A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
4 other identifiers
interventional
509
8 countries
53
Brief Summary
The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of 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 May 2012
53 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 6, 2012
CompletedFirst Posted
Study publicly available on registry
February 9, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedResults Posted
Study results publicly available
June 18, 2015
CompletedMay 11, 2016
May 1, 2016
1.9 years
February 6, 2012
April 7, 2015
May 2, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Time to Relapse During the Double-Blind Phase
Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.
Approximately Week 60
Secondary Outcomes (3)
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Study Arms (2)
Paliperidone palmitate 3-month (PP3M)
EXPERIMENTALPlacebo
PLACEBO COMPARATORInterventions
Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Eligibility Criteria
You may qualify if:
- Patients with schizophrenia for more than 1 year
- A total score in the Positive and Negative Syndrome Scale (PANSS) \< 120
- Signed informed consent
- Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
- Men must agree to use a double-barrier method of birth control
You may not qualify if:
- A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
- Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
- A diagnosis of substance dependence within 6 months before screening
- History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
- Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
- Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
- Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (53)
Unknown Facility
Little Rock, Arkansas, United States
Unknown Facility
San Fran Cisco, California, United States
Unknown Facility
Washington D.C., District of Columbia, United States
Unknown Facility
Lauderhill, Florida, United States
Unknown Facility
Chicago, Illinois, United States
Unknown Facility
Hoffman Estates, Illinois, United States
Unknown Facility
Topeka, Kansas, United States
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Baltimore, Maryland, United States
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Flowood, Mississippi, United States
Unknown Facility
Marlton, New Jersey, United States
Unknown Facility
Cedarhurst, New York, United States
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Oklahoma City, Oklahoma, United States
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Austin, Texas, United States
Unknown Facility
Dallas, Texas, United States
Unknown Facility
Salt Lake City, Utah, United States
Unknown Facility
Barranquilla, Colombia
Unknown Facility
Bogotá, Colombia
Unknown Facility
Medellín, Colombia
Unknown Facility
Pereira, Colombia
Unknown Facility
Johor Bahru, Malaysia
Unknown Facility
Kuala Lumpur, Malaysia
Unknown Facility
Tanjong Rambutan, Malaysia
Unknown Facility
Guadajalara, Mexico
Unknown Facility
Mexico City, Mexico
Unknown Facility
Monterrey, Mexico
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San Luis Potosí City, Mexico
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Zapopan, Mexico
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Arad, Romania
Unknown Facility
Craiova, Romania
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Iași, Romania
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Sibiu, Romania
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Tg Mures, Romania
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Deajun, South Korea
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Gyeongsangnam-Do, South Korea
Unknown Facility
Incheon, South Korea
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Seongnam, South Korea
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Diyarbakır, Turkey (Türkiye)
Unknown Facility
Sakarya, Turkey (Türkiye)
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Donetsk, Ukraine
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Evpatoriya, Ukraine
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Hlevakha, Ukraine
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Ivano-Frankivsk, Ukraine
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Kerch, Ukraine
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Kharkiv, Ukraine
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Kherson, Ukraine
Unknown Facility
Kiev, Ukraine
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Lviv, Ukraine
Unknown Facility
Odesa, Ukraine
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Poltava, Ukraine
Unknown Facility
Smila, Ukraine
Unknown Facility
Ternopil, Ukraine
Unknown Facility
Uzhhorod, Ukraine
Unknown Facility
Vinnitsa, Ukraine
Related Publications (6)
Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.
PMID: 32606705DERIVEDSavitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.
PMID: 30994855DERIVEDWeiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.
PMID: 28640988DERIVEDMagnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.
PMID: 27743205DERIVEDGopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.
PMID: 26306819DERIVEDBerwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241.
PMID: 25820612DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director Clinical Research
- Organization
- Janssen Research & Development, LLC
Study Officials
- STUDY DIRECTOR
Janssen Research & Development, LLC Clinical Trial
Janssen Research & Development, LLC
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 6, 2012
First Posted
February 9, 2012
Study Start
May 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 11, 2016
Results First Posted
June 18, 2015
Record last verified: 2016-05