Back to resultsA Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
PP3M 175 mg eq.
PP3M 263 mg eq.
PP3M 350 mg eq.
PP3M 525 mg eq.
Placebo (20% Intralipid emulsion)
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 3 month formulation (PP3M)
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Paliperidone palmitate 3-month (PP3M)
Placebo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
Full Information
NCT ID
NCT01529515
First Posted
February 6, 2012
Last Updated
May 2, 2016
Sponsor
Janssen Research & Development, LLC
1. Study Identification
Unique Protocol Identification Number
NCT01529515
Brief Title
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
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
April 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 3 month formulation (PP3M)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
509 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Paliperidone palmitate 3-month (PP3M)
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
PP3M 175 mg eq.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PP3M 263 mg eq.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PP3M 350 mg eq.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
PP3M 525 mg eq.
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo (20% Intralipid emulsion)
Intervention Description
Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.
Primary Outcome Measure Information:
Title
Time to Relapse During the Double-Blind Phase
Description
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.
Time Frame
Approximately Week 60
Secondary Outcome Measure Information:
Title
Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase
Description
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items). Each item is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.
Time Frame
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Title
Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase
Description
The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).
Time Frame
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
Title
Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase
Description
The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.
Time Frame
Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
City
Little Rock
State/Province
Arkansas
Country
United States
City
San Fran Cisco
State/Province
California
Country
United States
City
Washington
State/Province
District of Columbia
Country
United States
City
Lauderhill
State/Province
Florida
Country
United States
City
Chicago
State/Province
Illinois
Country
United States
City
Hoffman Estates
State/Province
Illinois
Country
United States
City
Topeka
State/Province
Kansas
Country
United States
City
Baltimore
State/Province
Maryland
Country
United States
City
Flowood
State/Province
Mississippi
Country
United States
City
Marlton
State/Province
New Jersey
Country
United States
City
Cedarhurst
State/Province
New York
Country
United States
City
Oklahoma City
State/Province
Oklahoma
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Dallas
State/Province
Texas
Country
United States
City
Salt Lake City
State/Province
Utah
Country
United States
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
12. IPD Sharing Statement
Citations:
PubMed Identifier
32606705
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.
Results Reference
derived
PubMed Identifier
30994855
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.
Results Reference
derived
PubMed Identifier
28640988
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.
Results Reference
derived
PubMed Identifier
27743205
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.
Results Reference
derived
PubMed Identifier
26306819
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.
Results Reference
derived
PubMed Identifier
25820612
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.
Results Reference
derived
Learn more about this trial
A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia
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