A Study of Relapse Prevention and the Effectiveness of Long-acting Injectable Risperidone and Quetiapine Tablets in the Treatment of Patients With Schizophrenia or Schizoaffective Disorder
CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness
1 other identifier
interventional
753
22 countries
90
Brief Summary
The purpose of this study is to investigate whether a long-acting injectable formulation of risperidone provides better effectiveness over 2 years, as measured by the time to relapse, compared with quetiapine tablets in a routine psychiatric care setting. Aripiprazole will be investigated in a descriptive manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 schizophrenia
Started Oct 2004
Typical duration for phase_3 schizophrenia
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 22, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2007
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2007
CompletedResults Posted
Study results publicly available
August 10, 2010
CompletedApril 16, 2014
March 1, 2014
3.1 years
September 13, 2005
July 8, 2010
March 25, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
Relapse was defined as meeting any of the predefined criteria (adapted from Csernansky et al., 2002) on 2 consecutive evaluations during treatment, 3 to 5 days apart. The relapse rate in each treatment arm was estimated using the Kaplan-Meier method.
Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Secondary Outcomes (4)
Mean Relapse Free Period (Exploratory/Aripiprazole)
Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score
Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Week 104 or earlier)
Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score
Assessed at each visit from the moment the subject was randomized to a treatment arm (baseline visit) until the end of treatment (Month 24 or earlier)
Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores
Assessed at the moment the subject was randomized to a treatment arm (baseline visit) and after 1, 3, 6, 12, 18, and 24 months of treatment
Study Arms (3)
001
EXPERIMENTALRisperidone Long Acting Injectable (LAI) 25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.
002
ACTIVE COMPARATORQuetiapine Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.
003
OTHERAripiprazole 10-30 mg oral once daily for 104 weeks
Interventions
25 mg injection every 2 weeks until week 104. Dosage may be increased or decreased in steps of 12.5 mg. Additional oral risperidone can be administered as required until a dose increase becomes effective.
Oral tablets are titrated from 50 mg daily to 300-400 mg daily in first 4 days. Subsequently treatment is maintained for 104 weeks and dosage can be adjusted with increments or decrements of 25 to 50 mg.
Eligibility Criteria
You may qualify if:
- Diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Diseases, 4th edition (DSM-IV)
- Patients currently treated with oral risperidone, olanzapine or a conventional neuroleptic monotherapy at doses not exceeding 6 mg risperdal, 20 mg olanzapine, or a conversion dose of 10 mg haloperidol for oral conventional agents
- Patients who are stable (judged clinically stable by the investigator and on a stable dose of medication for 4 weeks or longer) but not optimally treated (non-satisfactory treatment regarding symptoms or adverse events)
You may not qualify if:
- Diagnosis other than schizophrenia or schizoaffective disorder by DSM-IV Axis I criteria
- Patients being treated with antipsychotic agents other than oral risperidone, olanzapine or conventional oral neuroleptic agents
- Patients with known hypersensitivity to oral risperidone, quetiapine, aripiprazole, or who are known non-responders to oral risperidone, quetiapine, aripiprazole or to previous treatment with at least 2 antipsychotic agents
- Patients treated with mood stabilizers or antidepressants who are not on stable dose for at least 3 months before study initiation
- Pregnant or nursing females, or those lacking adequate contraception
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (96)
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Hall in Tirol, Austria
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Linz, Austria
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Neunkirchen, Austria
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Pleven, Bulgaria
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Sofia, Bulgaria
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Sofia Sofia, Bulgaria
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Osijek, Croatia
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Rijeka, Croatia
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Split, Croatia
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Zagreb, Croatia
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Brno, Czechia
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Lnáře, Czechia
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Opava, Czechia
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Pardubice, Czechia
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Plzen Czechia, Czechia
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Prague, Czechia
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Praha 2 N/A, Czechia
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Uherský Brod, Czechia
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Ústí nad Labem, Czechia
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Middelfart, Denmark
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Vordingborg, Denmark
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Pÿrnu N/A, Estonia
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Tallinn, Estonia
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Tartu, Estonia
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Bron, France
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Brumath, France
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Créteil, France
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Dieppe, France
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Hénin-Beaumont, France
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Mont-Saint-Martin, France
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Poitiers, France
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Reims, France
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Roubaix, France
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Toulouse, France
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Augsburg, Germany
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Berlin, Germany
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Bochum, Germany
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Duisburg, Germany
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Düsseldorf, Germany
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Karlstadt am Main, Germany
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Krefeld, Germany
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München, Germany
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Oranienburg, Germany
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Stralsund, Germany
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Heraklion -Crete, Greece
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Thessalonikis, Greece
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Budapest, Hungary
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Gyõr, Hungary
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Gyula, Hungary
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Kistarcsa, Hungary
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Szeged, Hungary
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Vác, Hungary
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Cork, Ireland
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Dublin, Ireland
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Kerry, Ireland
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Sligo, Ireland
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Jerusalem, Israel
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Ramat Gan, Israel
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Tel Aviv, Israel
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Jelgava, Latvia
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Riga, Latvia
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Alytus, Lithuania
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Kaunas, Lithuania
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Klaipėda, Lithuania
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Choroszcz, Poland
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Gdynia Na, Poland
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Poznan, Poland
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Warsaw, Poland
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Coimbra, Portugal
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Porto, Portugal
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Bucharest, Romania
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Craiova, Romania
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Iași, Romania
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Khobar, Saudi Arabia
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Košice, Slovakia
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Zvolen, Slovakia
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Begunje na Gorenjskem, Slovenia
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Ljubljana, Slovenia
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Ormož, Slovenia
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Madrid, Spain
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Oviedo (Asturias), Spain
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Seville, Spain
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Valencia, Spain
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Gothenburg, Sweden
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Trollhättan, Sweden
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Ankara Turkey, Turkey (Türkiye)
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Bakirkoy/Istanbul N/A, Turkey (Türkiye)
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Istanbul, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Barnet, United Kingdom
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Barnsley, United Kingdom
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Hull, United Kingdom
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Llantrissant, United Kingdom
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Swansea, United Kingdom
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMEA Medical Affairs Director Psychiatry
- Organization
- Janssen Cilag European Medical Affairs
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- 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
September 13, 2005
First Posted
September 22, 2005
Study Start
October 1, 2004
Primary Completion
November 1, 2007
Study Completion
November 1, 2007
Last Updated
April 16, 2014
Results First Posted
August 10, 2010
Record last verified: 2014-03