A Phase IV Prospective, Double-blind, Double-dummy, Randomised, Crossover Study to Assess the Impact on Daily Cognitive Functioning of Quetiapine Fumarate Immediate Release (Seroquel IR®) Dosed twice Daily and Quetiapine Fumarate Extended Release (Seroquel XR®) Dosed once Daily in the Evening in Patients with Stable Schizophrenia

• Conditions: Schizophrenia; MedDRA version: 12.1Level: LLTClassification code 10039626Term: Schizophrenia

• Registration Number: EUCTR2010-020579-21-AT
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-07-14
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

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

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)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified