Clinical trial NCT01529515: A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
Official title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
R092670
Paliperidone Palmitate
Paliperidone palmitate 3 month formulation (PP3M)
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2012-02-09
Enrollment: 509
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Detailed description: This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Eligibility criteria: Inclusion Criteria:

* 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
* Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
* 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

Primary outcomes:
measure: Time to Relapse During the Double-Blind Phase
timeFrame: Approximately Week 60
Secondary outcomes:
measure: Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
timeFrame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
measure: Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
timeFrame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
measure: Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
timeFrame: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Other outcomes:
Locations:
city: Little Rock
country: United States
state: Arkansas
city: San Fran Cisco
country: United States
state: California
city: Washington
country: United States
state: District of Columbia
city: Lauderhill
country: United States
state: Florida
city: Chicago
country: United States
state: Illinois
city: Hoffman Estates
country: United States
state: Illinois
city: Topeka
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Flowood
country: United States
state: Mississippi
city: Marlton
country: United States
state: New Jersey
city: Cedarhurst
country: United States
state: New York
city: Oklahoma City
country: United States
state: Oklahoma
city: Austin
country: United States
state: Texas
city: Dallas
country: United States
state: Texas
city: Salt Lake City
country: United States
state: Utah
city: Barranquilla
country: Colombia
city: Bogota
country: Colombia
city: Medellin
country: Colombia
city: Pereira
country: Colombia
city: Deajun
country: Korea, Republic of
city: Gyeongsangnam-Do
country: Korea, Republic of
city: Incheon
country: Korea, Republic of
city: Seongnam
country: Korea, Republic of
city: Johor Bahru
country: Malaysia
city: Kuala Lumpur
country: Malaysia
city: Tanjong Rambutan
country: Malaysia
city: Guadajalara
country: Mexico
city: Mexico City
country: Mexico
city: Monterrey
country: Mexico
city: San Luis Potosi
country: Mexico
city: Zapopan
country: Mexico
city: Arad
country: Romania
city: Craiova
country: Romania
city: Iasi
country: Romania
city: Sibiu
country: Romania
city: Tg Mures
country: Romania
city: Diyarbakir
country: Turkey
city: Sakarya
country: Turkey
city: Donetsk
country: Ukraine
city: Evpatoriya
country: Ukraine
city: Glevakha
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Kerch
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kharkov
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Lviv
country: Ukraine
city: Lvov
country: Ukraine
city: Odesa
country: Ukraine
city: Odessa
country: Ukraine
city: Poltava
country: Ukraine
city: Smela
country: Ukraine
city: Ternopil
country: Ukraine
city: Uzhgorod
country: Ukraine
city: Vinnitsa
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.