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
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- AstraZeneca
- Enrollment
- 216
- Locations
- 1
- Primary Endpoint
- Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
Study Overview
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: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- 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.
Arms & Interventions
Quetiapine Extended Release
Intervention: Quetiapine Extended Release (Drug)
Risperidone
Intervention: Risperidone (Drug)
Outcomes
Primary Outcomes
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
Time Frame: 12 week from baseline to last visit
The CDSS scale is used to assess the level of depression in schizophrenia and to estimate the severity of depressive symptoms. CDSS has 9 items rated on four-point scale: 0=absent; 1=mild; 2=moderate; 3=severe. Anchor point descriptions are provided to aid differentiation between each item score. The first eight items are rated on basis of patients' responses to questions; the 9 item is based on clinician's assessment. The sum score is derived by adding the point score of all items (from 0 to 27 points); total score 4-5 is considered for minor depression and 6-7 score for major depression.
Secondary Outcomes
- Change From Baseline to Week 12 of HAM-D Score(12 weeks from baseline to last visit)
- Change From Baseline to Week 12 of PANSS Score(12 weeks from baseline to last visit)
- - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score(12 weeks from baseline to last visit)
- CGI- Global Improvement Mean Score at Week 12(12week: descriptive statistic of CGI by visit and treatment)
- Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score(12 week from baseline to last visit)
- Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section(12 weeks from baseline to last visit)
- Concomitant Use of Antidepressive Drugs From Baseline to Week 12(Change of drug use from baseline to last visi)
- Change From Screening Visit to Week 12 of Prolactin Live(12 week from screening visit to last visit)
- Body Mass Index (BMI) at Week 12(12 week)