An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
PERFlexS
An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
3 other identifiers
interventional
1,814
21 countries
228
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.
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 Apr 2007
Longer than P75 for phase_3 schizophrenia
228 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 13, 2007
CompletedFirst Posted
Study publicly available on registry
April 16, 2007
CompletedStudy Start
First participant enrolled
April 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 22, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
March 4, 2020
CompletedApril 27, 2025
April 1, 2025
1.7 years
April 13, 2007
April 25, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score in Those Participants who Transitioned due to Lack of Efficacy
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent) to 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.
Baseline and endpoint (up to Week 26)
Secondary Outcomes (9)
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26)
Baseline and endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Endpoint (up to Week 26)
Baseline and endpoint (up to Week 26)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
Baseline and endpoint (up to Week 26)
Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
Baseline and endpoint (up to Week 26)
- +4 more secondary outcomes
Study Arms (1)
Paliperidone Extended Release (ER)
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (231)
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Antwerp, Belgium
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Bertrix, Belgium
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Dave, Belgium
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Diest, Belgium
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Duffel, Belgium
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Kortenberg, Belgium
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Liège, Belgium
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Montignies-sur-Sambre, Belgium
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Mortsel, Belgium
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Roeselare, Belgium
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Saint Denijs-Westrem, Belgium
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Saint-Servais, Belgium
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Sint-Truiden, Belgium
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Tielt, Belgium
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Waregem, Belgium
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Bulgaria, Bulgaria
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Sofia, Bulgaria
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Tzerova Korya, 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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Aalborg, Denmark
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Elsinore, Denmark
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Risskov, Denmark
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Viby J, Denmark
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Ekenäs, Finland
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Helsinki, Finland
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Raahe, Finland
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Tampere, Finland
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Bar-le-Duc, France
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Bordeaux, France
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Bourg-en-Bresse, France
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Bully-les-Mines, France
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Caen, France
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Chambéry, France
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Clermont-Ferrand, France
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Créteil, France
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Dijon, France
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Dole, France
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Henin Baumont, France
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Jarnac, France
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La Roche-sur-Yon, France
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La Seyne-sur-Mer, France
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Mont-Saint-Martin, France
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Montpellier, France
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Nîmes, France
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Paris, France
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Pau, France
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Rennes, France
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Roubaix, France
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Saint-Avé, France
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Saint-Cyr-au-Mont-d'Or, France
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Saint-Germain-en-Laye, France
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Villejuif, France
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Aalen, Germany
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Achim, Germany
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Augsburg, Germany
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Bamberg, Germany
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Bergfelde, Germany
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Bergheim, Germany
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Berlin, Germany
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Bochum, Germany
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Butzbach, Germany
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Chemnitz, Germany
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Coesfeld, Germany
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Cologne, Germany
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Darmstadt, Germany
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Dillingen, Germany
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Dresden, Germany
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Duisburg, Germany
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Düsseldorf, Germany
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Ebensfeld, Germany
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Eberbach, Germany
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Ellwangen, Germany
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Elmshorn, Germany
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Essen, Germany
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Ettlingen, Germany
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Freiburg im Breisgau, Germany
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Gelnhausen, Germany
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Gelsenkirchen, Germany
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Giessen, Germany
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Göttingen, Germany
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Haina, Germany
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Halle, Germany
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Hamburg, Germany
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Hanover, Germany
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Hattingen, Germany
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Hemer, Germany
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Hemmoor, Germany
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Heppenheim an der Bergstrasse, Germany
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Idar-Oberstein, Germany
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Jena, Germany
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Kaufbeuren, Germany
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Königsbrück, Germany
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Krefeld, Germany
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Leipzig, Germany
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Liebenburg, Germany
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Lüdenscheid, Germany
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Mainz, Germany
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Mannheim, Germany
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Mittweida, Germany
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München, Germany
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Münster, Germany
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Naumburg, Germany
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Norden, Germany
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Nuremberg, Germany
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Ober-Ramstadt, Germany
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Oldenburg, Germany
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Oranienburg, Germany
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Ostfildern, Germany
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Potsdam, Germany
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Rostock, Germany
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Saalfeld, Germany
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Salzgitter, Germany
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Schlüchtern, Germany
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Siegen, Germany
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Spremberg, Germany
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Stralsund, Germany
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Straubing, Germany
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Ulm, Germany
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Viersen, Germany
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Wasserburg, Germany
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Wiesbaden, Germany
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Wiesloch, Germany
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Wilhelmshaven, Germany
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Wismar, Germany
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Würzburg, Germany
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Athens, Greece
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Chios, Greece
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Heraklion, Greece
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Larissa, Greece
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Thessalonikis, Greece
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Balassagyarmat, Hungary
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Budapest, Hungary
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Kecskemét, Hungary
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Sopron, Hungary
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Bat Yam, Israel
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Be'er Ya'acov, Israel
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Jerusalem, Israel
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Pardesiyya, Israel
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Daugavpils, Latvia
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Jelgava, Latvia
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Liepāja, Latvia
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Riga, Latvia
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Strenči, Latvia
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Kaunas, Lithuania
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Panevezys, Lithuania
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Vilnius, Lithuania
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Assen, Netherlands
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Beilen, Netherlands
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Bennebroek, Netherlands
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Enschede, Netherlands
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Groningen, Netherlands
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Hoofddorp, Netherlands
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Leeuwarden, Netherlands
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The Hague, Netherlands
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Tilburg, Netherlands
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Zwolle, Netherlands
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Bydgoszcz, Poland
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Gdynia Na, Poland
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Krakow Na, Poland
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Lubliniec, Poland
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Skorzewo Na, Poland
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Angra do Heroísmo, Portugal
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Braga, Portugal
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Castelo Viegas, Portugal
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Coimbra, Portugal
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Lisbon, Portugal
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Porto, Portugal
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Kazan', Russia
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Krasnodar, Russia
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Moscow, Russia
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Moscow Russia, Russia
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Saint Peterburg Na, Russia
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Saint Petersburg, Russia
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Saratov, Russia
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Yaroslavl, Russia
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Belgrade, Serbia
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Kragujevac, Serbia
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Novi Sad, Serbia
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Alicante, Spain
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Barcelona, Spain
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Bunyola Illes Balears, Spain
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Burgos, Spain
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Oviedo, Spain
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Pontevedra, Spain
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Sama de Langreo Asturias, Spain
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Valencia, Spain
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Zamora, Spain
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Zaragoza, Spain
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Bromma, Sweden
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Gothenburg, Sweden
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Hudiksvall, Sweden
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Karlskrona, Sweden
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Malmo, Sweden
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Mölndal, Sweden
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Norrtälje, Sweden
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Nyköping, Sweden
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Simrishamn, Sweden
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Skövde, Sweden
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Solna, Sweden
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Trollhättan, Sweden
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Västra Frölunda, Sweden
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Aarau, Switzerland
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Basel, Switzerland
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Basel Bs, Switzerland
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Biel/Bienne, Switzerland
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Geneva, Switzerland
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Lenzburg, Switzerland
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Liestal, Switzerland
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Marsens, Switzerland
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Montreux, Switzerland
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Münsingen, Switzerland
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Oetwil, Switzerland
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Riehen, Switzerland
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Sarnen, Switzerland
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Solothurn, Switzerland
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Viganello, Switzerland
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Zurich, Switzerland
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Ankara, Turkey (Türkiye)
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Denizli, Turkey (Türkiye)
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Diyarbakır, Turkey (Türkiye)
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Gaziantep, Turkey (Türkiye)
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Izmir, Turkey (Türkiye)
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Barnet, United Kingdom
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Birmingham, United Kingdom
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Clacton-on-Sea, United Kingdom
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Devon, United Kingdom
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Exeter, United Kingdom
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Glasgow, United Kingdom
Related Publications (1)
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.
PMID: 24491033RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 13, 2007
First Posted
April 16, 2007
Study Start
April 25, 2007
Primary Completion
January 22, 2009
Study Completion
March 4, 2020
Last Updated
April 27, 2025
Record last verified: 2025-04