Quetiapine Extended Release Depression Symptoms - ExAttitude

Study identifier:D1443L00031

ClinicalTrials.gov identifier:N/A

EudraCT identifier:N/A

CTIS identifier:N/A

Study Complete

Official Title

Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone in the treatment of depressive symptoms, in schizophrenic or schizoaffective patients: A randomized, open label, flexible-dose, parallel group, non inferiority, 12-week study

Medical condition

schizophrenia

Phase

Phase 3

Healthy volunteers

Study drug

Quetiapine Extended Release, Risperidone

Sex

All

Actual Enrollment

216

Study type

Interventional

Age

18 Years - 65 Years

Date

Study Start Date: 01 Feb 2008

Primary Completion Date: 01 Feb 2010

Study Completion Date: 01 Feb 2010

Study design

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Verification:

Verified 01 May 2012 by AstraZeneca Pharmaceuticals

Collaborators

Inclusion and exclusion criteria

No locations available

Arms	Assigned Interventions
Experimental: Quetiapine Extended Release	Drug: Quetiapine Extended Release Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day Other Name: Seroquel XR™
Active Comparator: Risperidone	Drug: Risperidone Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient. Other Name: Risperdal

Arms

Assigned Interventions

Experimental: Quetiapine Extended Release

Drug: Quetiapine Extended Release
Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day

Other Name: Seroquel XR™

Active Comparator: Risperidone

Drug: Risperidone
Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.

Other Name: Risperdal

Documents available

https://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_MED_6111&studyid=262&filename=CSR-D1443L00031.pdf
Download
CSR-D1443L00031.pdf
Download
Trial Results Summaries
Available here

Contacts

Contact

AstraZeneca Basiglio Clinical Study Inforamtion

02-9801-59831

Investigators

Principal Investigator

Gino Montagnani

AstraZeneca