| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Patient with schizophrenia or schizoaffective disorder with depressive symptoms |
|
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 9.1 |
| E.1.2 | Level | HLT |
| E.1.2 | Classification code | 10039620 |
| E.1.2 | Term | Schizoaffective and schizophreniform disorders |
|
| E.1.3 | Condition being studied is a rare disease | No |
| E.2 Objective of the trial |
| E.2.1 | Main objective of the trial |
| 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 |
|
| E.2.2 | Secondary objectives of the trial |
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. |
|
| E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
| E.3 | Principal 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. |
|
| E.4 | Principal 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 |
|
| E.5 End points |
| E.5.1 | 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 |
|
| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | No |
| E.6.2 | Prophylaxis | No |
| E.6.3 | Therapy | No |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | No |
| E.6.7 | Pharmacodynamic | No |
| E.6.8 | Bioequivalence | No |
| E.6.9 | Dose response | No |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | No |
| E.6.12 | Pharmacoeconomic | No |
| E.6.13 | Others | Information not present in EudraCT |
| E.7 | Trial type and phase |
| E.7.1 | Human pharmacology (Phase I) | No |
| E.7.1.1 | First administration to humans | No |
| E.7.1.2 | Bioequivalence study | No |
| E.7.1.3 | Other | No |
| E.7.1.3.1 | Other trial type description | |
| E.7.2 | Therapeutic exploratory (Phase II) | No |
| E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| E.8 Design of the trial |
| E.8.1 | Controlled | Yes |
| E.8.1.1 | Randomised | Yes |
| E.8.1.2 | Open | Yes |
| E.8.1.3 | Single blind | No |
| E.8.1.4 | Double blind | No |
| E.8.1.5 | Parallel group | Yes |
| E.8.1.6 | Cross over | No |
| E.8.1.7 | Other | No |
| E.8.2 | Comparator of controlled trial |
| E.8.2.1 | Other medicinal product(s) | Yes |
| E.8.2.2 | Placebo | No |
| E.8.2.3 | Other | No |
| E.8.3 |
The trial involves single site in the Member State concerned
| No |
| E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
| E.8.5 | The trial involves multiple Member States | No |
| E.8.6 Trial involving sites outside the EEA |
| E.8.6.1 | Trial being conducted both within and outside the EEA | No |
| E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
| E.8.7 | Trial has a data monitoring committee | Information not present in EudraCT |
| E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
| |
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 1 |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial years | 1 |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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