Quetiapine Extended Release Depression Symptoms
ExAttitude
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
1 other identifier
interventional
216
1 country
21
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 schizophrenia
Started Feb 2008
21 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2008
CompletedFirst Submitted
Initial submission to the registry
March 17, 2008
CompletedFirst Posted
Study publicly available on registry
March 21, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2010
CompletedResults Posted
Study results publicly available
June 19, 2012
CompletedJune 19, 2012
May 1, 2012
2 years
March 17, 2008
March 29, 2011
May 17, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
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.
12 week from baseline to last visit
Secondary Outcomes (10)
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
- +5 more secondary outcomes
Study Arms (2)
Quetiapine Extended Release
EXPERIMENTALRisperidone
ACTIVE COMPARATORInterventions
Uptitrated starting from 300 mg in the evening on day 0, then increasing to 600 mg and up to 800 mg in the following two evenings. Previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 3 onwards it was possible to adjust the Seroquel XR dose, depending on the clinical response and tolerability of the patient, within the range of 400-800 mg per day
Uptitrated starting from 1 mg bid (morning and evening) on day 0, then increasing to 2 mg bid and up to 3 mg in the following two days. As per the other arm, previous antipsychotic was taken at the full dose on day 0, half dose on day 1 and stopped from day 2. From day 2 onwards, it was allowed to adjust he dose of Risperidone depending on the clinical response and tolerability of the patient.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (21)
Research Site
Fermo, AP, Italy
Research Site
Bergamo, BG, Italy
Research Site
Brindisi, BR, Italy
Research Site
Carbonia, CA, Italy
Research Site
Termoli, CB, Italy
Research Site
Aversa, CE, Italy
Research Site
Catania, CT, Italy
Research Site
Nicosia, EN, Italy
Research Site
Lido di Camaiore, LU, Italy
Research Site
Messina, ME, Italy
Research Site
Milazzo, ME, Italy
Research Site
Monza, MI, Italy
Research Site
Roma, Roma, Italy
Research Site
Nocera Inferiore, SA, Italy
Research Site
Vallo della Lucania, SA, Italy
Research Site
La Spezia, SP, Italy
Research Site
Collegno, TO, Italy
Research Site
Frattaminore, Italy
Research Site
Lecco, Italy
Research Site
Palermo, Italy
Research Site
Partinico, Italy
Related Publications (2)
Kasper S, Montagnani G, Trespi G, Di Fiorino M. Treatment of depressive symptoms in patients with schizophrenia: a randomized, open-label, parallel-group, flexible-dose subgroup analysis of patients treated with extended-release quetiapine fumarate or risperidone. Int Clin Psychopharmacol. 2015 Jan;30(1):14-22. doi: 10.1097/YIC.0000000000000053.
PMID: 25356632DERIVEDDi Fiorino M, Montagnani G, Trespi G, Kasper S. Extended-release quetiapine fumarate (quetiapine XR) versus risperidone in the treatment of depressive symptoms in patients with schizoaffective disorder or schizophrenia: a randomized, open-label, parallel-group, flexible-dose study. Int Clin Psychopharmacol. 2014 May;29(3):166-76. doi: 10.1097/YIC.0000000000000017.
PMID: 24681810DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Multicentre, randomized, open-label, flexible dose, parallel group, non inferiority
Results Point of Contact
- Title
- Gerard Lynch
- Organization
- AstraZeneca
Study Officials
- STUDY CHAIR
Gino Montagnani, MD
AstraZeneca
- PRINCIPAL INVESTIGATOR
Mario diFiorino
Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- LTE60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 17, 2008
First Posted
March 21, 2008
Study Start
February 1, 2008
Primary Completion
February 1, 2010
Study Completion
February 1, 2010
Last Updated
June 19, 2012
Results First Posted
June 19, 2012
Record last verified: 2012-05