Quetiapine Extended Release Depression Symptoms

• Status: Completed
• Trial end date: 2010-02-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: AstraZeneca
• Treatments: Quetiapine Fumarate; Risperidone

Criteria

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.