Clinical trial NCT00640562: Quetiapine Extended Release Depression Symptoms
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Depression
Keywords: Schizophrenia
Depression
Quetiapine
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-21
Enrollment: 216
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Change From Baseline to Week 12 of Calgary Depression Scale for Schizophrenia (CDSS) Score.
timeFrame: 12 week from baseline to last visit
Secondary outcomes:
measure: Change From Baseline to Week 12 of HAM-D Score
timeFrame: 12 weeks from baseline to last visit
measure: Change From Baseline to Week 12 of PANSS Score
timeFrame: 12 weeks from baseline to last visit
measure: - Change From Baseline to Week 12 of Clinical Global Impression (CGI- Severity of Illness) Score
timeFrame: 12 weeks from baseline to last visit
measure: CGI- Global Improvement Mean Score at Week 12
timeFrame: 12week: descriptive statistic of CGI by visit and treatment
measure: Change From Baseline to Week 12 of Drug Attitude Inventory 10 Item Scale (DAI 10) Score
timeFrame: 12 week from baseline to last visit
measure: Change From Baseline in the Simpson Angus Scale (SAS) Total Score to Week 12 as an Indication of Neurological Side Effects Section
timeFrame: 12 weeks from baseline to last visit
measure: Concomitant Use of Antidepressive Drugs From Baseline to Week 12
timeFrame: 12 week from baseline to last visi
measure: Change From Screening Visit to Week 12 of Prolactin Live
timeFrame: 12 week from screening visit to last visit
measure: Body Mass Index (BMI) at Week 12
timeFrame: 12 week
measure: Concomitant Use of Antidepressive Drugs From Baseline to Week 12
timeFrame: Change of drug use from baseline to last visi
Other outcomes:
Locations:
city: Fermo
country: Italy
facility: Research Site
state: AP
city: Bergamo
country: Italy
facility: Research Site
state: BG
city: Brindisi
country: Italy
facility: Research Site
state: BR
city: Carbonia
country: Italy
facility: Research Site
state: CA
city: Termoli
country: Italy
facility: Research Site
state: CB
city: Aversa
country: Italy
facility: Research Site
state: CE
city: Catania
country: Italy
facility: Research Site
state: CT
city: Nicosia
country: Italy
facility: Research Site
state: EN
city: Lido Di Camaiore
country: Italy
facility: Research Site
state: LU
city: Messina
country: Italy
facility: Research Site
state: ME
city: Milazzo
country: Italy
facility: Research Site
state: ME
city: Monza
country: Italy
facility: Research Site
state: MI
city: Nocera Inferiore
country: Italy
facility: Research Site
state: SA
city: Vallo Della Lucania
country: Italy
facility: Research Site
state: SA
city: La Spezia
country: Italy
facility: Research Site
state: SP
city: Collegno
country: Italy
facility: Research Site
state: TO
city: Frattaminore
country: Italy
facility: Research Site
city: Lecco
country: Italy
facility: Research Site
city: Palermo
country: Italy
facility: Research Site
city: Partinico
country: Italy
facility: Research Site
city: Roma
country: Italy
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Gino Montagnani, MD
role: STUDY_CHAIR
affiliation: Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
name: Mario diFiorino
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Di 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.