Schizophrenia
Conditions
Keywords
Quetiapine efficacy in schizophrenia
Brief summary
The purpose of this study is to evaluate the efficacy of Seroquel XR in schizophrenia patients with acute worsening symptoms. Consequently, to assess whether the study drug is safe and acceptable on the daily dose basis, orally given, up to 600 mg once a day for 42 days.
Interventions
600mg Extended release tablet, oral, once daily
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
Yes
Inclusion criteria
* Patient meets the DSM-IV criteria for schizophrenia * Patient has a PANSS total score ≥ 70 at baseline * Patient has a CGI-S score of ≥ 4(moderately ill) at baseline * Patient is healthy on the basis of physical examination and vital signs at baseline
Exclusion criteria
* Positive urine drug screen for Opiates, amphetamine, barbiturate, cocaine, cannabis, or ecstasy abuse * Has history of neuroleptic malignant syndrome, seropositive for anti-HIV, hepatitis B or C virus antigen * Patient with unstable or inadequately treated Diabetes Mellitus * Use of potent cytochrome P450 inhibitors or inducer within 14 days before baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Positive and Negative Syndrome Scale (PANSS) Total Score | From Day 1 (baseline) to Day 42 | Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Clinical Global Impression - Severity of Illness (CGI-S) Score | From Day 1 (Baseline) to Day 42 | Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline \> 1 score. |
| Clinical Global Impression - Severity of Illness (CGI-S) Score | Day 14 | Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline \> 1 score. |
Countries
Thailand
Participant flow
Recruitment details
Patients provide informed consent and are screened for eligibility (at Visit 1) up to 7 days before baseline assessment on Day 1.
Pre-assignment details
On Day 1, baseline assessments will be performed, and patients will be assigned to Seroquel XR at 300 mg. On Day 2 all patients are assigned to reach target dose of Seroquel XR at 600 mg. Administration of study medication continue with Seroquel XR 600 mg daily until Day 42. Each visit will have ± 3 days window period.
Participants by arm
| Arm | Count |
|---|---|
| Seroquel XR Seroquel XR 300mg on day 1, 600mg from day 2 onwards. The treatment period will take 6 weeks or 42 days. | 28 |
| Total | 28 |
Baseline characteristics
| Characteristic | Seroquel XR |
|---|---|
| Age Continuous | 43 Years STANDARD_DEVIATION 39.5 |
| Sex: Female, Male Female | 8 Participants |
| Sex: Female, Male Male | 20 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 14 / 28 |
| serious Total, serious adverse events | 1 / 28 |
Outcome results
Primary
Change in Positive and Negative Syndrome Scale (PANSS) Total Score
Change in Positive and Negative Syndrome Scale Total Score from Day 1 (baseline) to Day 42 (final visit) or withdrawal. Minimum value of total PANSS is 30 , Maximum is 210. Minimum value considered better is score decreased from baseline at least 30%.
Time frame: From Day 1 (baseline) to Day 42
Population: The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seroquel XR | Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Day 1 (Baseline) (n= 28) | 85.3 Scores on a scale | Standard Deviation 28.8 |
| Seroquel XR | Change in Positive and Negative Syndrome Scale (PANSS) Total Score | Day 42 (n= 17) | 48.5 Scores on a scale | Standard Deviation 28.6 |
Secondary
Change in Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline \> 1 score.
Time frame: From Day 1 (Baseline) to Day 42
Population: The number of patient at Day 42 (n= 17) is different than at Baseline (n= 28), because some of them withdraw/terminate during the study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Seroquel XR | Change in Clinical Global Impression - Severity of Illness (CGI-S) Score | Day 1 (Baseline) (n= 28) | 4.6 Scores on a scale | Standard Deviation 0.7 |
| Seroquel XR | Change in Clinical Global Impression - Severity of Illness (CGI-S) Score | Day 42 (n= 17) | 2.7 Scores on a scale | Standard Deviation 1.1 |
Secondary
Clinical Global Impression - Severity of Illness (CGI-S) Score
Clinical Global Impression - Severity of Illness. Maximum possible value is 7 (worst outcome), the minimum is 1 (best outcome). Values are considered better outcome: decrease from baseline \> 1 score.
Time frame: Day 14
Population: The number of patient is different, because some of them withdraw/terminate during the study.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Seroquel XR | Clinical Global Impression - Severity of Illness (CGI-S) Score | 3.2 Scores on a scale | Standard Deviation 1.1 |