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:	Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
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 ]

Estimated Enrollment:	100
Study Start Date:	February 2009
Estimated Study Completion Date:	June 2010

Intervention Details:

600mg Extended release tablet, oral, once daily

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

Contacts

Contact: AstraZeneca Thainland Clinical Study Information

66-2-7397400

sasarose.rochanaruangrai@astrazeneca.com

Locations

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

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:

Thawatchai Leelahanaj, MD

Phramongkutklao Hospital, Bangkok, Thailand

More Information

No publications provided

Responsible Party:	AstraZeneca (Thailand) Ltd. ( Pranee Krailadsiri, MD, PhD, Medical Director )
Study ID Numbers:	D1443L00060
Study First Received:	February 26, 2009
Last Updated:	January 7, 2010
ClinicalTrials.gov Identifier:	NCT00852631 History of Changes
Health Authority:	Thailand: Ethical Committee

Keywords provided by AstraZeneca:

Quetiapine efficacy in schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Quetiapine
Tranquilizing Agents
Mental Disorders
Therapeutic Uses
Physiological Effects of Drugs

Psychotropic Drugs
Central Nervous System Depressants
Antipsychotic Agents
Central Nervous System Agents
Pharmacologic Actions
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on February 08, 2010