Prevention of Relapse With Injectable Paliperidone Palmitate Versus Oral Antipsychotics
PROSIPAL
A 24-month, Prospective, Randomized, Active-Controlled, Open-Label, Rater-Blinded, Multicenter, International Study of the Prevention of Relapse Comparing Long-Acting Injectable Paliperidone Palmitate to Treatment as Usual With Oral Antipsychotic Monotherapy in Adults With Schizophrenia
3 other identifiers
interventional
769
24 countries
92
Brief Summary
The purpose of this study is to assess the efficacy (how well the drug works; primarily through the time to relapse) of long-acting injectable paliperidone palmitate compared to treatment as usual with orally administered antipsychotics in monotherapy over 24 months in the treatment of recently diagnosed (1-5 years since diagnosis) schizophrenia.
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 Feb 2010
Typical duration for phase_3 schizophrenia
92 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2010
CompletedFirst Submitted
Initial submission to the registry
March 4, 2010
CompletedFirst Posted
Study publicly available on registry
March 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedResults Posted
Study results publicly available
February 18, 2015
CompletedFebruary 18, 2015
February 1, 2015
3 years
March 4, 2010
November 17, 2014
February 17, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Time to First Relapse Event
Number of days from baseline (day 1 of core phase) to relapse as evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25 percent (%) from baseline in the Positive And Negative Syndrome Score (PANSS) total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.
from baseline (Day 1 of core phase) up to maximally 24 months.
Number of Participants With a Relapse Event
Number of participants with a relapse event with relapses evaluated according the Csernansky criteria. A patient was considered to have relapsed if they met one or more of the following criteria: (1) psychiatric hospitalization; (2) an increase in the level of psychiatric care and an increase of 25% from baseline in the PANSS total score (or an increase of 10 points if the baseline score was 40 or less); (3) deliberate self-injury; (4) suicidal or homicidal ideation that was clinically significant in the investigator's judgment; (5) violent behavior resulting in clinically significant injury to another person or property damage; (6) substantial clinical deterioration, defined as a change score of 6 ("much worse") or 7 ("very much worse") on the Clinical Global Impressions Scale (CGI-C); and/or (7) the required dose of the antipsychotic exceeds the maximum approved dose.
from baseline (Day 1 of core phase) up to maximally 24 months
Secondary Outcomes (13)
Percentage of Treatment Responders
from baseline (day 1 of core phase) up to maximally 24 months
Change From Baseline in PANSS Total Score
Baseline, day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24
Change From Baseline in PANSS Subscale Score
Baseline (day 1 of core phase), day 8, month 12, 24
Change From Baseline in PANSS Marder Factor Scores
Baseline (day 1 of core phase), day 8, month 12 and 24
Change From Baseline in Clinical Global Impression Severity (CGI-S) Score
Baseline (day 1 of core phase), day 8, month 1, 2, 3, 4, 6, 9, 12, 15, 18, 21, 24
- +8 more secondary outcomes
Study Arms (2)
Paliperidone Palmitate
EXPERIMENTALpaliperidone palmitate injection with 150 mg equivalent on Day 1 100 mg equivalent on Day 8 75 mg equivalent on Day 38 and flexible dosing with 25 50 75 100 or 150 mg equivalent once monthly thereafter
Oral Antipsychotics
ACTIVE COMPARATORoral antipsychotics daily treatment according to local label for maximally 24 months
Interventions
injection with 150 mg equivalent on Day 1, 100 mg equivalent on Day 8, 75 mg equivalent on Day 38 and flexible dosing with 25, 50, 75, 100 or 150 mg equivalent once monthly thereafter
daily treatment according to local label for maximally 24 months
Eligibility Criteria
You may qualify if:
- Have been meeting the diagnostic criteria for schizophrenia for 1 to 5 years before screening, and have a history of treatment with antipsychotics
- Have a history of two or more relapses requiring psychiatric hospitalization in the preceding 24 months, which may include the current acute episode
- Experiencing at screening an acute schizophrenic episode with a Positive And Negative Syndrome Scale (PANSS) total score at screening between 70 and 120, inclusive
- Be healthy on the basis of physical examination, medical history and vital signs performed at screening
- Woman must be postmenopausal (for at least 1 year) or surgically sterile or abstinent or be practicing an effective method of birth control, must agree to continue to use the same method of contraception throughout the study and must have a negative urine pregnancy test at screening
- be able to fill out questionnaires
- Men must agree to use a double barrier method of birth control and to not donate sperm during the study and for 3 months after receiving the last dose of study drug
You may not qualify if:
- Patients that have never been treated with antipsychotics before
- Treatment resistant patient and/or currently (i.within the last 3 months) treated with clozapine
- Substance dependence within 6 months prior to entry and current intravenous drug use or abuse
- allergies, hypersensitivity, or intolerance to risperidone or paliperidone or excipients
- treatment with a long-acting injectable antipsychotic within three injection cycles prior to screening
- newly started psychotherapy program within the two months preceding the treatment phase baseline
- evidence of clinically significant hepatic, renal, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic, psychiatric, or metabolic disturbances in the past 6 months (as determined by medical history, clinical laboratory or ECG results, or physical examination) that would increase the risk associated with taking study medication or would confound the interpretation of the study
- history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
- involuntarily hospitalized patient
- pregnant or breast-feeding females
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (94)
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Vienna, Austria
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Bertrix, Belgium
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Ghent, Belgium
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Liège, Belgium
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Ostend, Belgium
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Burgas, Bulgaria
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Plovdiv, Bulgaria
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Radnevo, Bulgaria
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Zagreb, Croatia
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Brno, Czechia
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Litoměřice, Czechia
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Olomouc, Czechia
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Prague, Czechia
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Přerov, Czechia
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Alexandria, Egypt
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Cairo, Egypt
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Talinn, Estonia
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Tartu, Estonia
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Colombes, France
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La Seyne-sur-Mer, France
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Limoges, France
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Metz, France
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Paris, France
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Saint-Avé, France
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Berlin, Germany
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Bochum, Germany
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Mannheim, Germany
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München, Germany
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Thessalonikis, Greece
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Budapest, Hungary
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Kalocsa, Hungary
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Nagykálló, Hungary
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Sopron, Hungary
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Bat Yam, Israel
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Beer Yaakov, Israel
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Hod HaSharon, Israel
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Ramat Gan, Israel
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Tirat Hacarmel, Israel
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Amman, Jordan
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Šiauliai, Lithuania
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Vilnius, Lithuania
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Chełmno, Poland
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Gdansk, Poland
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Torun, Poland
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Ząbki, Poland
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Arad, Romania
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Bucharest, Romania
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Jebel, Romania
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Oradea, Romania
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Sibiu, Romania
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Ekaterinburg Na, Russia
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Krasnodar, Russia
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Nizny Novgorod, Russia
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Saint Petersburg, Russia
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Samara, Russia
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Saratov, Russia
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Tomsk, Russia
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Yaroslavl, Russia
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Bratislava, Slovakia
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Michalovce, Slovakia
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Rimavská Sobota, Slovakia
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Cape Town, South Africa
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Pretoria, South Africa
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Goyang, South Korea
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Incheon, South Korea
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Kyounggi, South Korea
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Seoul, South Korea
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Barcelona, Spain
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Burgos, Spain
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Elche, Spain
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Madrid, Spain
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Sant Boi de Llobregat, Spain
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Zamora, Spain
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Taichung, Taiwan
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Taipei, Taiwan
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Taoyuan District, Taiwan
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Istanbul, Turkey (Türkiye)
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Manisa Turkey, Turkey (Türkiye)
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Zonguldak, Turkey (Türkiye)
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Dnipropetrovsk, Ukraine
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Donetsk, Ukraine
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Hlevakha, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
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Kiev, Ukraine
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Lviv, Ukraine
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Odesa, Ukraine
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Poltava, Ukraine
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Simferopol, Ukraine
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Uzhhorod, Ukraine
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Birmingham, United Kingdom
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Exeter, United Kingdom
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London, United Kingdom
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Warrington, United Kingdom
Related Publications (1)
Lopena OJ, Alphs LD, Sajatovic M, Turkoz I, Sun L, Johnston KL, Sliwa JK, Najarian DM, Starr HL. Earlier Use of Long-Acting Injectable Paliperidone Palmitate Versus Oral Antipsychotics in Patients With Schizophrenia: An Integrated Patient-Level Post Hoc Analysis. J Clin Psychiatry. 2023 Sep 25;84(6):23m14788. doi: 10.4088/JCP.23m14788.
PMID: 37756123DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- EMEA Medical Affairs Director Psychiatry
- Organization
- Janssen-Cilag Germany
Study Officials
- STUDY DIRECTOR
Janssen-Cilag International NV Clinical Trial
Janssen-Cilag International NV
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 4, 2010
First Posted
March 5, 2010
Study Start
February 1, 2010
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
February 18, 2015
Results First Posted
February 18, 2015
Record last verified: 2015-02