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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00779506
Recruitment Status : Completed
First Posted : October 24, 2008
Results First Posted : November 23, 2011
Last Update Posted : November 23, 2011
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Tracking Information
First Submitted Date  ICMJE October 22, 2008
First Posted Date  ICMJE October 24, 2008
Results First Submitted Date  ICMJE May 20, 2010
Results First Posted Date  ICMJE November 23, 2011
Last Update Posted Date November 23, 2011
Study Start Date  ICMJE November 2008
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
The Change in Positive and Negative Syndrome Scale(PANSS)Total Score [ Time Frame: 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
Original Primary Outcome Measures  ICMJE
 (submitted: October 23, 2008)
Change in PANSS total score [ Time Frame: From baseline to Day 57 ]
Change History Complete list of historical versions of study NCT00779506 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 19, 2011)
  • Positive and Negative Syndrome Scale (PANSS) Positive Score [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2008)
  • Change in PANSS positive scale score [ Time Frame: From baseline to Day 57 ]
  • Change in PANSS negative scale score [ Time Frame: From baseline to Day 57 ]
  • Change in PANSS general psychopathology score [ Time Frame: From baseline to Day 57 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of the Efficacy and Safety of Quetiapine Fumarate Extended Release (Seroquel XR)
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Schizophrenia
Intervention  ICMJE Drug: Quetiapine Fumarate XR
oral, once daily, flexible dose
Other Name: Seroquel XR
Study Arms  ICMJE Experimental: Quetiapine Fumarate XR
Seroquel XR 400-800mg
Intervention: Drug: Quetiapine Fumarate XR
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2011)
96
Original Estimated Enrollment  ICMJE
 (submitted: October 23, 2008)
100
Actual Study Completion Date  ICMJE July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00779506
Other Study ID Numbers  ICMJE D1443L00062
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party AstraZeneca
Study Sponsor  ICMJE AstraZeneca
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: YounHoon Kim Inje University
PRS Account AstraZeneca
Verification Date May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP