Phase 4
N=35
Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia
Schizophrenia
Bottom Line
View on ClinicalTrials.gov: NCT00954122 ↗Enrolled (actual)
35
Serious AEs
2.9%
Results posted
Jan 2013
Primary outcome: Primary: Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score — -7.5 Scores on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Quetiapine XR (Seroquel XR) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score |
-7.5 | — |
| SECONDARY Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores. |
-9.3 | — |
| SECONDARY Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores |
-5.7 | — |
| SECONDARY Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score |
-33.2 | — |
| SECONDARY Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S) |
-1.2 | — |
| SECONDARY Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale |
3.9; 2.4 | — |
| SECONDARY Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21. |
-33.2 | — |
Summary
The purpose of the study is to determine whether treatment with quetiapine XR (Seroquel XR) tablets for 3 weeks will improve their agitation when they have acute psychosis.
Eligibility Criteria
Inclusion Criteria
- Requirement for treatment of acute episode of schizophrenia (according to DSM-IV diagnostic criteria)
- PANSS total score of ³ 75
- CGI > 4
Exclusion Criteria
- Any DSM-IV (Diagnostic and Statistical Manual of Mental Disorders 4th Edition) Axis I disorder not defined in the inclusion criteria
- Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others
- Substance or alcohol dependence at enrollment
Data sourced from ClinicalTrials.gov (NCT00954122). 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.