Patient with schizophrenia or schizoaffective disorder with depressive symptoms MedDRA version: 9.1 Level: HLT Classification code 10039620 Term: Schizoaffective and schizophreniform disorders
Conditions
Interventions
Trade Name: Seroquel XR Extended-release Tablets
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: Quetiapine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentrati
Sponsors
ASTRAZENECA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent. 2. Male or female patients aged > or equal 18 - or equal 20, and HAM-D item 1 score > or equal 2. 5. Able to understand and comply with the requirements of the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder. 2. Pregnancy or breast-feeding. Women of childbearing potential must use a reliable contraceptive method. 3. Patients with previous intolerance or unresponsiveness to quetiapine or risperidone. 4. Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period. 5. Use of clozapine within 28 days prior to enrolment or clozapine non responders. 6. Known previous sensitivity to quetiapine IR or risperidone. 7. Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug. 8. Serious unstable medical conditions (patients with, renal haemopoietic, endocrinology impairments). 9. Patients with unstable or un-adequately treated medical illness e.g. angina pectoris, hypertension, congestive heart failure, as judged by the investigators. 10. Liver function tests AST or ALT three times the upper normal limit. 11. Pre-existing organic mental disorder. 12. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site). 13. Previous enrolment or randomisation of treatments in the present study. 14. Participation in a clinical study during the last 30 days. 15. An absolute neutrophil count (ANC) of 8.5%. − Admitted to hospital for treatment of DM or DM related illness in past 12 week. − Not under physician care for DM. − Physician responsible for patient?s DM care has not indicated that patient?s DM is controlled. − Physician responsible for patient?s DM care has not approved patient?s participation in the study. − Has not been on the same dose of oral hypoglycaemic drug(s) and/or diet for the 4 weeks prior to randomization. For thiazolidinediones (glitazones) this period should not be less than 8 weeks. − Taking insulin whose daily dose on one occasion in the past 4 weeks has been more than 10% above or below their mean dose in the preceding 4 weeks. Note: if a diabetic patient meets one of these criteria, the patient is to be excluded even
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of Seroquel XR versus risperidone on depressive symptoms assessed with Calgary Depression Scale for Schizophrenia (CDSS), in schizophrenic or schizoaffective patients;Secondary Objective: 1. To evaluate efficacy of Seroquel XR vs. risperidone on negative and positive symptoms, in Schizophrenic or Schizoaffective patients, assessed with Positive and negative Syndrome Scale (PANSS). 2. To evaluate efficacy of Seroquel XR vs. risperidone on attitude towards treatment in Schizophrenic or Schizoaffective patients, assessed with Drug Attitude Inventory (DAI - 10). 3. To evaluate the global efficacy of Seroquel XR vs. risperidone in Schizophrenic or Schizoaffective patients, assessed with Clinical Global Impression (CGI). 4. To assess the safety and tolerability of Seroquel XR vs. risperidone in Schizophrenic or Schizoaffective patients. 5. To assess the Prolactin Levels (PRL) of Seroquel XR vs. risperidone in Schizophrenic or Schizoaffective patients. 6. To assess the concomitant use of antidepressant drugs.;Primary end point(s): The primary endpoint is to conclude that the true mean CDSS score reduction for Seroquel XR is at most 2.7 point less than the true mean reduction of the risperidone. Calculating a one-sided non-inferiority testing procedure at a significant level of 0.05 with a power of 0.80 and estimating a standard deviation of 7, 107 patients for each group will be enough to detect it. Assuming that 26% of the participants could be lost, 290 patients will be enrolled in order to obtain 214 valuable subjects | — |
Countries
Italy
Outcome results
None listed