Clinical trial NCT00460512: An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Flexible dosing
Non-acute patients
Antipsychotic
Atypical
INVEGA
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2007-04-16
Enrollment: 1814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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).

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

Primary outcomes:
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
timeFrame: Endpoint (up to Week 26)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
Secondary outcomes:
measure: Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
timeFrame: Endpoint (up to Week 26)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Number of Participants With Satisfaction With the Study Treatment
timeFrame: Endpoint (up to Week 26)
measure: Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
measure: Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
timeFrame: Baseline and endpoint (up to Week 26)
Other outcomes:
Locations:
city: Antwerpen
country: Belgium
city: Bertrix
country: Belgium
city: Dave
country: Belgium
city: Diest
country: Belgium
city: Duffel
country: Belgium
city: Kortenberg
country: Belgium
city: Liège
country: Belgium
city: Montignies-sur-Sambre
country: Belgium
city: Mortsel
country: Belgium
city: Roeselare
country: Belgium
city: Saint Denijs-Westrem
country: Belgium
city: Saint-Servais
country: Belgium
city: Sint-Truiden
country: Belgium
city: Tielt
country: Belgium
city: Waregem
country: Belgium
city: Bulgaria
country: Bulgaria
city: Sofia N/a
country: Bulgaria
city: Tzerova Korya
country: Bulgaria
city: Osijek
country: Croatia
city: Rijeka
country: Croatia
city: Split
country: Croatia
city: Zagreb
country: Croatia
city: Aalborg
country: Denmark
city: Helsingør
country: Denmark
city: Risskov N/a
country: Denmark
city: Viby J
country: Denmark
city: Helsinki
country: Finland
city: Raahe
country: Finland
city: Tammisaari
country: Finland
city: Tampere
country: Finland
city: Bar Le Duc
country: France
city: Bordeaux
country: France
city: Bourg En Bresse
country: France
city: Bully Les Mines
country: France
city: Caen
country: France
city: Chambery
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city: Clermont Ferrand Cedex 1
country: France
city: Creteil Cedex
country: France
city: Dijon Cedex
country: France
city: Dole
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city: Henin Baumont
country: France
city: Jarnac
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city: La Roche Sur Yon
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city: La Seyne Sur Mer
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city: Mont St Martin
country: France
city: Montpellier
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city: Nimes Cedex 9
country: France
city: Paris
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city: Pau
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city: Rennes
country: France
city: Roubaix
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city: Saint Avé
country: France
city: Saint-Cyr Au Mont D'or N/a
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city: St Germain En Laye
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city: Villejuif Cedex
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city: Aalen
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city: Bamberg
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city: Butzbach
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city: Düsseldorf
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city: Ellwangen
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city: Elmshorn
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city: Siegen
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city: Stralsund
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city: Straubing
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city: Ulm
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city: Viersen
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city: Wasserburg
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city: Wiesbaden
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city: Wiesloch
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city: Wilhelmshaven
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city: Wismar
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city: Athens
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city: Chios
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city: Herakleion
country: Greece
city: Larisa
country: Greece
city: Thessalonikis
country: Greece
city: Balassagyarmat N/a
country: Hungary
city: Budapest N/a
country: Hungary
city: Kecskemet
country: Hungary
city: Sopron
country: Hungary
city: Bat-Yam
country: Israel
city: Be'er Ya'acov
country: Israel
city: Jerusalem
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city: Pardesia
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city: Jelgava
country: Latvia
city: Liepaja
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city: Strenci
country: Latvia
city: Kaunas
country: Lithuania
city: Panevezys
country: Lithuania
city: Vilnius
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city: 's-Gravenhage
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city: Assen
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city: Beilen
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city: Bennebroek
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city: Groningen
country: Netherlands
city: Hoofddorp
country: Netherlands
city: Leeuwarden
country: Netherlands
city: Tilburg
country: Netherlands
city: Zwolle
country: Netherlands
city: Bydgoszcz N/a
country: Poland
city: Gdynia Na
country: Poland
city: Krakow Na
country: Poland
city: Lubliniec
country: Poland
city: Skorzewo Na
country: Poland
city: Angra Do Heroísmo
country: Portugal
city: Braga
country: Portugal
city: Castelo Viegas N/a
country: Portugal
city: Coimbra
country: Portugal
city: Lisboa N/a
country: Portugal
city: Lisboa
country: Portugal
city: Porto N/a
country: Portugal
city: Porto
country: Portugal
city: Kazan
country: Russian Federation
city: Krasnodar
country: Russian Federation
city: Moscow N/a
country: Russian Federation
city: Moscow Russia
country: Russian Federation
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Saratov
country: Russian Federation
city: St Peterburg Na
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: Yaroslavl
country: Russian Federation
city: Beograd
country: Serbia
city: Kragujevac
country: Serbia
city: Novi Sad
country: Serbia
city: Alicante
country: Spain
city: Barcelona
country: Spain
city: Bunyola Illes Balears
country: Spain
city: Burgos
country: Spain
city: Oviedo
country: Spain
city: Pontevedra
country: Spain
city: Sama De Langreo Asturias
country: Spain
city: Valencia
country: Spain
city: Zamora
country: Spain
city: Zaragoza
country: Spain
city: Bromma
country: Sweden
city: Göteborg
country: Sweden
city: Hudiksvall
country: Sweden
city: Karlskrona
country: Sweden
city: Malmö
country: Sweden
city: Mölndal
country: Sweden
city: Norrtälje
country: Sweden
city: Nyköping
country: Sweden
city: Simrishamn
country: Sweden
city: Skövde
country: Sweden
city: Solna
country: Sweden
city: Trollhättan
country: Sweden
city: Västra Frölunda
country: Sweden
city: Aarau
country: Switzerland
city: Basel Bs
country: Switzerland
city: Basel
country: Switzerland
city: Bienne
country: Switzerland
city: Geneve
country: Switzerland
city: Lenzburg
country: Switzerland
city: Liestal
country: Switzerland
city: Marsens
country: Switzerland
city: Montreux
country: Switzerland
city: Munsingen
country: Switzerland
city: Oetwil Am See
country: Switzerland
city: Riehen
country: Switzerland
city: Sarnen
country: Switzerland
city: Solothurn
country: Switzerland
city: Viganello
country: Switzerland
city: Zurich
country: Switzerland
city: Zürich
country: Switzerland
city: Ankara N/a
country: Turkey
city: Denizli
country: Turkey
city: Diyarbakir
country: Turkey
city: Gaziantep
country: Turkey
city: Izmir
country: Turkey
city: Barnet
country: United Kingdom
city: Birmingham
country: United Kingdom
city: Clacton On Sea
country: United Kingdom
city: Devon
country: United Kingdom
city: Exeter
country: United Kingdom
city: Glasgow
country: United Kingdom
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.