A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
NCT ID: NCT01529515
Last Updated: 2016-05-11
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
509 participants
INTERVENTIONAL
2012-05-31
2014-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Paliperidone palmitate 3-month (PP3M)
PP3M 175 mg eq.
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.
PP3M 263 mg eq.
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.
PP3M 350 mg eq.
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.
PP3M 525 mg eq.
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.
Placebo
Placebo (20% Intralipid emulsion)
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Interventions
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PP3M 175 mg eq.
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.
PP3M 263 mg eq.
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.
PP3M 350 mg eq.
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.
PP3M 525 mg eq.
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.
Placebo (20% Intralipid emulsion)
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Janssen Research & Development, LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Janssen Research & Development, LLC Clinical Trial
Role: STUDY_DIRECTOR
Janssen Research & Development, LLC
Locations
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Little Rock, Arkansas, United States
San Fran Cisco, California, United States
Washington D.C., District of Columbia, United States
Lauderhill, Florida, United States
Chicago, Illinois, United States
Hoffman Estates, Illinois, United States
Topeka, Kansas, United States
Baltimore, Maryland, United States
Flowood, Mississippi, United States
Marlton, New Jersey, United States
Cedarhurst, New York, United States
Oklahoma City, Oklahoma, United States
Austin, Texas, United States
Dallas, Texas, United States
Salt Lake City, Utah, United States
Barranquilla, , Colombia
Bogotá, , Colombia
Medellín, , Colombia
Pereira, , Colombia
Johor Bahru, , Malaysia
Kuala Lumpur, , Malaysia
Tanjong Rambutan, , Malaysia
Guadajalara, , Mexico
Mexico City, , Mexico
Monterrey, , Mexico
San Luis Potosí City, , Mexico
Zapopan, , Mexico
Arad, , Romania
Craiova, , Romania
Iași, , Romania
Sibiu, , Romania
Tg Mures, , Romania
Deajun, , South Korea
Gyeongsangnam-Do, , South Korea
Incheon, , South Korea
Seongnam, , South Korea
Diyarbakır, , Turkey (Türkiye)
Sakarya, , Turkey (Türkiye)
Donetsk, , Ukraine
Evpatoriya, , Ukraine
Hlevakha, , Ukraine
Ivano-Frankivsk, , Ukraine
Kerch, , Ukraine
Kharkiv, , Ukraine
Kherson, , Ukraine
Kiev, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
Poltava, , Ukraine
Smila, , Ukraine
Ternopil, , Ukraine
Uzhhorod, , Ukraine
Vinnitsa, , Ukraine
Countries
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References
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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.
Savitz 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.
Weiden 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.
Magnusson 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.
Gopal 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.
Berwaerts 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.
Other Identifiers
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R092670PSY3012
Identifier Type: OTHER
Identifier Source: secondary_id
2011-004676-11
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1135-1969
Identifier Type: OTHER
Identifier Source: secondary_id
CR100717
Identifier Type: -
Identifier Source: org_study_id
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