Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
216 participants
INTERVENTIONAL
2008-02-29
2010-02-28
Brief Summary
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PLEASE NOTE: Seroquel SR and Seroquel XR refer to the same formulation. The SR designation was changed to XR after consultation with FDA.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Quetiapine Extended Release
Quetiapine Extended Release
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
Risperidone
Risperidone
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.
Interventions
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Quetiapine Extended Release
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
Risperidone
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
65 Years
ALL
No
Sponsors
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AstraZeneca
INDUSTRY
Responsible Party
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Principal Investigators
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Gino Montagnani, MD
Role: STUDY_CHAIR
AstraZeneca
Mario diFiorino
Role: PRINCIPAL_INVESTIGATOR
Ospedale Unico della Versilia (Lido di Camaiore, Lucca Italy)
Locations
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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
Countries
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References
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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.
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.
Other Identifiers
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D1443L00031
Identifier Type: -
Identifier Source: org_study_id
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