Back to resultsAn Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia (PERFlexS)
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Paliperidone ER
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Flexible dosing, Non-acute patients, Antipsychotic, Atypical, INVEGA
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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Paliperidone Extended Release (ER)
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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).
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.
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).
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.
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.
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).
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).
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.
Full Information
NCT ID
NCT00460512
First Posted
April 13, 2007
Last Updated
March 23, 2021
Sponsor
Janssen-Cilag International NV
1. Study Identification
Unique Protocol Identification Number
NCT00460512
Brief Title
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
Acronym
PERFlexS
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
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
April 25, 2007 (Actual)
Primary Completion Date
January 22, 2009 (Actual)
Study Completion Date
March 4, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen-Cilag International NV
4. Oversight
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Flexible dosing, Non-acute patients, Antipsychotic, Atypical, INVEGA
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1814 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone Extended Release (ER)
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Paliperidone ER
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Endpoint (up to Week 26)
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Endpoint (up to Week 26)
Description
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.
Time Frame
Baseline and endpoint (up to Week 26)
Secondary Outcome Measure Information:
Title
Percentage of Participants With at Least 20 Percent Improvement in Total Positive and Negative Syndrome Scale (PANSS) Score
Description
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.
Time Frame
Endpoint (up to Week 26)
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Subscale Scores at Endpoint (up to Week 26)
Description
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).
Time Frame
Baseline and endpoint (up to Week 26)
Title
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Marder Subscale Scores at Endpoint (up to Week 26)
Description
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.
Time Frame
Baseline and endpoint (up to Week 26)
Title
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Endpoint (up to Week 26)
Description
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).
Time Frame
Baseline and endpoint (up to Week 26)
Title
Change From Baseline in Total Personal and Social Performance (PSP) Score at Endpoint (up to Week 26)
Description
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.
Time Frame
Baseline and endpoint (up to Week 26)
Title
Change From Baseline in Short-Form 36 Health Survey (SF-36) Score at Endpoint (up to Week 26)
Description
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.
Time Frame
Baseline and endpoint (up to Week 26)
Title
Number of Participants With Satisfaction With the Study Treatment
Description
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).
Time Frame
Endpoint (up to Week 26)
Title
Change From Baseline in Sleep and Daytime Drowsiness Evaluation Score at Endpoint (up to Week 26)
Description
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).
Time Frame
Baseline and endpoint (up to Week 26)
Title
Change From Baseline in Extrapyramidal Symptoms Rating Scale (ESRS) Total Score at Endpoint (up to Week 26)
Description
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.
Time Frame
Baseline and endpoint (up to Week 26)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen-Cilag International NV Clinical Trial
Organizational Affiliation
Janssen-Cilag International NV
Official's Role
Study Director
Facility Information:
City
Antwerpen
Country
Belgium
City
Bertrix
Country
Belgium
City
Dave
Country
Belgium
City
Diest
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Belgium
City
Duffel
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Belgium
City
Kortenberg
Country
Belgium
City
Liège
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Belgium
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Montignies-sur-Sambre
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Belgium
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Mortsel
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Belgium
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Roeselare
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Belgium
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Saint Denijs-Westrem
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Belgium
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Saint-Servais
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Belgium
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Sint-Truiden
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Belgium
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Tielt
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Belgium
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Waregem
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Belgium
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Bulgaria
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Bulgaria
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Sofia N/a
Country
Bulgaria
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Tzerova Korya
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Bulgaria
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Osijek
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Croatia
City
Rijeka
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Croatia
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Split
Country
Croatia
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Zagreb
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Croatia
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Aalborg
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Denmark
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Helsingør
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Denmark
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Risskov N/a
Country
Denmark
City
Viby J
Country
Denmark
City
Helsinki
Country
Finland
City
Raahe
Country
Finland
City
Tammisaari
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Finland
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Tampere
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Finland
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Bar Le Duc
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France
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Bordeaux
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France
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Bourg En Bresse
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France
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Bully Les Mines
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France
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Caen
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France
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Chambery
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France
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Clermont Ferrand Cedex 1
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France
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Creteil Cedex
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France
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Dijon Cedex
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France
City
Dole
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France
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Henin Baumont
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France
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Jarnac
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France
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La Roche Sur Yon
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France
City
La Seyne Sur Mer
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France
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Mont St Martin
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France
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Montpellier
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France
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Nimes Cedex 9
Country
France
City
Paris
Country
France
City
Pau
Country
France
City
Rennes
Country
France
City
Roubaix
Country
France
City
Saint Avé
Country
France
City
Saint-Cyr Au Mont D'or N/a
Country
France
City
St Germain En Laye
Country
France
City
Villejuif Cedex
Country
France
City
Aalen
Country
Germany
City
Achim
Country
Germany
City
Augsburg
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Germany
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Bamberg
Country
Germany
City
Bergfelde
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Germany
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Bergheim
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Germany
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Berlin
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Germany
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Bochum
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Germany
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Butzbach
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Germany
City
Chemnitz
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Germany
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Coesfeld
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Germany
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Darmstadt
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Germany
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Dillingen
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Germany
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Dresden
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Germany
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Duisburg
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Germany
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Düsseldorf
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Germany
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Ebensfeld
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Germany
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Eberbach
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Germany
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Ellwangen
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Germany
City
Elmshorn
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Germany
City
Essen
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Germany
City
Ettlingen
Country
Germany
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Freiburg
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Germany
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Gelnhausen
Country
Germany
City
Gelsenkirchen
Country
Germany
City
Gießen
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Germany
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Göttingen
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Germany
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Haina
Country
Germany
City
Halle
Country
Germany
City
Hamburg
Country
Germany
City
Hannover
Country
Germany
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Hattingen
Country
Germany
City
Hemer
Country
Germany
City
Hemmoor
Country
Germany
City
Heppenheim
Country
Germany
City
Idar-oberstein
Country
Germany
City
Jena
Country
Germany
City
Kaufbeuren
Country
Germany
City
Krefeld
Country
Germany
City
Köln
Country
Germany
City
Königsbrück
Country
Germany
City
Leipzig
Country
Germany
City
Liebenburg
Country
Germany
City
Lüdenscheid
Country
Germany
City
Mainz
Country
Germany
City
Mannheim
Country
Germany
City
Mittweida
Country
Germany
City
München
Country
Germany
City
Münster
Country
Germany
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Naumburg
Country
Germany
City
Norden
Country
Germany
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Nürnberg
Country
Germany
City
Ober-Ramstadt
Country
Germany
City
Oldenburg
Country
Germany
City
Oranienburg
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Germany
City
Ostfildern
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Germany
City
Potsdam
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Germany
City
Rostock
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Germany
City
Saalfeld
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Germany
City
Salzgitter
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Germany
City
Schlüchtern
Country
Germany
City
Siegen
Country
Germany
City
Spremberg
Country
Germany
City
Stralsund
Country
Germany
City
Straubing
Country
Germany
City
Ulm
Country
Germany
City
Viersen
Country
Germany
City
Wasserburg
Country
Germany
City
Wiesbaden
Country
Germany
City
Wiesloch
Country
Germany
City
Wilhelmshaven
Country
Germany
City
Wismar
Country
Germany
City
Würzburg
Country
Germany
City
Athens
Country
Greece
City
Chios
Country
Greece
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
Country
Israel
City
Pardesia
Country
Israel
City
Daugavpils
Country
Latvia
City
Jelgava
Country
Latvia
City
Liepaja
Country
Latvia
City
Riga
Country
Latvia
City
Strenci
Country
Latvia
City
Kaunas
Country
Lithuania
City
Panevezys
Country
Lithuania
City
Vilnius
Country
Lithuania
City
's-Gravenhage
Country
Netherlands
City
Assen
Country
Netherlands
City
Beilen
Country
Netherlands
City
Bennebroek
Country
Netherlands
City
Enschede
Country
Netherlands
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
24491033
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.
Results Reference
result
Learn more about this trial
An Efficacy, Safety And Tolerability Study of Flexibly Dosed Paliperidone Extended Release (ER) in Participants With Schizophrenia
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