Safety and Efficacy of Seroquel in First Episode Schizophrenia

This study has been completed.

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

Sponsor:	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 4

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind Primary Purpose: Treatment
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

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

Keywords provided by AstraZeneca:

Schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Risperidone
Quetiapine
Serotonin Antagonists
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

Physiological Effects of Drugs
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs
Dopamine Antagonists
Dopamine Agents

ClinicalTrials.gov processed this record on May 21, 2012