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Trial record 37 of 450 for:    QUETIAPINE

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

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Schizophrenia
Intervention Drug: Quetiapine Fumarate XR
Enrollment 96
Recruitment Details From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea
Pre-assignment Details  
Arm/Group Title Quetiapine XR
Hide Arm/Group Description 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
Period Title: Overall Study
Started 96
Enrolled 96
Screen Failed 2
Assigned 94
MITT 89
Treatment Complete 67
Withdrawal Treatment 27
Completed 67
Not Completed 29
Reason Not Completed
Screening Failed             2
Adverse Event             4
Lack of Efficacy             11
Protocol Violation             5
Withdrawal by Subject             6
Lost to Follow-up             1
Arm/Group Title Quetiapine XR
Hide Arm/Group Description 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
Overall Number of Baseline Participants 89
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 89 participants
Female 35.8  (13)
Male 42.4  (9.8)
Total 39.7  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 89 participants
Female
37
  41.6%
Male
52
  58.4%
BMI  
Mean (Standard Deviation)
Unit of measure:  Kg/m2
Number Analyzed 89 participants
Female 23.7  (5.4)
Male 23.4  (3.5)
Total 23.5  (4.4)
Height  
Mean (Standard Deviation)
Unit of measure:  Cm
Number Analyzed 89 participants
Female 158  (5.9)
Male 168.7  (6.6)
Total 164.2  (8.2)
Weight  
Mean (Standard Deviation)
Unit of measure:  Kg
Number Analyzed 89 participants
Female 59.1  (13)
Male 66.6  (11.4)
Total 63.5  (12.6)
1.Primary Outcome
Title The Change in Positive and Negative Syndrome Scale(PANSS)Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-26.8  (4.2)
2.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Positive Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-7.4  (1.2)
3.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) Negative Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-6.2  (1.3)
4.Secondary Outcome
Title Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-13.2  (2.3)
5.Secondary Outcome
Title Clinical Global Impression (CGI) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-1.46  (0.25)
6.Secondary Outcome
Title Montgomery-Asberg Depression Rating Scale (MADRS) Total Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 89
Mean (Standard Deviation)
Unit of Measure: score on a scale
-9.44  (2)
7.Secondary Outcome
Title Global Assessment of Functioning (GAF) Score
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
The MITT set was used for primary analyses (89) participants
Arm/Group Title Quetiapine XR
Hide Arm/Group Description:
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
Overall Number of Participants Analyzed 81
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.9  (2.9)
Time Frame [Not Specified]
Adverse Event Reporting Description Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
 
Arm/Group Title Quetiapine XR
Hide Arm/Group Description 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
All-Cause Mortality
Quetiapine XR
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine XR
Affected / at Risk (%)
Total   0/94 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine XR
Affected / at Risk (%)
Total   94/94 (100.00%) 
Gastrointestinal disorders   
Constipation  1  24/94 (25.53%) 
Dyspepsia  1  9/94 (9.57%) 
General disorders   
Toothache  1  5/94 (5.32%) 
Nervous system disorders   
Sedation  1  12/94 (12.77%) 
Headache  1  8/94 (8.51%) 
Dizziness  1  5/94 (5.32%) 
Psychiatric disorders   
Insomnia  1  22/94 (23.40%) 
Anxiety  1  11/94 (11.70%) 
Agitation  1  5/94 (5.32%) 
Renal and urinary disorders   
Dysuria  1  5/94 (5.32%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 10.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Gerard Lynch
Organization: AstraZeneca
EMail: aztrial_results_posting@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00779506     History of Changes
Other Study ID Numbers: D1443L00062
First Submitted: October 22, 2008
First Posted: October 24, 2008
Results First Submitted: May 20, 2010
Results First Posted: November 23, 2011
Last Update Posted: November 23, 2011