SchizophreniaPhase 3PERFlexSNCT00460512
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Janssen-Cilag International NV at 231 sites in 22 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone ER
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,814 participants
- Where
- 231 sitesin 22 countries
- Study dates
- 25 Apr 2007to 4 Mar 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
231 sites in 22 countries.
231 sites in 22 countries
Germany73 sites
Study site
Aalen
Study site
Achim
Study site
Augsburg
Study site
Bamberg
Study site
Bergfelde
Study site
Bergheim
Study site
Berlin
Study site
Bochum
Study site
Butzbach
Study site
Chemnitz
Study site
Coesfeld
Study site
Cologne
Study site
Darmstadt
Study site
Dillingen
Study site
Dresden
Study site
Duisburg
Study site
Düsseldorf
Study site
Ebensfeld
Study site
Eberbach
Study site
Ellwangen
Study site
Elmshorn
Study site
Essen
Study site
Ettlingen
Study site
Freiburg im Breisgau
Study site
Gelnhausen
Study site
Gelsenkirchen
Study site
Giessen
Study site
Göttingen
Study site
Haina
Study site
Halle
Study site
Hamburg
Study site
Hanover
Study site
Hattingen
Study site
Hemer
Study site
Hemmoor
Study site
Heppenheim an der Bergstrasse
Study site
Idar-Oberstein
Study site
Jena
Study site
Kaufbeuren
Study site
Königsbrück
Study site
Krefeld
Study site
Leipzig
Study site
Liebenburg
Study site
Lüdenscheid
Study site
Mainz
Study site
Mannheim
Study site
Mittweida
Study site
München
Study site
Münster
Study site
Naumburg
Study site
Norden
Study site
Nuremberg
Study site
Ober-Ramstadt
Study site
Oldenburg
Study site
Oranienburg
Study site
Ostfildern
Study site
Potsdam
Study site
Rostock
Study site
Saalfeld
Study site
Salzgitter
Study site
Schlüchtern
Study site
Siegen
Study site
Spremberg
Study site
Stralsund
Study site
Straubing
Study site
Ulm
Study site
Viersen
Study site
Wasserburg
Study site
Wiesbaden
Study site
Wiesloch
Study site
Wilhelmshaven
Study site
Wismar
Study site
Würzburg
France25 sites
Study site
Bar-le-Duc
Study site
Bordeaux
Study site
Bourg-en-Bresse
Study site
Bully-les-Mines
Study site
Caen
Study site
Chambéry
Study site
Clermont-Ferrand
Study site
Créteil
Study site
Dijon
Study site
Dole
Study site
Henin Baumont
Study site
Jarnac
Study site
La Roche-sur-Yon
Study site
La Seyne-sur-Mer
Study site
Mont-Saint-Martin
Study site
Montpellier
Study site
Nîmes
Study site
Paris
Study site
Pau
Study site
Rennes
Study site
Roubaix
Study site
Saint-Avé
Study site
Saint-Cyr-au-Mont-d'Or
Study site
Saint-Germain-en-Laye
Study site
Villejuif
Switzerland16 sites
Study site
Aarau
Study site
Basel
Study site
Basel Bs
Study site
Biel/Bienne
Study site
Geneva
Study site
Lenzburg
Study site
Liestal
Study site
Marsens
Study site
Montreux
Study site
Münsingen
Study site
Oetwil
Study site
Riehen
Study site
Sarnen
Study site
Solothurn
Study site
Viganello
Study site
Zurich
Belgium15 sites
Study site
Antwerp
Study site
Bertrix
Study site
Dave
Study site
Diest
Study site
Duffel
Study site
Kortenberg
Study site
Liège
Study site
Montignies-sur-Sambre
Study site
Mortsel
Study site
Roeselare
Study site
Saint Denijs-Westrem
Study site
Saint-Servais
Study site
Sint-Truiden
Study site
Tielt
Study site
Waregem
Sweden13 sites
Study site
Bromma
Study site
Gothenburg
Study site
Hudiksvall
Study site
Karlskrona
Study site
Malmö
Study site
Mölndal
Study site
Norrtälje
Study site
Nyköping
Study site
Simrishamn
Study site
Skövde
Study site
Solna
Study site
Trollhättan
Study site
Västra Frölunda
Netherlands10 sites
Study site
Assen
Study site
Beilen
Study site
Bennebroek
Study site
Enschede
Study site
Groningen
Study site
Hoofddorp
Study site
Leeuwarden
Study site
The Hague
Study site
Tilburg
Study site
Zwolle
Spain10 sites
Study site
Alicante
Study site
Barcelona
Study site
Bunyola Illes Balears
Study site
Burgos
Study site
Oviedo
Study site
Pontevedra
Study site
Sama de Langreo Asturias
Study site
Valencia
Study site
Zamora
Study site
Zaragoza
Russia8 sites
Study site
Kazan'
Study site
Krasnodar
Study site
Moscow
Study site
Moscow Russia
Study site
Saint Peterburg Na
Study site
Saint Petersburg
Study site
Saratov
Study site
Yaroslavl
Portugal6 sites
Study site
Angra do Heroísmo
Study site
Braga
Study site
Castelo Viegas
Study site
Coimbra
Study site
Lisbon
Study site
Porto
United Kingdom6 sites
Study site
Barnet
Study site
Birmingham
Study site
Clacton-on-Sea
Study site
Devon
Study site
Exeter
Study site
Glasgow
Greece5 sites
Study site
Athens
Study site
Chios
Study site
Heraklion
Study site
Larissa
Study site
Thessalonikis
Latvia5 sites
Study site
Daugavpils
Study site
Jelgava
Study site
Liepāja
Study site
Riga
Study site
Strenči
Poland5 sites
Study site
Bydgoszcz
Study site
Gdynia Na
Study site
Krakow Na
Study site
Lubliniec
Study site
Skorzewo Na
Turkey (Türkiye)5 sites
Study site
Ankara
Study site
Denizli
Study site
Diyarbakır
Study site
Gaziantep
Study site
Izmir
Croatia4 sites
Study site
Osijek
Study site
Rijeka
Study site
Split
Study site
Zagreb
Denmark4 sites
Study site
Aalborg
Study site
Elsinore
Study site
Risskov
Study site
Viby J
Finland4 sites
Study site
Ekenäs
Study site
Helsinki
Study site
Raahe
Study site
Tampere
Hungary4 sites
Study site
Balassagyarmat
Study site
Budapest
Study site
Kecskemét
Study site
Sopron
Israel4 sites
Study site
Bat Yam
Study site
Be'er Ya'acov
Study site
Jerusalem
Study site
Pardesiyya
About this study
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
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.
Read the 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
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Flexible dosing, Non-acute patients, Antipsychotic, Atypical, INVEGA
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone Extended Release (ER) | Experimental | Not described Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores 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). Positive subscale score ranges from 7 (absent) to 49 (extreme psychopathology), negative subscale score ranges from 7 (absent) to 49 (extreme psychopathology) and general psychopathology subscale score ranges from 16 (absent) to 112 (extreme psychopathology).
Measured: 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)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Marder PANSS subscales include positive symptoms subscale consisting of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consisting of 7 items with total score range of 7-49; and uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consisting of 4 items with total score range of 4-28. Higher score indicates greater severity.
Measured: Baseline and endpoint (up to Week 26)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
The CGI-S rating scale assesses the severity of a participant's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Measured: Baseline and endpoint (up to Week 26)
Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
The PSP scale assesses the degree of dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision.
Measured: Baseline and endpoint (up to Week 26)
Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26)
The SF-36 is a health status survey with 36 questions measuring 8 dimensions (physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional, and mental health) that are subsequently aggregated into 2 summary scales, Physical Component Summary (PCS) and Mental Component Summary (MCS). Each item is scored into on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
Measured: Baseline and endpoint (up to Week 26)
Number of Participants With Satisfaction With the Study Treatment
Participants will assess their satisfaction with paliperidone ER on a 5-point scale: 1 (very good), 2 (good), 3 (moderate), 4 (poor) and 5 (very poor).
Measured: Endpoint (up to Week 26)
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26)
The Sleep and Daytime Drowsiness Evaluation Scale is a self-administered scale that rates quality of sleep and daytime drowsiness. Participants indicate on an 11 point scale how well they have slept in the previous 7 days, score ranging from 0 (very badly) to 10 (very well) and how often they have felt drowsy within the previous 7 days, score ranging from 0 (not at all) to 10 (all the time).
Measured: Baseline and endpoint (up to Week 26)
Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
The ESRS scale assesses parkinsonism (slow movements), dystonia (abnormal muscle movement causing focal/generalized, sustained muscle contractions, postures, and involuntary movements) and dyskinetic (involuntary muscle contractions) movement subscale. Parkinsonism consists of 8 items rated on a 7-point scale (0=absent/normal and 6=worst score), Dystonia consists of 2 items rated on a 7-point scale (0=absent and 6=extremely severe) and Dyskinetic movements consists of 7 items rated on a 7-point scale (0=none and 6=worst score). Total score: 0-102. Lower scores indicate better condition.
Measured: Baseline and endpoint (up to Week 26)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2007 (estimated)
- Study start25 Apr 2007
- Primary completion22 Jan 2009
- Study completion4 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag International NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag International NV Clinical Trial, Study director, Janssen-Cilag International NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00460512
- Sponsor's protocol ID
- CR012949
- Other IDs
- R076477SCH3017, 2006-004265-34
- Acronym
- PERFlexS
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2007
- Last updated
- 27 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24491033
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT00460512
- Acronym / sponsor ID
- PERFlexS / CR012949
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Flexible dosing, Non-acute patients, Antipsychotic, Atypical, INVEGA
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,814 participants (actual)
- Lead sponsor
- Janssen-Cilag International NVIndustry (pharma, biotech, devices)
- Study start
- 25 Apr 2007 (actual)
- Primary completion
- 22 Jan 2009 (actual)
- Study completion
- 4 Mar 2020 (actual)
- First posted
- 16 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone Extended Release (ER) | Experimental | Drug: Paliperidone ER |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paliperidone ERPaliperidone 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. | Drug | Paliperidone Extended Release (ER) |
Primary outcome
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
Time frame: Endpoint (up to Week 26)
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.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
Time frame: Baseline and 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.
9 secondary outcomes
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
Time frame: Endpoint (up to Week 26)
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26)
Time frame: 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)
Time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
Time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
Time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26)
Time frame: Baseline and endpoint (up to Week 26)
Number of Participants With Satisfaction With the Study Treatment
Time frame: Endpoint (up to Week 26)
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26)
Time frame: Baseline and endpoint (up to Week 26)
Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
Time frame: Baseline and endpoint (up to Week 26)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2025.
- Results publication: PubMed 24491033Schreiner 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Janssen-Cilag International NV Clinical Trial study director
Janssen-Cilag International NV
231 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Janssen-Cilag International NV at 231 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 231 sites in Germany, France, Switzerland, Belgium, Sweden and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: Endpoint (up to Week 26)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00460512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2025.