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Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)

Information source: AstraZeneca
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Schizophrenia

Intervention: Quetiapine Fumarate XR (Drug)

Phase: Phase 4

Status: Completed

Sponsored by: AstraZeneca

Official(s) and/or principal investigator(s):
YounHoon Kim, Principal Investigator, Affiliation: Inje University

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.

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: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The Change in Positive and Negative Syndrome Scale(PANSS)Total Score

Secondary outcome:

Positive and Negative Syndrome Scale (PANSS) Positive Score

Positive and Negative Syndrome Scale (PANSS) Negative Score

Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score

Clinical Global Impression (CGI) Score

Montgomery-Asberg Depression Rating Scale (MADRS) Total Score

Global Assessment of Functioning (GAF) Score

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. 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

Research site, Incheon, Korea, Republic of

Research site, Pusan, Korea, Republic of

Research site, Seoul, 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: November 2008
Last updated: October 19, 2011

Page last updated: August 23, 2015

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