Acute Schizophrenia and Schizoaffective Disorder
Conditions
Interventions
Trade Name: Seroquel IR Tablets
Product Name: Seroquel IR Tablets
Product Code: PL 17901/0038-0041 & PL 17901/0088
Pharmaceutical Form: Film-coated tabl
Sponsors
AstraZeneca UK Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: For inclusion in the study treatment phase, subjects must fulfil all of the following criteria: 1. Provision of informed, written consent (or relative or carer assent, if the subject has been assessed as not capable of providing informed, written consent). 2. Male or female, aged 18-65 years. 3. In the opinion of the Investigator, requirement for treatment for an acute episode of schizophrenia or schizoaffective disorder (according to DSM-IV diagnostic criteria). 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: Any of the following is regarded as a criterion for exclusion from the study: 1. In-patients who, it is anticipated, will be discharged before the end of the titration period (Day 4). 2. Subjects who are considered to be treatment resistant to antipsychotic medication, according to the Kane criteria (Kane et al 1988) (i.e. lack of significant symptom relief after two standard antipsychotic medications, from different classes, after 6 weeks of treatment with a dose equivalent to chlorpromazine 1000 mg per day). 3. Subjects with relevant clinical disease (renal or hepatic impairment; cardiovascular disease or cerebrovascular disease; diabetes mellitus or risk factors for the development of diabetes mellitus; history of seizures), or other significant or unstable disease, including malignancy, as judged by the Investigator. 4. History of multiple episodes of syncope, or significant orthostatic hypotension, as judged by the Investigator. 5. Clinically abnormal ECG at Visit 1 as determined by the Investigator. 6. An absolute neutrophil count (ANC) of =1.5 x 109 per liter at Visit 1. 7. Administration of concomitant antipsychotic medication during the study including, but not limited to, the following: · Atypical antipsychotics: amisulpride, aripiprazole, clozapine, olanzapine, risperidone and zotepine · Typical antipsychotics: chlorpromazine, fluperitixol, fluphenazine, haloperidol, levomepromazine, pericyazine, perphenazine, pimozide, pipotiazine, prochlorperazine, sulpiride, trifluoperazine, and zucloperithixol. NB: The dosing cycle for depot medication must have completed, and treatment with clozapine must have stopped at least 28 days previously, in order for a subject to be enrolled. 8. Administration of hepatic enzyme inducers / inhibitors in the 14 days preceding enrolment into the study, or concomitant use during the study, including 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 and saquinavir
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The objectives of this study are to evaluate the efficacy and tolerability of quetiapine IR (Immediate Release), over 14 days, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration up to a maximum daily dose of 800 mg. The primary objective of this study is to compare the efficacy of quetiapine IR, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration, by assessment of Positive and Negative Syndrome Scale (PANSS) at Day 7. ; Secondary Objective: The secondary objectives of the study are: 1. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by assessment of PANSS at Day 5 and 14. 2. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by evaluation of PANSS excitatory subscale (PANSS-EC) at Day 5, 7 and 14. 3. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by evaluation of PANSS negative, positive and general subscales at Day 5, 7 and 14. 4. To compare the efficacy of quetiapine IR, following rapid titration versus conventional titration, by assessment of Clinical Global Impression – Severity (CGI-S) and Clinical Global Impression – Improvement (CGI-I) at Day 5, 7 and 14. 5. To compare the tolerability of quetiapine IR, following rapid titration versus conventional titration, by assessment of vital signs and the frequency and severity of adverse events. ;Primary end point(s): The primary objective of this study is to compare the efficacy of quetiapine IR, in subjects with acute schizophrenia or schizoaffective disorder, following rapid titration versus conventional titration, by assessment of Positive and Negative Syndrome Scale (PANS | — |
Countries
United Kingdom
Outcome results
None listed