Seroquel in First Episode Schizophrenia

Phase 4CompletedNCT00254241

AstraZeneca80 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Schizophrenia

Interventions

Seroquel and RisperidoneDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 35 Years

Medical Language ↔ Plain English

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

Locations (1)

Research Site

London, United Kingdom

Outcomes

Primary Outcomes

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

Secondary Outcomes

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.

Data from ClinicalTrials.gov

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