Clinical trial NCT00779506: Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Schizophrenia
Keywords: Acute schizophrenia
PANSS
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-10-24
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
timeFrame: From baseline to Day 57
Secondary outcomes:
measure: Positive and Negative Syndrome Scale (PANSS) Positive Score
timeFrame: From baseline to Day 57
measure: Positive and Negative Syndrome Scale (PANSS) Negative Score
timeFrame: From baseline to Day 57
measure: Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
timeFrame: From baseline to Day 57
measure: Clinical Global Impression (CGI) Score
timeFrame: From baseline to Day 57
measure: Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
timeFrame: From baseline to Day 57
measure: Global Assessment of Functioning (GAF) Score
timeFrame: From baseline to Day 57
Other outcomes:
Locations:
city: Ansan
country: Korea, Republic of
facility: Research site
state: Gyeonggi-do
city: Gwangju
country: Korea, Republic of
facility: Research site
state: Gyeonggi-do
city: Bugok
country: Korea, Republic of
facility: Research site
state: Gyeongsangnam-do
city: Masan
country: Korea, Republic of
facility: Research site
state: Gyeongsangnam-do
city: Incheon
country: Korea, Republic of
facility: Research site
city: Pusan
country: Korea, Republic of
facility: Research site
city: Seoul
country: Korea, Republic of
facility: Research site
Study officials:
affiliation: Inje University
name: YounHoon Kim
role: PRINCIPAL_INVESTIGATOR
References: