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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Quetiapine Fumarate XR | Experimental | Seroquel XR 400-800mg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quetiapine Fumarate XR | Drug | oral, once daily, flexible dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | From baseline to Day 57 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | From baseline to Day 57 |
| Positive and Negative Syndrome Scale (PANSS) Negative Score |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| YounHoon Kim | Inje University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research site | Ansan | Gyeonggi-do | South Korea | |||
| Research site |
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From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea
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| ID | Title | Description |
|---|---|---|
| FG000 | Quetiapine XR | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Quetiapine XR | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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 | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
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Safety population who were taking at least one dose of study treatment were used for the safety analyses (94) participants
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Quetiapine XR | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Insomnia | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | aztrial_results_posting@astrazeneca.com |
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| ID | Term |
|---|---|
| D012559 | Schizophrenia |
| ID | Term |
|---|---|
| D019967 | Schizophrenia Spectrum and Other Psychotic Disorders |
| D001523 | Mental Disorders |
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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) |
| From baseline to Day 57 |
| 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) | From baseline to Day 57 |
| 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 | From baseline to Day 57 |
| 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. | From baseline to Day 57 |
| 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. | From baseline to Day 57 |
| Gwangju |
| Gyeonggi-do |
| South Korea |
| Research site | Bugok | Gyeongsangnam-do | South Korea |
| Research site | Masan | Gyeongsangnam-do | South Korea |
| Research site | Incheon | South Korea |
| Research site | Pusan | South Korea |
| Research site | Seoul | South Korea |
| Protocol Violation |
|
| Withdrawal by Subject |
|
| Lost to Follow-up |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| BMI | Mean | Standard Deviation | kg/m2 |
|
| Height | Mean | Standard Deviation | cm |
|
| Weight | Mean | Standard Deviation | kg |
|
|
|
| Secondary | 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) | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| Secondary | 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) | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| Secondary | 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) | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| Secondary | 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 | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| Secondary | 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. | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| Secondary | 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. | The MITT set was used for primary analyses (89) participants | Posted | Mean | Standard Deviation | score on a scale | From baseline to Day 57 |
|
|
|
| 0 |
| 94 |
| 94 |
| 94 |
| Anxiety | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Agitation | Psychiatric disorders | MedDRA 10.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Dyspepsia | Gastrointestinal disorders | MedDRA 10.0 | Systematic Assessment |
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| Toothache | General disorders | MedDRA 10.0 | Systematic Assessment |
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| Sedation | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
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| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
|
| Dysuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
|
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