Back to resultsSeroquel XR in Adults With Schizophrenia
Primary Purpose
Schizophrenia
Status
Terminated
Phase
Phase 3
Locations
Thailand
Study Type
Interventional
Intervention
Quetiapine fumarate (Seroquel)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Quetiapine efficacy in schizophrenia
Eligibility 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
Sites / Locations
- Research Site
- Research Site
- Research Site
Outcomes
Primary Outcome Measures
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
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%.
Secondary Outcome Measures
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
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.
Clinical Global Impression - Severity of Illness (CGI-S) Score
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00852631
Brief Title
Seroquel XR in Adults With Schizophrenia
Official Title
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2012
Overall Recruitment Status
Terminated
Why Stopped
The study was prematurely terminated due to insufficient recruitment.
Study Start Date
February 2009 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Quetiapine efficacy in schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Quetiapine fumarate (Seroquel)
Other Intervention Name(s)
Seroquel XR
Intervention Description
600mg Extended release tablet, oral, once daily
Primary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Description
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%.
Time Frame
From Day 1 (baseline) to Day 42
Secondary Outcome Measure Information:
Title
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Description
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.
Time Frame
From Day 1 (Baseline) to Day 42
Title
Clinical Global Impression - Severity of Illness (CGI-S) Score
Description
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.
Time Frame
Day 14
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thawatchai Leelahanaj, MD
Organizational Affiliation
Phramongkutklao Hospital, Bangkok, Thailand
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Bangkok
Country
Thailand
Facility Name
Research Site
City
Chiang Mai
Country
Thailand
Facility Name
Research Site
City
Songkla
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Seroquel XR in Adults With Schizophrenia
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