Phase 3
N=388
Efficacy and Safety of Quetiapine Fumarate in the Treatment of Schizophrenic Patients
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00882518 ↗Enrolled (actual)
388
Serious AEs
0.5%
Results posted
May 2012
Primary outcome: Primary: Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42 — -33.4; -35.9 scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Quetiapine Fumarate (SEROQUEL) Extended-Release (XR) (Drug); Chlorpromazine (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Jul 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline of the Positive and Negative Syndrome Scale (PANSS) Total Score at the End of Treatment at Day 42 |
-33.4; -35.9 | — |
| SECONDARY Change From Baseline in PANSS Positive Subscale Score at the End of Treatment at Day 42 |
-9.9; -11.1 | — |
| SECONDARY Change From Baseline in PANSS Negative Subscale Score at the End of Treatment at Day 42 |
-5.9; -6.7 | — |
| SECONDARY Change From Baseline in PANSS General Psychopathological Subscale Score at the End of Treatment at Day 42 |
-12.9; -13.9 | — |
| SECONDARY Change From Baseline in PANSS Aggression, Hostility Clusters Score at the End of Treatment at Day 42 |
-4.8; -5.4 | — |
| SECONDARY Change From Baseline in PANSS Depression Clusters Score at the End of Treatment at Day 42 |
-1.8; -1.7 | — |
| SECONDARY Number of Patients Achieving a Reduction of at Least 30% From Baseline PANSS Total Score at the End of Treatment at Day 42 |
57.7; 66.3 | — |
| SECONDARY Percentage of Patients With Clinical Global Impression (CGI) Global Improvement Rating Less Than or Equal to 3 at the End of Treatment at Day 42 |
87.6; 88.9 | — |
| SECONDARY Change in the CGI Severity of Illness Score From Baseline at the End of Treatment at Day 42 |
-1.8; -2.1 | — |
Summary
The primary objective of this study is to evaluate the efficacy of quetiapine fumarate extended-release (XR) used as mono-therapy, administered once daily, in the treatment of schizophrenic patient with acute episode.
Eligibility Criteria
Inclusion Criteria
- Schizophrenia diagnosis
- Provision of written informed consent before initiation of any study
Exclusion Criteria
- AIDS and hepatitis B
- History of seizure disorder
- Hospitalisation for schizophrenic more than 1 month immediately before enter into study
Data sourced from ClinicalTrials.gov (NCT00882518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.