Compare the effect on cognitive functioning of two formulations of Seroquel, Seroquel XR and IR in patients with stable schizophrenia - eXtRa

Study identifier:D1443L00082

ClinicalTrials.gov identifier:N/A

EudraCT identifier:2010-020579-21

CTIS identifier:N/A

Study Complete

Official Title

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

Medical condition

schizophrenia

Phase

Phase 4

Healthy volunteers

Study drug

Seroquel XR- quetiapine fumarate extended release, Seroquel IR - quetiapine fumarate, Placebo matching Seroquel XR, Placebo matching Seroquel IR

Sex

All

Actual Enrollment

Study type

Interventional

Age

18 Years - 50 Years

Date

Study Start Date: 01 Nov 2010

Primary Completion Date: 01 Aug 2011

Study Completion Date: 01 Aug 2011

Study design

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind
Primary Purpose: Treatment

Verification:

Verified 01 May 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

Inclusion Criteria

- Provision of written informed consent prior to any study specific procedures
- 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 (DSM-IV, American Psychiatric Association 2000) criteria of schizophrenia (DSM-IV codes 295.3) confirmed by MINI version 5.0
- Outpatient status at enrolment
- Dose of quetiapine IR or quetiapine XR unchanged during the last 56 days before randomisation

Exclusion Criteria

- 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.
- Previous stable use of high dosage of benzodiazepines during one year or more
- Significant neurological medical history (complicated head trauma as judged by the investigator, epilepsy, meningo-encephalitis)
- Use of the following medication:
- other antipsychotic drug than quetiapine within 28 days prior to randomisation
- a depot antipsychotic injection within two dosing intervals (for the depot) before randomisation (Visit 2)
- other psychoactive drugs within 14 days prior to randomisation (hypnotic or anxiolytic drugs, other than those allowed)
- Use of concomitant therapy likely to affect cognition, Medication prohibited 28 days prior to randomisation: benzodiazepines, amphetamines, reboxitin, atomoxinetine, buspiron, donepezil, duloxetine, galantamine, ginko biloba, memantine, methylphenidate, modafinil, rivastigmine,
tacrine, smoking cessation therapy varencicline and any dosage form of nicotine replacement therapy. Medication prohibited 14 days prior to randomisation: irreversible monoamine oxidase inhibitors (MAOI), tricyclic antidepressants (TCA), biperiden, antoicholinergic agents (even if the indications are extra pyramidal symptoms or urinary symptoms)

No locations available

Arms	Assigned Interventions
Active Comparator: First Seroquel XR then Seroquel IR Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days	Drug: Seroquel XR- quetiapine fumarate extended release Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient’s dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days. Drug: Seroquel IR - quetiapine fumarate Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days. Drug: Placebo matching Seroquel XR Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. Drug: Placebo matching Seroquel IR Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.
Active Comparator: First Seroquel IR then Seroquel XR Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days	Drug: Seroquel XR- quetiapine fumarate extended release Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient’s dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days. Drug: Seroquel IR - quetiapine fumarate Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days. Drug: Placebo matching Seroquel XR Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days. Drug: Placebo matching Seroquel IR Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Arms

Assigned Interventions

Active Comparator: First Seroquel XR then Seroquel IR
Patients randomised to Seroquel XR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel IR for 10-16 days

Drug: Seroquel XR- quetiapine fumarate extended release
Seroquel XR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient’s dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken once a day for 10-16 days.

Drug: Seroquel IR - quetiapine fumarate
Seroquel IR dose 400-700 mg (in tablet form). The investigator established the dosing schedule for each patient depending on the patient's dose when entering the study. The patients continued on the same dose during the study as they had prior to enrolment. Dose taken twice a day for 10-16 days.

Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.

Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Active Comparator: First Seroquel IR then Seroquel XR
Patients randomised to Seroquel IR will have treatment for 10-16 days and after that cross-over to treatment with Seroquel XR for 10-16 days

Drug: Placebo matching Seroquel XR
Placebo matching Seroquel XR dose 400-700 mg (in tablet form). Dose taken once a day for 10-16 days.

Drug: Placebo matching Seroquel IR
Placebo matching Seroquel IR dose 400-700 mg (in tablet form). Dose taken twice a day for 10-16 days.

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=273&filename=CSR-D1443L00082.pdf
Download
CSR-D1443L00082.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Clinical Study Information

+46 8 553 26000

Investigators

Principal Investigator

Eva Dencker Vansvik

AstraZeneca