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
Information source: Janssen-Cilag International NV
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Schizophrenia; Psychotic Disorders
Intervention: Aripiprazole (Drug); Risperidone Long Acting Injectable (LAI) (Drug); Quetiapine (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Janssen-Cilag International NV Official(s) and/or principal investigator(s): Janssen-Cilag International NV Clinical Trial, Study Director, Affiliation: Janssen-Cilag International NV
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.
Clinical Details
Official title: CONSTATRE: Risperdal Consta Trial Of Relapse Prevention And Effectiveness
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Mean Relapse Free Period(Risperidone LAI Versus Quetiapine)
Secondary outcome: Mean Relapse Free Period (Exploratory/Aripiprazole)Change From Baseline to Endpoint in Total Positive and Negative Syndrome Scale (PANSS) Score Change From Baseline to Endpoint in Clinical Global Impression Scale (CGI) Score Change From Baseline to Endpoint in Short-Form Health Survey 12 (SF-12) Scores
Detailed description:
Although many schizophrenia patients currently take oral antipsychotic medications, it is
estimated that up to 75% of them have difficulty adhering to the daily oral regimen.
Long-acting injectable formulations may eliminate the need for daily medication and enhance
patient compliance with the treatment regimen. This is an open-label (all people involved
know the identity of the intervention), randomized (study drug assigned by chance) study of
a formulation of risperidone (coated microspheres) injected into the muscle at 2 week
intervals over 104 weeks in stable patients with schizophrenia or schizoaffective disorder,
who are being treated with oral risperidone, olanzapine, or other conventional antipsychotic
agents. A comparator group will receive tablets of quetiapine to be taken 2 or 3 times
daily, depending on the optimal dosage. In countries where aripiprazole is available,
aripiprazole was also included in a descriptive manner. Reasons for switching
symptomatically stable patients from their current antipsychotic treatment include
insufficient effectiveness of the medication on symptoms, adverse events, or a patient's
request. The principal measure of effectiveness of the drug is the time to relapse.
Assessments of effectiveness also include: Positive and Negative Syndrome Scale (PANSS),
which measures the symptoms of schizophrenia; overall severity of illness measured by the
Clinical Global Impression subscale (CGI-S); patient's condition measured by the Clinical
Global Impression condition subscale (CGI-C); quality of life assessed by the SF-12 survey.
Safety evaluations include incidence of adverse events, Extrapyramidal Symptoms Rating Scale
(ESRS), clinical laboratory tests (biochemistry, haematology, and urinalysis), and vital
signs (pulse, blood pressure). The study hypothesis is that treatment with long-acting
risperidone injected intramuscularly every 2 weeks provides better effectiveness than
quetiapine, as measured by time to relapse, in patients with schizophrenia or
schizoaffective disorder. Risperidone injections 25mg biweekly for 104 weeks, increasing or
decreasing (increments of 12. 5mg) at investigator's discretion. Risperidone tablets (2mg
daily for 2 days) for patients starting on risperidone. Quetiapine and Aripiprazole used
according to package insert.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Locations and Contacts
Hall In Tirol, Austria
Linz, Austria
Neunkirchen, Austria
Pleven, Bulgaria
Sofia Sofia, Bulgaria
Sofia, Bulgaria
Osijek, Croatia
Rijeka, Croatia
Split, Croatia
Zagreb, Croatia
Brno, Czech Republic
Lnare, Czech Republic
Opava N/A, Czech Republic
Pardubice, Czech Republic
Plzen Czechia, Czech Republic
Praha 2 N/A, Czech Republic
Praha 8, Czech Republic
Uhersky Brod, Czech Republic
Usti Nad Labem N/A, Czech Republic
Middelfart N/A, Denmark
Vordingborg N/A, Denmark
Pÿrnu N/A, Estonia
Tallinn N/A, Estonia
Tartu N/A, Estonia
Bron N/A, France
Brumath Cedex, France
Creteil, France
Dieppe N/A, France
Henin Beaumont, France
Mont St Martin, France
Poitiers N/A, France
Reims, France
Roubaix, France
Toulouse N/A, France
Augsburg, Germany
Berlin, Germany
Bochum, Germany
Duisburg, Germany
Düsseldorf, Germany
Karlstadt, Germany
Krefeld, Germany
München, Germany
Oranienburg, Germany
Stralsund, Germany
Heraklion -Crete, Greece
Thessalonikis, Greece
Budapest N/A, Hungary
Budapest, Hungary
Gyula, Hungary
Gyõr, Hungary
Kistarcsa, Hungary
Szeged N/A, Hungary
Vac N/A, Hungary
Cork, Ireland
Dublin N/A, Ireland
Kerry, Ireland
Sligo N/A, Ireland
Jerusalem, Israel
Ramat-Gan, Israel
Tel Aviv, Israel
Jelgava, Latvia
Riga, Latvia
Alytus, Lithuania
Kaunas, Lithuania
Klaipeda, Lithuania
Siauliai, Lithuania
Vilnius, Lithuania
Choroszcz, Poland
Gdynia Na, Poland
Poznan, Poland
Warszawa, Poland
Coimbra, Portugal
Porto N/A, Portugal
Bucharest, Romania
Bucuresti, Romania
Craiova, Romania
Iasi, Romania
Al Khobar, Saudi Arabia
Kosice, Slovakia
Zvolen, Slovakia
Begunje, Slovenia
Ljubljana, Slovenia
Ormoz, Slovenia
Madrid, Spain
Oviedo (Asturias), Spain
Sevilla N/A, Spain
Valencia N/A, Spain
Göteborg, Sweden
Trollhättan, Sweden
Ankara Turkey, Turkey
Bakirkoy/Istanbul N/A, Turkey
Istanbul, Turkey
Izmir, Turkey
Barnet, United Kingdom
Barnsley, United Kingdom
Hull, United Kingdom
Llantrissant, United Kingdom
Swansea, United Kingdom
Additional Information
CONSTATRE: Risperdal� Consta� Trial of Relapse Prevention and Effectiveness RIS-SCH-3001 Study Results Synopsis
Starting date: October 2004
Last updated: March 25, 2014
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