Safety and Efficacy of Seroquel in First Episode Schizophrenia

This study has been completed.

First Received: November 14, 2005 Last Updated: June 9, 2009 History of Changes

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00254241

Purpose

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

Condition	Intervention	Phase
Schizophrenia	Drug: Seroquel and Risperidone	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Efficacy Study
Official Title:	Safety and Efficacy of Seroquel in First Episode Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Risperidone Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	80
Study Start Date:	May 2002
Study Completion Date:	June 2006

Eligibility

Ages Eligible for Study:	18 Years to 35 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00254241

Locations

United Kingdom
Research Site
London, United Kingdom

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:

AstraZeneca Seroquel Medical Science Director, MD

AstraZenenca

More Information

No publications provided

Study ID Numbers:	BU-5077-0011
Study First Received:	November 14, 2005
Last Updated:	June 9, 2009
ClinicalTrials.gov Identifier:	NCT00254241 History of Changes
Health Authority:	United Kingdom: Department of Health

Keywords provided by AstraZeneca:

Schizophrenia

Study placed in the following topic categories:

Neurotransmitter Agents
Tranquilizing Agents
Risperidone
Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Serotonin

Schizophrenia
Quetiapine
Dopamine
Mental Disorders
Psychotic Disorders
Dopamine Agents
Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Neurotransmitter Agents
Tranquilizing Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Psychotropic Drugs
Risperidone
Central Nervous System Depressants
Dopamine Antagonists
Antipsychotic Agents
Pharmacologic Actions

Schizophrenia
Quetiapine
Serotonin Antagonists
Serotonin Agents
Mental Disorders
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 02, 2009