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Trial record 61 of 450 for:    QUETIAPINE

Efficacy and Safety of SEROQUEL Extended Release (XR) in Acute Schizophrenia

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ClinicalTrials.gov Identifier: NCT00954122
Recruitment Status : Completed
First Posted : August 7, 2009
Results First Posted : January 8, 2013
Last Update Posted : January 8, 2013
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 XR (Seroquel XR)
Enrollment 35
Recruitment Details 18 Years to 65 Years Male & Female Acte schizophrenia (DSM-IV) Positive and Negative Syndrome Scale (PANSS) score at least 75, Clinical Global Impression (CGI)
Pre-assignment Details 40 patients enrolled, 35 patients randomised and 28 patients completed the study
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
Period Title: Overall Study
Started 35
Completed 28
Not Completed 7
Reason Not Completed
Withdrawal by Subject             5
Adverse Event             1
Safety Reason             1
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
Overall Number of Baseline Participants 35
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
<=18 years
0
   0.0%
Between 18 and 65 years
35
 100.0%
>=65 years
0
   0.0%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 35 participants
38.3  (11)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants
Female
11
  31.4%
Male
24
  68.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Malaysia Number Analyzed 35 participants
35
1.Primary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score
Hide Description PANSS- Excited Component (EC) subscale score will be calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14). This is rated on a 7-point Likert scale from ‘absent’ to ‘extremely severe’ (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation). Lower value gives the better outcome.
Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS-EC score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-7.5  (4)
2.Secondary Outcome
Title Change From Baseline to Final Visit at Day 21 in PANSS Positive, General Psychopathological Scores.
Hide Description

Positive scale includes 7 Items (Delusions, Conceptual disorganization, Hallucinations, Hyperactivity, Grandiosity, Suspiciousness/persecution, Hostility)and is calculated by adding the positive subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale:16 items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. The biggest reduction of score from baseline- a better efficacy.

Measure includes PANSS-Positive (range 8-30), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).

Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Negative score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-9.3  (5.5)
3.Secondary Outcome
Title Change From Baseline to Final Visit at Day 21 in PANSS Negative, General Psychopathological Scores
Hide Description Negative scale includes 7 items (Blunted affect, Emotional withdrawal, Poor rapport, Passive/apathetic social withdrawal, Difficulty in abstract thinking, Lack of spontaneity and flow of conversation, Stereotyped thinking)and is calculated by adding the negative subscale item scores. Minimum score is 7, maximum score is 49. General Psychopathology scale includes 16 Items (Somatic concern, Anxiety, Guilt feelings, Tension, Mannerisms and posturing, Depression, Motor retardation, Uncooperativeness, Unusual thought content, Disorientation, Poor attention, Lack of judgment and insight, Disturbance of volition, Poor impulse control, Preoccupation, Active social avoidance). Minimum score is 16, maximum score is 112. The higher score- the worse outcome. Measure includes PANSS-Negative (range 8-37), PANSS-General Psychopathological (PANSS-G)(range 17-70), total PANSS score (range 37-143), PANSS aggression, hostility and depression cluster scores (range 4-19).
Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Positive score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-5.7  (4.9)
4.Secondary Outcome
Title Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score
Hide Description Positive and Negative Syndrome Scale (PANSS) total score is a medical scale used for measuring symptom severity of patients with schizophrenia. It is calculated by adding together PANSS-Positive (minimum score = 7, maximum score = 49, PANSS-Negative (minimum score = 7, maximum score = 49), PANSS-General Psychopathological (PANSS-G) subscale scores (minimum score = 16, maximum score = 112), supplementary subscale item scores. The minimum is 30, maximum is 210. Total PANSS score classification: Mildly ill 58- 74, Moderately ill 75-94, Markly ill 95- 115, Severely ill >116.
Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on PANSS Total score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-33.2  (21.3)
5.Secondary Outcome
Title Change From Baseline in Clinical Global Impression-Severity Scale (CGI-S)
Hide Description

Clinical Global Impression, Severity (CGI-S) is a single-item (7-point) scale that evaluates the overall severity of the subject’s mental illness. A reduction in score indicates an improvement in the subject’s condition. The CGI-S assessment should be based upon the subject’s symptoms during the previous week.

Change from baseline in CGI-S score is calculated by subtracting the CGI-S score at baseline from the CGI-S score at the relevant time point.

Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-S score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: scores on a scale
-1.2  (0.9)
6.Secondary Outcome
Title Change From Baseline in Absolute Clinical Global Impression-Improvement (CGI-I) Scale
Hide Description

Clinical Global Impression, Improvement (CGI-I) is a single-item (7-point) scale that evaluates the overall improvement in the subject’s mental. A reduction in score indicates an improvement in the subject’s condition. This assessment is based on the improvement since initiation of the study treatment.

Change in CGI-I score is analyzed by comparing CSI-score at the relevant time point to the baseline CGI-I score.

Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS (Positive and Negative Syndrome Scale) assessments. No imputation on CGI-I score.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
Baseline 3.9  (0.4)
Day 21 2.4  (1.2)
7.Secondary Outcome
Title Change of the Positive and Negative Syndrome Scale Excited Component (PANSS-EC) Score Compared From Baseline to Day 21.
Hide Description

Excited Component was used to evaluate the control of agitation and aggression in patients with schizophrenia.

Difference in mean score at baseline and day 21 is used to assess the improvement. It is shown by reduction in mean score and confirmed by p value lower than 0,05.

Positive and Negative Syndrome Scale Excited Component (PANSS-EC) is a subscale score which is calculated by adding together the following item scores: excitement (positive subscale item 4); hostility (positive subscale item 7); tension (general subscale item 4); uncooperativeness (general subscale item 8); poor impulse control (general subscale item 14).

This is rated on a 7-point Likert scale from 'absent' to 'extremely severe' (score range 5 to 35 points; mean scores = 20 points clinically corresponds to severe agitation).

Time Frame Baseline and Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
ITT population, which comprise of patients who have baseline and at least ONE (1) set of post-baseline PANSS assessments. No imputation on Outcome Measurement.
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description:
This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator's discretion) on day 3 and onwards
Overall Number of Participants Analyzed 35
Mean (Standard Deviation)
Unit of Measure: Scores on a scale
-33.2  (21.3)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Quetiapine Fumarate XR
Hide Arm/Group Description This is a one arm Study. Patients were on quetiapine XR 300 mg on day 1, 600 mg on day 2, and 400-800 mg (at investigator’s discretion) on day 3 and onwards
All-Cause Mortality
Quetiapine Fumarate XR
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Quetiapine Fumarate XR
Affected / at Risk (%)
Total   1/35 (2.86%) 
Psychiatric disorders   
Hospitalization  1/35 (2.86%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Quetiapine Fumarate XR
Affected / at Risk (%)
Total   0/35 (0.00%) 
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
Phone: 4415 09645895
EMail: clinicaltrialtransparency@astrazeneca.com
Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00954122     History of Changes
Other Study ID Numbers: D1443L00074
First Submitted: August 6, 2009
First Posted: August 7, 2009
Results First Submitted: May 18, 2011
Results First Posted: January 8, 2013
Last Update Posted: January 8, 2013