Seroquel XR in Adults With Schizophrenia

June 12, 2012 updated by: AstraZeneca

Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia

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.

Study Overview

Status

Terminated

Conditions

Schizophrenia

Intervention / Treatment

Drug: Quetiapine fumarate (Seroquel)

Study Type

Interventional

Enrollment (Actual)

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Positive and Negative Syndrome Scale (PANSS) Total Score Time Frame: From Day 1 (baseline) to Day 42	Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.	From Day 1 (baseline) to Day 42

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score Time Frame: From Day 1 (Baseline) to Day 42	Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.	From Day 1 (Baseline) to Day 42
Clinical Global Impression - Severity of Illness (CGI-S) Score Time Frame: Day 14	Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline > 1 score.	Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

Principal Investigator: Thawatchai Leelahanaj, MD, Phramongkutklao Hospital, Bangkok, Thailand

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

May 1, 2010

Study Completion (Actual)

May 1, 2010

Study Registration Dates

First Submitted

February 26, 2009

First Submitted That Met QC Criteria