Phase 3
Completed N=216
Quetiapine Extended Release Depression Symptoms
Source: ClinicalTrials.gov NCT00640562 ↗Enrolled (actual)
216
Serious AEs
3.7%
Results posted
Jun 2012
Primary outcomePrimary: Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score. — 7.31; 5.53 Score on a scale
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score. |
7.31; 5.53 | — |
| SECONDARY Change From Baseline to Week 12 of HAM-D Score |
-29.83; -23.02 | — |
| SECONDARY Change From Baseline to Week 12 of PANSS Score |
102.26; 100.51 | — |
| SECONDARY - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score |
-1.50; -1.04 | — |
| SECONDARY CGI- Global Improvement Mean Score at Week 12 |
91; 88 | — |
| SECONDARY Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score |
86.38; 76.64 | — |
| SECONDARY Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section |
2.74; 3.88 | — |
| SECONDARY Concomitant Use of Antidepressive Drugs From Baseline to Week 12 |
14; 17 | — |
| SECONDARY Change From Screening Visit to Week 12 of Prolactin Live |
61.20; 90.80 | — |
| SECONDARY Body Mass Index (BMI) at Week 12 |
29.07; 28.80 | — |
| SECONDARY Concomitant Use of Antidepressive Drugs From Baseline to Week 12 |
14; 17 | — |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT00640562). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.