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

NCT ID: NCT00216476

Last Updated: 2014-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 753 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-10-31
• Study Completion Date: 2007-11-30

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.

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.

Conditions

Schizophrenia; Psychotic Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

001

Risperidone 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.

Group Type: EXPERIMENTAL

Risperidone Long Acting Injectable (LAI)

Intervention Type: DRUG

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

Quetiapine 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.

Group Type: ACTIVE_COMPARATOR

Quetiapine

Intervention Type: DRUG

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

Aripiprazole 10-30 mg oral once daily for 104 weeks

Group Type: OTHER

Aripiprazole

Intervention Type: DRUG

10-30 mg oral once daily for 104 weeks

Interventions

Aripiprazole

10-30 mg oral once daily for 104 weeks

Intervention Type: DRUG

Risperidone 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.

Intervention Type: DRUG

Quetiapine

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Janssen-Cilag International NV Clinical Trial

Role: STUDY_DIRECTOR

Janssen-Cilag International NV

Locations

Hall in Tirol, , Austria

Linz, , Austria

Neunkirchen, , Austria

Pleven, , Bulgaria

Sofia, , Bulgaria

Sofia Sofia, , Bulgaria

Osijek, , Croatia

Rijeka, , Croatia

Split, , Croatia

Zagreb, , Croatia

Brno, , Czechia

Lnáře, , Czechia

Opava, , Czechia

Pardubice, , Czechia

Plzen Czechia, , Czechia

Prague, , Czechia

Praha 2 N/A, , Czechia

Uherský Brod, , Czechia

Ústí nad Labem, , Czechia

Middelfart, , Denmark

Vordingborg, , Denmark

Pÿrnu N/A, , Estonia

Tallinn, , Estonia

Tartu, , Estonia

Bron, , France

Brumath, , France

Créteil, , France

Dieppe, , France

Hénin-Beaumont, , France

Mont-Saint-Martin, , France

Poitiers, , France

Reims, , France

Roubaix, , France

Toulouse, , France

Augsburg, , Germany

Berlin, , Germany

Bochum, , Germany

Duisburg, , Germany

Düsseldorf, , Germany

Karlstadt am Main, , Germany

Krefeld, , Germany

München, , Germany

Oranienburg, , Germany

Stralsund, , Germany

Heraklion -Crete, , Greece

Thessalonikis, , Greece

Budapest, , Hungary

Gyõr, , Hungary

Gyula, , Hungary

Kistarcsa, , Hungary

Szeged, , Hungary

Vác, , Hungary

Cork, , Ireland

Dublin, , Ireland

Kerry, , Ireland

Sligo, , Ireland

Jerusalem, , Israel

Ramat Gan, , Israel

Tel Aviv, , Israel

Jelgava, , Latvia

Riga, , Latvia

Alytus, , Lithuania

Kaunas, , Lithuania

Klaipėda, , Lithuania

Šiauliai, , Lithuania

Vilnius, , Lithuania

Choroszcz, , Poland

Gdynia Na, , Poland

Poznan, , Poland

Warsaw, , Poland

Coimbra, , Portugal

Porto, , Portugal

Bucharest, , Romania

Craiova, , Romania

Iași, , Romania

Khobar, , Saudi Arabia

Košice, , Slovakia

Zvolen, , Slovakia

Begunje na Gorenjskem, , Slovenia

Ljubljana, , Slovenia

Ormož, , Slovenia

Madrid, , Spain

Oviedo (Asturias), , Spain

Seville, , Spain

Valencia, , Spain

Gothenburg, , Sweden

Trollhättan, , Sweden

Ankara Turkey, , Turkey (Türkiye)

Bakirkoy/Istanbul N/A, , Turkey (Türkiye)

Istanbul, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Barnet, , United Kingdom

Barnsley, , United Kingdom

Hull, , United Kingdom

Llantrissant, , United Kingdom

Swansea, , United Kingdom

Countries

Austria; Bulgaria; Croatia; Czechia; Denmark; Estonia; France; Germany; Greece; Hungary; Ireland; Israel; Latvia; Lithuania; Poland; Portugal; Romania; Saudi Arabia; Slovakia; Slovenia; Spain; Sweden; Turkey (Türkiye); United Kingdom

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=46&filename=CR002269_CSR.pdf

CONSTATRE: Risperdal� Consta� Trial of Relapse Prevention and Effectiveness RIS-SCH-3001 Study Results Synopsis

Other Identifiers

CR002269

Identifier Type: -

Identifier Source: org_study_id