Status:
COMPLETED
Quetiapine Extended Release Depression Symptoms
Lead Sponsor:
AstraZeneca
Conditions:
Schizophrenia
Depression
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief 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:...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT00640562
Start Date
February 1 2008
End Date
February 1 2010
Last Update
June 19 2012
Active Locations (21)
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1
Research Site
Fermo, AP, Italy
2
Research Site
Bergamo, BG, Italy
3
Research Site
Brindisi, BR, Italy
4
Research Site
Carbonia, CA, Italy