Quetiapine Extended Release Depression Symptoms (ExAttitude)

AstraZeneca

Status and phase

Completed

Phase 3

Conditions

Schizophrenia

Depression

Treatments

Drug: Risperidone

Drug: Quetiapine Extended Release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00640562

D1443L00031

Details and patient eligibility

About

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.

Enrollment

216 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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.