Dose Finding of Quetiapine Fumarate 200mg vs 400mg in First Episode Psychosis - Full Text View

Purpose

The purpose of this study is determine the minimal effective dose and the impact on:

treatment outcomes at 4, 12 and/or 48 weeks the treatment has required to treat patients experiencing the first psychotic episode
the final maintenance doses
the use of other medications
the amount of changes to other antipsychotic medication
the number of hospitalization days

Condition	Intervention	Phase
Psychosis	Drug: Quetiapine Fumarate	Phase IV

MedlinePlus related topics:

Psychotic Disorders

Drug Information available for:

Quetiapine Quetiapine fumarate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Dose Comparison, Single Group Assignment, Safety/Efficacy Study

Official Title:	A Naturalistic, Prospective, Single Centre, Double Blinded, Fixed Dose, Randomised, Four Week Comparison Study Investigating Efficacy, Tolerability and Safety of 200 mg Per Day Versus 400 mg Per Day Quetiapine Fumarate in 200 Drug naïve First Episode Psychosis Patients Aged 15 to 25 Years.

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Medication dose, Remission and response rate, exBPRSvs4, SANS, CGI – I, CGI – S, CDSS, GAF and QoL scale

Secondary Outcome Measures:

SWN, UKU, illicit substance use, laboratory measures, altered drop-out rates

Estimated Enrollment:	150
Study Start Date:	July 2003

Eligibility

Ages Eligible for Study:	15 Years to 25 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Patients experiencing their first psychotic episode
Male or Female
Aged 15-25

Exclusion Criteria:

Previous treatment with antipsychotic medication (longer than 1 week)
History of a clinically significant physical illness
Organic disorder presenting with psychotic symptoms

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00449397

Locations


Australia
	Research Sites
	Melbourne, Australia

Sponsors and Collaborators

AstraZeneca

Investigators


Principal Investigator:	Gregor Berger, MD	ORYGEN Research Centre/ ORYGEN Youth Health

More Information

Study ID Numbers:	AU-SEA-003
First Received:	March 19, 2007
Last Updated:	March 19, 2007
ClinicalTrials.gov Identifier:	NCT00449397
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by AstraZeneca:

First Episode Psychosis

Study placed in the following topic categories:

Schizophrenia

Signs and Symptoms

Quetiapine

Mental Disorders

Psychotic Disorders

Schizophrenia and Disorders with Psychotic Features

Additional relevant MeSH terms:

Tranquilizing Agents

Therapeutic Uses

Physiological Effects of Drugs

Psychotropic Drugs

Central Nervous System Depressants

Antipsychotic Agents

Central Nervous System Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00449397