Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia
Intervention: Quetiapine Fumarate XR (Drug)
Phase: Phase 4
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
YounHoon Kim, Principal Investigator, Affiliation: Inje University Pusan Paik Hospital
Overall contact:
AstraZeneca Korea Clinical Study, Information, Phone: 82 2 2188 0800
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 (total psychiatric history between 1 month and 5 years). 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.
Clinical Details
Official title: A 8-Week, Multi-Centre, Open-Label, Non-Comparative, Phase IV Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) With Daily Dose 400mg-800mg in the Treatment of Acute Schizophrenic Patients
Study design: Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study
Primary outcome: Change in PANSS total score
Secondary outcome: Change in PANSS positive scale scoreChange in PANSS negative scale score Change in PANSS general psychopathology score
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
AstraZeneca Korea Clinical Study, Information, Phone: 82 2 2188 0800
Research site, Pusan, Korea, Republic of
Research site, Seoul, Korea, Republic of
Research site, Naju, Korea, Republic of
Research site, Incheon, Korea, Republic of
Research site, Ansan, Gyeonggi-do, Korea, Republic of
Research site, Gwangju, Gyeonggi-do, Korea, Republic of
Research site, Bugok, Gyeongsangnam-do, Korea, Republic of
Research site, Masan, Gyeongsangnam-do, Korea, Republic of
Additional Information
Starting date: October 2008
Ending date: August 2009
Last updated: December 19, 2008
|
