Comparison of Quetiapine Extended-Release (Seroquel XR? ) andRisperidone in the treatment of depressive symptoms, in schizophrenic or schizoaffective patients: A randomized, open label, flexible-dose, parallel group, non inferiority, 12-week study - ND

• Conditions: Patient with schizophrenia or schizoaffective disorder with depressive symptoms; MedDRA version: 9.1Level: HLTClassification code 10039620Term: Schizoaffective and schizophreniform disorders

• Registration Number: EUCTR2007-004246-32-IT
• Lead Sponsor: ASTRAZENECA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12-10
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Provision of written informed consent.
2. Male or female patients aged > or equal 18 - < or equal 65 years.
3. Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR.
4. Baseline depressive symptoms, assessed by means of HAM-D (21-item) score > 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

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 < or equal to 1.5 x 109 per liter.
16. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or
a danger to self or others.
17. Use of any of the following cytochrome P450 3A4 inhibitors in the 14 days preceding enrolment including but not limited to: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nelfinavir,
ritonavir, fluvoxamine and saquinavir.
18. Use of any of the following cytochrome P450 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates,
rifampin, St. John?s Wort, and glucocorticoids.
19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria:
− Unstable DM defined as enrollment glycosylated hemoglobin (HbA1c) >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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified