Study Stopped
The study was prematurely terminated due to insufficient recruitment.
Seroquel XR in Adults With Schizophrenia
Open-label Multicentre Study on Efficacy and Safety of Oral Quetiapine (Seroquel XR) in Adults With Schizophrenia
1 other identifier
interventional
28
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3 schizophrenia
Started Feb 2009
Shorter than P25 for phase_3 schizophrenia
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2009
CompletedFirst Submitted
Initial submission to the registry
February 26, 2009
CompletedFirst Posted
Study publicly available on registry
February 27, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2010
CompletedResults Posted
Study results publicly available
July 17, 2012
CompletedJuly 17, 2012
May 1, 2012
1.2 years
February 26, 2009
May 18, 2011
June 12, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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%.
From Day 1 (baseline) to Day 42
Secondary Outcomes (2)
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
From Day 1 (Baseline) to Day 42
Clinical Global Impression - Severity of Illness (CGI-S) Score
Day 14
Interventions
600mg Extended release tablet, oral, once daily
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (3)
Research Site
Bangkok, Thailand
Research Site
Chiang Mai, Thailand
Research Site
Songkhla, Thailand
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Thawatchai Leelahanaj, MD
Phramongkutklao Hospital, Bangkok, Thailand
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 26, 2009
First Posted
February 27, 2009
Study Start
February 1, 2009
Primary Completion
May 1, 2010
Study Completion
May 1, 2010
Last Updated
July 17, 2012
Results First Posted
July 17, 2012
Record last verified: 2012-05