Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
- Registration Number
- NCT00779506
- Lead Sponsor
- AstraZeneca
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 96
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Quetiapine Fumarate XR Quetiapine Fumarate XR Seroquel XR 400-800mg
- Primary Outcome Measures
Name Time Method The Change in Positive and Negative Syndrome Scale(PANSS)Total Score From baseline to Day 57 PANSS, a 30-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme), total score is 30 - 210.
Description of the reporting Groups: Evaluate the efficacy of Quetiapine XR with daily dose 400 mg - 800 mg used as mono-therapy in the treatment of acute schizophrenic patients by evaluation of the change from baseline to Day 57 in total score of PANSS using the last observation carried forward (LOCF) method
- Secondary Outcome Measures
Name Time Method Positive and Negative Syndrome Scale (PANSS) Positive Score From baseline to Day 57 To evaluate the change of positive symptoms from baseline to Day 57 in PANSS positive score, a 7-item scale where eash symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Positive and Negative Syndrome Scale (PANSS) Negative Score From baseline to Day 57 To evaluate the change of negative symptoms from baseline to Day 57 in PANSS negative score, a 7-item scale where each symptom is rated on a severity scale ranging from 1 (absent) - 7 (extreme)
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score From baseline to Day 57 To evaluate the change of general psychopathology symptoms from baseline to Day 57 in PANSS general score, a 16-item scale where each symptom is rated on a severity scale ranging from 1 (absent) to - 7 (extreme)
Clinical Global Impression (CGI) Score From baseline to Day 57 The Clinical Global Impression - Severity (CGI-S) and - illness (CGI-I) is used in this study. The CGI-S is scored to rate the patient's current clinical state. The CGI-I is scored to rate the patient's change from baseline CGI. Each CGI item is scored on a scale from 1 to 7 (CGI-S: 1 = Normal, not ill, 7= Among the most extremely ill patients/ CGI-I: 1= very much improved, 7= very much worse). CGI-I scores greater than 4 indicate worsening, while scores less than 4 indicate improvement
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score From baseline to Day 57 To treat depressive symptoms in acute schizophrenic patients by evaluation of the change from baseline to day 67 in MADRS total score, a 10-item scale for the evaluation of depressive symptoms. Each MADRS item is rated on a 0-6 scale, higher MADRS scores indicate higher levels of depressive symptoms.
Global Assessment of Functioning (GAF) Score From baseline to Day 57 To improve functional capability in acute schizophrenic patients by evaluation of the change from baseline to Day 57 in GAF scale score, a single-item rating scale for evaluating the overall functioning on a continuum from psychologic or psychiatric sickness to health.
Trial Locations
- Locations (1)
Research site
🇰🇷Seoul, Korea, Republic of