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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


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.


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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

Page last updated: August 23, 2015

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