Schizophrenia MedDRA version: 12.1 Level: LLT Classification code 10039626 Term: Schizophrenia
Conditions
Interventions
Trade Name: Seroquel
Product Name: Seroquel
Pharmaceutical Form: Tablet
INN or Proposed INN: QUETIAPINE
CAS Number: 111974697
Concentration unit: mg milligram(s)
Concentration type: equal
Concentratio
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Provision of written informed consent prior to any study specific procedures 2.Male and female patients aged 18 and 50 years 3. Documented clinical diagnosis of schizophrenia, paranoid type, for at least 2 years before randomisation meeting the Diagnostic and Statistical Manual of Mental Disorders, 4th Edition, Text Revision (DSM-IV-TR, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.30) confirmed by MINI version 5.0 4. Outpatient status at enrolment 5. 56 days period (8 weeks) of stable psychiatric status before randomisation 6.Treated with quetiapine IR or quetiapine XR in a dose range between 400-750 mg 7.Treated with quetiapine IR or quetiapine XR in a dose range between 400-750 mg 8.Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation 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. Diagnosis of any DSM-IV Axis I disorder other than those included in inclusion criteria above within 6 months before randomisation (e.g., alcohol dependence or psychoactive substance dependence not in full remission, concurrent organic mental disorder, or mental retardation [axis II diagnosis]) of a degree that may interfere with the patient’s ability to co-operate. 2. Patients with substance abuse or dependence as defined by DSM-IV-TR criteria and not in full remission or if previous substance abuse or dependence have caused impaired cognition. A urine drug screen test will be performed at enrolment. The investigator will evaluate the toxicology results along with medical history to determine if the patient meets in DSM-IV-TR criteria for substance abuse. Patients are excluded with a single urine toxicology screen (UTS) positive for cocaine, heroin, or PCP 3. Last schizophrenic episode with disorganized (DSM-IV code 295.10), catatonic (DSM-IV code 295.20), residual (DSM-IV code 295.60) type, or undifferentiated type (295.90)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to demonstrate that patients with stable schizophrenia show superior daytime cognitive performance when taking quetiapine XR once daily in the evening compared to taking quetiapine IR twice daily by using the CogState Test domains Detection (speed of processing) and Identification (attention/vigilance).;Secondary Objective: • To assess the safety and tolerability during treatment with quetiapine XR and treatment with quetiapine IR in patients with stable schizophrenia by incidence of AEs and changes in laboratory values, vital signs and weight from enrolment to end of study • To assess treatment satisfaction for patients with stable schizophrenia on quetiapine XR and quetiapine IR by using the Treatment Satisfaction Questionnaire of Medication (TSQM) • To assess differences in daytime cognitive performance with quetiapine IR and XR using CogState: o working memory o verbal learning o reasoning and problem solving ;Primary end point(s): The primary outcome variable is the relative performance in CogState Cognition Testing, Detection task (speed of processing) and Identification task (attention/vigilance) based on a standardized composite score from patients taking quetiapine XR once daily in the evening versus quetiapine IR twice daily. The composite change score can then be derived from scores on each of the tasks. | — |
Countries
Austria, Denmark, Germany, Italy, Spain
Outcome results
None listed