Phase 4
Completed N=96
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Source: ClinicalTrials.gov NCT00779506 ↗Enrolled (actual)
96
Serious AEs
0.0%
Results posted
Nov 2011
Primary outcomePrimary: The Change in Positive and Negative Syndrome Scale(PANSS)Total Score — -26.8 score on a scale
Summary
This is an 8-week, multi-centre, Open-label, non-comparative study to evaluate the efficacy and safety of Quetiapine XR with daily dose 400mg-800mg used as mono-therapy in the treatment of acute schizophrenic patients. The eligible patient will be assigned to study treatment with Quetiapine XR on Day 1.
PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Change in Positive and Negative Syndrome Scale(PANSS)Total Score |
-26.8 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Positive Score |
-7.4 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) Negative Score |
-6.2 | — |
| SECONDARY Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score |
-13.2 | — |
| SECONDARY Clinical Global Impression (CGI) Score |
-1.46 | — |
| SECONDARY Montgomery-Asberg Depression Rating Scale (MADRS) Total Score |
-9.44 | — |
| SECONDARY Global Assessment of Functioning (GAF) Score |
17.9 | — |
Eligibility Criteria
Inclusion Criteria
- Documented clinical diagnosis meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria
- PANSS total score of at least 70 at enrolment and at assignment Day 1
- CGI Severity of Illness score of at least 4 (moderately ill) at enrolment and at assignment Day 1 and with worsening of the patient's condition during the 3 weeks
Exclusion Criteria
- Known intolerance or lack of response to quetiapine fumarate
- Administration of a depot antipsychotic injection within one dosing interval (for the depot) before assignment
- Substance or alcohol dependence at enrolment
- Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment
Data sourced from ClinicalTrials.gov (NCT00779506). 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. Informational only — not medical advice.