Official Title: “Comparison of Quetiapine Extended-Release (Seroquel XR™) and Risperidone Int he Treatment of Depressive Symptoms, in Schizophrenic or Schizoaffective Patients: A Randomized, Open Label, Flexible-Dose, Parallel Group, Non Inferiority, 12-Week Study”

Aim of the study is to assess if the new compound Seroquel XR™ is non-inferior to Risperidone, considered as the reference drug for the treatment of depressive symptoms of schizophrenia

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Parallel Assignment, Efficacy Study

Study Primary Completion Date: May 2009

Intervention(s) in this Clinical Trial

• Drug: Quetiapine Extended Release
• Drug: Risperidone

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Active Comparator: 2

Primary Measures

• To evaluate the efficacy of Seroquel XR™ versus Risperidone on depressive symptoms assess with Calgary Depression Scale of Schizophrenia (CDSS: Addington D etal 1990), in schizophrenic or schizoaffective patients
  • Safety Issue?: No

Secondary Measures

• To evaluate the efficacy of Seroquel XR™ versus Risperidone on depressive symptoms in schizophrenic or schizoaffective patients, assessed with Hamilton Rating Scale for Depression (HAM-D; Hamilton M 1960)
  • Safety Issue?: No
• To evaluate efficacy of Seroquel XR™ vs. Risperidone on negative and positive symptoms, in schizophrenic and schizoaffective patients, assess with positive and negative Syndrome Scale (PANSS; Kay SR et al 1978)
  • Safety Issue?: No
• To evaluate efficacy of Seroquel XR™ vs. Risperidone on attitude towards treatment in schizophrenic or schizoaffective patients, assess with Drug Attitude Inventory (DAI-10; Hogan TO et al, 1983)
  • Safety Issue?: No

Inclusion Criteria:

• Provision of written informed consent
• Patients who satisfy the criteria for diagnosis of schizophrenia or schizoaffective disorder according to DSM-IVTR
• Baseline depressive symptoms, assessed by means of HAM-D (21-item) score ≥20, and HAM-D item 1 score ≥2

Exclusion Criteria:

• Any DSM-IV Axis I disorder other than schizophrenia and schizoaffective disorder
• Patients treated with depot antipsychotic medications within 1 dosing interval before day 0; patients treated with other AP oral medications during the trial except for the switch period
• Use of Clozapine within 28 days prior to enrollment or Clozapine non responders
• Any significant clinical disorder that, in the opinion of the investigator, made the subject unsuitable to be given treatment with an investigational drug
• An absolute neutrophil count (ANC) of ≤1.5 x 109 per liter
• Patients who, in the opinion of the investigator, pose an imminent risk of suicide or a danger to self or others.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Gino Montagnani, MD Study Director AstraZeneca  

Overall Contact: AstraZeneca Basiglio Clinical Study Inforamtion 02-9801-59831 

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00640562

Study ID Number: D1443L00031

ClinicalTrials.gov Identifier: NCT00640562

Health Authority: Italy: Ethics Committee