An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia

NCT ID: NCT00460512

Last Updated: 2025-04-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1814 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-04-25
• Study Completion Date: 2020-03-04

Brief Summary

The purpose of this study is to explore tolerability, safety and effectiveness of flexibly dosed paliperidone extended release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) previously unsuccessfully treated with an oral antipsychotic medication.

Detailed Description

This is a non-randomized (the study drug is not assigned by chance), single arm, multicenter (when more than one hospital or medical school team work on a medical research study) 6-month study. Participants can be transitioned to an effective dose of paliperidone ER from any oral antipsychotic medication due to lack of efficacy, lack of tolerability or safety, lack of compliance or other reason. A transition period of maximum 4 weeks will be allowed. Throughout the study, participants will receive flexible dose of 3 to 12 milligram (mg) of paliperidone once daily orally for 6 months. Adjustment of the dosage will be done at Investigator's discretion, based on the individual participant's clinical response and tolerability of the study drug dosages. Participants who complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available. The starting dose of the extension phase will be the same as at the end of the 6-month study and may be changed throughout the extension period. The extension phase will consist of a main extension phase (ending with an End of Main Extension Phase Visit) and a modified extension phase (ending with an End of Study Visit). Efficacy will primarily be evaluated by positive and negative syndrome scale (PANSS). Safety will primarily be evaluated by Extrapyramidal Symptom Rating Scale (ESRS).

Conditions

Schizophrenia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paliperidone Extended Release (ER)

Group Type: EXPERIMENTAL

Paliperidone ER

Intervention Type: DRUG

Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons.

Interventions

Paliperidone ER

Paliperidone ER tablet in dose range of 3 to12 milligram (mg) per day was given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics due to lack of efficacy, lack of tolerability, lack of compliance or other reasons.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Participant meets the Diagnostic and Statistical Manual of Mental Disorders (Edition 4) criteria for schizophrenia
• Participant is previously non-acute (on the same antipsychotic medication used for the treatment of schizophrenia and Clinical Global Impression-Severity [CGI-S] change less than or equal to 1 in the past 4 weeks before enrollment) and has been given an adequate dose of an appropriate oral antipsychotic for an adequate period of time prior to enrollment, but previous treatment is considered unsuccessful due to one or more of the following reasons: lack of effectiveness, lack of tolerability or safety, lack of compliance and/or other reasons to switch to another antipsychotic medication
• Participant is healthy on the basis of a physical examination and vital signs at screening
• Female participants must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
• Participants must be willing and able to fill out self-administered questionnaires

Exclusion Criteria

• Participants on clozapine, any conventional depot neuroleptic or risperidone long-acting injection during the last 3 months
• Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
• Participants with history or current symptoms of tardive dyskinesia (twitching or jerking movements that you cannot control in your face, tongue, or other parts of your body) and neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
• Participants judged to be at high risk for adverse events, violence or self-harm
• Participants with a current use or known history (over the past 6 months) of substance dependence according to Diagnostic and Statistical Manual of Mental Disorders (Edition 4) Criteria

• 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

Antwerp, , Belgium

Bertrix, , Belgium

Dave, , Belgium

Diest, , Belgium

Duffel, , Belgium

Kortenberg, , Belgium

Liège, , Belgium

Montignies-sur-Sambre, , Belgium

Mortsel, , Belgium

Roeselare, , Belgium

Saint Denijs-Westrem, , Belgium

Saint-Servais, , Belgium

Sint-Truiden, , Belgium

Tielt, , Belgium

Waregem, , Belgium

Bulgaria, , Bulgaria

Sofia, , Bulgaria

Tzerova Korya, , Bulgaria

Osijek, , Croatia

Rijeka, , Croatia

Split, , Croatia

Zagreb, , Croatia

Aalborg, , Denmark

Elsinore, , Denmark

Risskov, , Denmark

Viby J, , Denmark

Ekenäs, , Finland

Helsinki, , Finland

Raahe, , Finland

Tampere, , Finland

Bar-le-Duc, , France

Bordeaux, , France

Bourg-en-Bresse, , France

Bully-les-Mines, , France

Caen, , France

Chambéry, , France

Clermont-Ferrand, , France

Créteil, , France

Dijon, , France

Dole, , France

Henin Baumont, , France

Jarnac, , France

La Roche-sur-Yon, , France

La Seyne-sur-Mer, , France

Mont-Saint-Martin, , France

Montpellier, , France

Nîmes, , France

Paris, , France

Pau, , France

Rennes, , France

Roubaix, , France

Saint-Avé, , France

Saint-Cyr-au-Mont-d'Or, , France

Saint-Germain-en-Laye, , France

Villejuif, , France

Aalen, , Germany

Achim, , Germany

Augsburg, , Germany

Bamberg, , Germany

Bergfelde, , Germany

Bergheim, , Germany

Berlin, , Germany

Bochum, , Germany

Butzbach, , Germany

Chemnitz, , Germany

Coesfeld, , Germany

Cologne, , Germany

Darmstadt, , Germany

Dillingen, , Germany

Dresden, , Germany

Duisburg, , Germany

Düsseldorf, , Germany

Ebensfeld, , Germany

Eberbach, , Germany

Ellwangen, , Germany

Elmshorn, , Germany

Essen, , Germany

Ettlingen, , Germany

Freiburg im Breisgau, , Germany

Gelnhausen, , Germany

Gelsenkirchen, , Germany

Giessen, , Germany

Göttingen, , Germany

Haina, , Germany

Halle, , Germany

Hamburg, , Germany

Hanover, , Germany

Hattingen, , Germany

Hemer, , Germany

Hemmoor, , Germany

Heppenheim an der Bergstrasse, , Germany

Idar-Oberstein, , Germany

Jena, , Germany

Kaufbeuren, , Germany

Königsbrück, , Germany

Krefeld, , Germany

Leipzig, , Germany

Liebenburg, , Germany

Lüdenscheid, , Germany

Mainz, , Germany

Mannheim, , Germany

Mittweida, , Germany

München, , Germany

Münster, , Germany

Naumburg, , Germany

Norden, , Germany

Nuremberg, , Germany

Ober-Ramstadt, , Germany

Oldenburg, , Germany

Oranienburg, , Germany

Ostfildern, , Germany

Potsdam, , Germany

Rostock, , Germany

Saalfeld, , Germany

Salzgitter, , Germany

Schlüchtern, , Germany

Siegen, , Germany

Spremberg, , Germany

Stralsund, , Germany

Straubing, , Germany

Ulm, , Germany

Viersen, , Germany

Wasserburg, , Germany

Wiesbaden, , Germany

Wiesloch, , Germany

Wilhelmshaven, , Germany

Wismar, , Germany

Würzburg, , Germany

Athens, , Greece

Chios, , Greece

Heraklion, , Greece

Larissa, , Greece

Thessalonikis, , Greece

Balassagyarmat, , Hungary

Budapest, , Hungary

Kecskemét, , Hungary

Sopron, , Hungary

Bat Yam, , Israel

Be'er Ya'acov, , Israel

Jerusalem, , Israel

Pardesiyya, , Israel

Daugavpils, , Latvia

Jelgava, , Latvia

Liepāja, , Latvia

Riga, , Latvia

Strenči, , Latvia

Kaunas, , Lithuania

Panevezys, , Lithuania

Vilnius, , Lithuania

Assen, , Netherlands

Beilen, , Netherlands

Bennebroek, , Netherlands

Enschede, , Netherlands

Groningen, , Netherlands

Hoofddorp, , Netherlands

Leeuwarden, , Netherlands

The Hague, , Netherlands

Tilburg, , Netherlands

Zwolle, , Netherlands

Bydgoszcz, , Poland

Gdynia Na, , Poland

Krakow Na, , Poland

Lubliniec, , Poland

Skorzewo Na, , Poland

Angra do Heroísmo, , Portugal

Braga, , Portugal

Castelo Viegas, , Portugal

Coimbra, , Portugal

Lisbon, , Portugal

Porto, , Portugal

Kazan', , Russia

Krasnodar, , Russia

Moscow, , Russia

Moscow Russia, , Russia

Saint Peterburg Na, , Russia

Saint Petersburg, , Russia

Saratov, , Russia

Yaroslavl, , Russia

Belgrade, , Serbia

Kragujevac, , Serbia

Novi Sad, , Serbia

Alicante, , Spain

Barcelona, , Spain

Bunyola Illes Balears, , Spain

Burgos, , Spain

Oviedo, , Spain

Pontevedra, , Spain

Sama de Langreo Asturias, , Spain

Valencia, , Spain

Zamora, , Spain

Zaragoza, , Spain

Bromma, , Sweden

Gothenburg, , Sweden

Hudiksvall, , Sweden

Karlskrona, , Sweden

Malmo, , Sweden

Mölndal, , Sweden

Norrtälje, , Sweden

Nyköping, , Sweden

Simrishamn, , Sweden

Skövde, , Sweden

Solna, , Sweden

Trollhättan, , Sweden

Västra Frölunda, , Sweden

Aarau, , Switzerland

Basel, , Switzerland

Basel Bs, , Switzerland

Biel/Bienne, , Switzerland

Geneva, , Switzerland

Lenzburg, , Switzerland

Liestal, , Switzerland

Marsens, , Switzerland

Montreux, , Switzerland

Münsingen, , Switzerland

Oetwil, , Switzerland

Riehen, , Switzerland

Sarnen, , Switzerland

Solothurn, , Switzerland

Viganello, , Switzerland

Zurich, , Switzerland

Ankara, , Turkey (Türkiye)

Denizli, , Turkey (Türkiye)

Diyarbakır, , Turkey (Türkiye)

Gaziantep, , Turkey (Türkiye)

Izmir, , Turkey (Türkiye)

Barnet, , United Kingdom

Birmingham, , United Kingdom

Clacton-on-Sea, , United Kingdom

Devon, , United Kingdom

Exeter, , United Kingdom

Glasgow, , United Kingdom

Countries

Belgium; Bulgaria; Croatia; Denmark; Finland; France; Germany; Greece; Hungary; Israel; Latvia; Lithuania; Netherlands; Poland; Portugal; Russia; Serbia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

Schreiner A, Lahaye M, Peuskens J, Naber D, Dilbaz N, Millet B, Franco MA, Rancans E, Turczynski J, Smeraldi E, Lara E, Neznanov NG. Paliperidone extended-release in patients with non-acute schizophrenia previously unsuccessfully treated with other oral antipsychotics. Expert Opin Pharmacother. 2014 Apr;15(5):593-603. doi: 10.1517/14656566.2014.884071. Epub 2014 Feb 3.

Reference Type: RESULT

PMID: 24491033 (View on PubMed)

Other Identifiers

R076477SCH3017

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004265-34

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR012949

Identifier Type: -

Identifier Source: org_study_id