Schizophrenia MedDRA version: 9.1 Level: PT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: Seroquel Prolong 200 mg
Product Name: Seroquel Prolong
Pharmaceutical Form: Prolonged-release tablet
INN or Proposed INN: QUETIAPINE
CAS Number: 111974697
Current Sponsor code: ZD5077
Conc
Sponsors
AstraZeneca Oy
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of informed, written consent 2. Male or female, aged 18 - 65 3. In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia, schizoaffective disorder or schizophreniformic psychosis (according to DSM-IV diagnostic criteria). 4. Female patients of childbearing potential must be using a reliable method of contraception and have a negative urine human chorionic gonadotropin (HCG) test at enrolment. 5. Be able to understand and comply with the requirements of the study. 6. PANSS = 65 7. CGI = 4 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. Pregnancy or lactation 2. Any DSM-IV Axis I disorder not defined in the inclusion criteria 3. In-patients/hospitalized > 7 days before enrolment 4. Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others 5. Known intolerance or lack of response to quetiapine fumarate or risperidone, as judged by the investigator 6. 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 7. Use of any of the following cytochrome P450 3A4 inducers in the 14 days preceding enrolment including but not limited to: phenytoin, carbamazepine, barbiturates, rifampin, St. John’s Wort, and glucocorticoids 8. Administration of a depot antipsychotic injection within one dosing interval (for the depot) before randomisation 9. Treatment with clozapine must have stopped at least 28 days prior to randomisation 10. Patients taking antidepressant drugs (SSRIs or SRNIs) or mood stabilizers (lithium or divalproax) must have been on a stable dose at least two weeks prior to enrolment 11. Substance or alcohol dependence at enrolment (except dependence in full remission, and except for caffeine or nicotine dependence), as defined by DSM-IV-criteria 12. Opiates, amphetamine, barbiturate, cocaine, cannabis, or hallucinogen abuse by DSM-IV criteria within 4 weeks prior to enrolment 13. Medical conditions that would affect absorption, distribution, metabolism, or excretion of study treatment 14. Unstable or inadequately treated medical illness (eg,. congestive heart failure, angina pectoris, hypertension) as judged by the investigator 15. Involvement in the planning and conduct of the study 16. Previous enrolment or randomisation of treatment in the present study 17. Participation in another drug trial within 4 weeks prior enrolment into this study or longer in accordance with local requirement 18. An absolute neutrophil count (ANC) of = 1,0 x 109 /L 19. A patient with Diabetes Mellitus (DM) fulfilling one of the following criteria: - Unstable DM defined as enrolment glycosylated hemoglobin (HbA1c) >8.5%. - Admitted to hospital for treatment of DM or DM related illness in past 12 weeks. - 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 randomisation. 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 if the treating physician believes that the patient is stable and can participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate change of agitation in acute schizophrenic patients.;Secondary Objective: Secondary objectives are: - to test different scales in normal clinical practice in acute setting - to evaluate safety and tolerability - to evaluate treatment adherence;Primary end point(s): The primary variable is change from baseline in PANSS-EC score. | — |
Countries
Finland
Outcome results
None listed