Seroquel XR in Adults With Schizophrenia - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00852631

Purpose

The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.

Condition	Intervention	Phase
Schizophrenia	Drug: Quetiapine fumarate (Seroquel)	Phase III

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

Drug Information available for: Quetiapine Quetiapine fumarate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in PANSS total score from baseline (day 1) to final visit (day 42) [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]
Recording of adverse events [ Time Frame: Throughout the study ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in PANSS total score from baseline to each post-baseline visit [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]
Change in CGI assessment [ Time Frame: At screening, day 1, day 14 and day 42 ] [ Designated as safety issue: No ]

Enrollment:	28
Study Start Date:	February 2009
Study Completion Date:	May 2010

Intervention Details:

600mg Extended release tablet, oral, once daily

Other Name: Seroquel XR

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Patient meets the DSM-IV criteria for schizophrenia
Patient has a PANSS total score ≥ 70 at baseline
Patient has a CGI-S score of ≥ 4(moderately ill) at baseline
Patient is healthy on the basis of physical examination and vital signs at baseline

Exclusion Criteria:

Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse
Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen
Patient with unstable or inadequately treated Diabetes Mellitus
Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00852631

Locations

Thailand
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Songkla, Thailand

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Thawatchai Leelahanaj, MD

Phramongkutklao Hospital, Bangkok, Thailand

More Information

No publications provided

Responsible Party:	Sompob Paibulsirijit, Medical Director, AstraZeneca (Thailand) Ltd.
ClinicalTrials.gov Identifier:	NCT00852631 History of Changes
Other Study ID Numbers:	D1443L00060
Study First Received:	February 26, 2009
Last Updated:	July 19, 2010
Health Authority:	Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Quetiapine efficacy in schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Schizophrenia and Disorders with Psychotic Features
Mental Disorders
Quetiapine
Antipsychotic Agents
Tranquilizing Agents

Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Psychotropic Drugs

ClinicalTrials.gov processed this record on February 09, 2012