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

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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

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.


Condition or disease Intervention/treatment Phase
Schizophrenia Drug: Quetiapine Fumarate XR Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : November 2008
Primary Completion Date : July 2009
Study Completion Date : July 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Quetiapine Fumarate XR
Seroquel XR 400-800mg
Drug: Quetiapine Fumarate XR
oral, once daily, flexible dose
Other Name: Seroquel XR



Primary Outcome Measures :
  1. 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



Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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)

  4. 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

  5. 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.

  6. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00779506


Locations
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
Research site
Incheon, Korea, Republic of
Research site
Pusan, Korea, Republic of
Research site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: YounHoon Kim Inje University

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00779506     History of Changes
Other Study ID Numbers: D1443L00062
First Posted: October 24, 2008    Key Record Dates
Results First Posted: November 23, 2011
Last Update Posted: November 23, 2011
Last Verified: May 2010

Keywords provided by AstraZeneca:
Acute schizophrenia
PANSS

Additional relevant MeSH terms:
Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Quetiapine Fumarate
Antipsychotic Agents
Tranquilizing Agents
Central Nervous System Depressants
Physiological Effects of Drugs
Psychotropic Drugs