Patients requiring treatment, as judged by the Investigator, for an acute episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV criteria).
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel
Pharmaceutical Form: Film-coated tablet
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Provision of written informed consent before initiation of any study-related procedure. 2. Male or female, aged 18-65 years. 3. Requirement of hospitalization and in need for antipsychotic treatment for an acute psychotic episode of schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania (according to DSM-IV diagnostic criteria). 4. Patients who are able to swallow tablets from Day 1 of the study period and who are expected not to be in need of other antipsychotic medication during the study, as judged by the Investigator. 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. In-patients who are anticipated to be discharged before evaluation of the primary outcome variable at Day 5. 2. Patients with known relevant clinical disease (renal or hepatic impairment; cardiovascular- or cerebrovascular disease; congestive heart failure; diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator. 3. History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator. 4. Patients with known neutropenia. Patients with an absolute neutrophil count (ANC) of less or equal to 1.5 x 10 9/L will be excluded from the study. Patients with fever at enrolment must not be included in the study if no ANC result is available. 5. Treatment with clozapine within 28 Days prior to enrolment in this study. 6. Administration of Cytochrome P450 inducers or Cytochrome P450 inhibitors in the 14 Days preceding enrolment into the study, or concomitant use during the study, including, but not limited to, the following: - Cytochrome P450 inducers: phenytoin, carbamazepine, barbiturates, rifampin, St John’s Wort and glucocorticoids - Cytochrome P450 inhibitors: ketoconazole, itraconazole, fluconazole, erythromycin, clarithromycin, troleandomycin, indinavir, nalfinavir, ritonavir, fluvoxamine, saquinavir and grape fruit juice 7. Known intolerance or lack of response to quetiapine, as judged by the Investigator. 8. Pregnancy or lactation. Females of childbearing potential must use a reliable method of contraception i.e. hormonal contraceptives, double-barrier methods, intra-uterine device or tubal ligation, unless their sexual partner is sterile (vasectomy). 9. Patients who pose an imminent risk of suicide, or danger to self or others, as judged by the Investigator. 10. Acute intoxication due to alcohol or drug dependence at enrolment. 11. Involvement in the planning and conduct of this study (applies to both AstraZeneca staff or staff at the study site) 12. Previous enrolment or randomisation in the present study. 13. Participation in a clinical study of any investigational drug 30 days prior to enrolment and during the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The main objective is to compare the efficacy of quetiapine IR in patients with acute schizophrenia, schizoaffective disorder, psychosis NOS or bipolar mania with psychotic symptoms, following rapid titration versus conventional titration, by assessment of Positive and PANSS-EC at Day 5 compared with baseline at Day 1.;Secondary Objective: The secondary objectives of this study are: To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration: 1. by assessment of PANSS-EC at baseline and at Day 3 and 8. 2. by assessment of CGI at baseline and at Day 5 and 8. 3. by assessment of FAST rating scale at baseline and at Day 5 and 8. 4. by self assessment of QoL-DT at baseline and at Day 5 and 8. 5. by assessment of the sleeping pattern. 6. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of treatment failures. 7. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of the frequency of adverse events. ;Primary end point(s): The primary outcome variable of the study is the change in PANSS-EC from baseline to Day 5. | — |
Countries
Sweden
Outcome results
None listed