Back to resultsStudy of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR) (QUENCH)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 4
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Quetiapine Fumarate XR
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Acute schizophrenia, PANSS
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
Sites / Locations
- Research site
- Research site
- Research site
- Research site
- Research site
- Research site
- Research site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Quetiapine Fumarate XR
Arm Description
Seroquel XR 400-800mg
Outcomes
Primary Outcome Measures
The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
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
Positive and Negative Syndrome Scale (PANSS) Positive Score
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
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
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
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
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
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00779506
Brief Title
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Acronym
QUENCH
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
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Completed
Study Start Date
November 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
July 2009 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Acute schizophrenia, PANSS
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
96 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Quetiapine Fumarate XR
Arm Type
Experimental
Arm Description
Seroquel XR 400-800mg
Intervention Type
Drug
Intervention Name(s)
Quetiapine Fumarate XR
Other Intervention Name(s)
Seroquel XR
Intervention Description
oral, once daily, flexible dose
Primary Outcome Measure Information:
Title
The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
Description
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
Time Frame
From baseline to Day 57
Secondary Outcome Measure Information:
Title
Positive and Negative Syndrome Scale (PANSS) Positive Score
Description
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)
Time Frame
From baseline to Day 57
Title
Positive and Negative Syndrome Scale (PANSS) Negative Score
Description
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)
Time Frame
From baseline to Day 57
Title
Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
Description
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)
Time Frame
From baseline to Day 57
Title
Clinical Global Impression (CGI) Score
Description
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
Time Frame
From baseline to Day 57
Title
Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Description
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.
Time Frame
From baseline to Day 57
Title
Global Assessment of Functioning (GAF) Score
Description
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.
Time Frame
From baseline to Day 57
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
YounHoon Kim
Organizational Affiliation
Inje University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research site
City
Ansan
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research site
City
Gwangju
State/Province
Gyeonggi-do
Country
Korea, Republic of
Facility Name
Research site
City
Bugok
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Research site
City
Masan
State/Province
Gyeongsangnam-do
Country
Korea, Republic of
Facility Name
Research site
City
Incheon
Country
Korea, Republic of
Facility Name
Research site
City
Pusan
Country
Korea, Republic of
Facility Name
Research site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
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