Schizophrenia
Conditions
Keywords
Acute schizophrenia, PANSS
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.
Interventions
oral, once daily, flexible dose
Sponsors
AstraZeneca
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Change in Positive and Negative Syndrome Scale(PANSS)Total Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Positive and Negative Syndrome Scale (PANSS) Negative Score | 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 | 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) |
| Positive and Negative Syndrome Scale (PANSS) Positive Score | 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) |
| Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | 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 | 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. |
| Clinical Global Impression (CGI) Score | 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 |
Countries
South Korea
Participant flow
Recruitment details
From 4 Nov 2008 to 9 July 2009, 96 subjects were enrolled from 9 centers in Korea
Participants by arm
| Arm | Count |
|---|---|
| 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 | 89 |
| Total | 89 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 4 |
| Overall Study | Lack of Efficacy | 11 |
| Overall Study | Lost to Follow-up | 1 |
| Overall Study | Protocol Violation | 5 |
| Overall Study | Screening Failed | 2 |
| Overall Study | Withdrawal by Subject | 6 |
Baseline characteristics
| Characteristic | Quetiapine XR |
|---|---|
| Age Continuous Female | 35.8 Years STANDARD_DEVIATION 13 |
| Age Continuous Male | 42.4 Years STANDARD_DEVIATION 9.8 |
| Age Continuous Total | 39.7 Years STANDARD_DEVIATION 11.6 |
| BMI Female | 23.7 kg/m2 STANDARD_DEVIATION 5.4 |
| BMI Male | 23.4 kg/m2 STANDARD_DEVIATION 3.5 |
| BMI Total | 23.5 kg/m2 STANDARD_DEVIATION 4.4 |
| Height Female | 158 cm STANDARD_DEVIATION 5.9 |
| Height Male | 168.7 cm STANDARD_DEVIATION 6.6 |
| Height Total | 164.2 cm STANDARD_DEVIATION 8.2 |
| Sex: Female, Male Female | 37 Participants |
| Sex: Female, Male Male | 52 Participants |
| Weight Female | 59.1 kg STANDARD_DEVIATION 13 |
| Weight Male | 66.6 kg STANDARD_DEVIATION 11.4 |
| Weight Total | 63.5 kg STANDARD_DEVIATION 12.6 |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 94 / 94 |
| serious Total, serious adverse events | 0 / 94 |
Outcome results
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
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | The Change in Positive and Negative Syndrome Scale(PANSS)Total Score | -26.8 score on a scale | Standard Deviation 4.2 |
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
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Clinical Global Impression (CGI) Score | -1.46 score on a scale | Standard Deviation 0.25 |
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.
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Global Assessment of Functioning (GAF) Score | 17.9 score on a scale | Standard Deviation 2.9 |
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.
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Montgomery-Asberg Depression Rating Scale (MADRS) Total Score | -9.44 score on a scale | Standard Deviation 2 |
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)
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Positive and Negative Syndrome Scale (PANSS) General Psychopathology Score | -13.2 score on a scale | Standard Deviation 2.3 |
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)
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Positive and Negative Syndrome Scale (PANSS) Negative Score | -6.2 score on a scale | Standard Deviation 1.3 |
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)
Time frame: From baseline to Day 57
Population: The MITT set was used for primary analyses (89) participants
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Quetiapine XR | Positive and Negative Syndrome Scale (PANSS) Positive Score | -7.4 score on a scale | Standard Deviation 1.2 |