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Study of Paliperidone Palmitate 3 Month and 1 Month Formulations 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)
PP1M 50 mg eq.
PP1M 75 mg eq.
PP1M 100 mg eq.
PP1M 150 mg eq.
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 1 month formulation (PP1M), Paliperidone palmitate 3 month formulation (PP3M)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Patients with schizophrenia for more than 1 year and whose symptoms are worsening in the opinion of the investigator
  • A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 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

Active Comparator

Arm Label

Paliperidone palmitate 3-month (PP3M)

Paliperidone palmitate 1-month (PP1M)

Arm Description

A formulation of paliperidone palmitate with a 3-month injection interval

A formulation of paliperidone palmitate with a 1-month injection interval

Outcomes

Primary Outcome Measures

Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.

Secondary Outcome Measures

Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.
Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Change From Baseline in Marder Factor Subscale Score at Week 48
5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.

Full Information

First Posted
January 17, 2012
Last Updated
April 28, 2016
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT01515423
Brief Title
Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia
Official Title
A Randomized, Multicenter, Double-Blind, Non-inferiority Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Subjects With Schizophrenia
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
February 2015 (Actual)
Study Completion Date
March 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to demonstrate that a paliperidone palmitate 3 month formulation (PP3M) is as effective as the paliperidone palmitate 1 month formulation (PP1M) in the treatment of patients with schizophrenia who have been stabilized on PP1M.
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), multicenter non-inferiority (the effect of the new treatment is not worse than that of the comparison treatment) study. A new formulation of paliperidone palmitate with a 3-month injection interval (PP3M) is being tested for use as maintenance treatment for subjects with schizophrenia who have been first stabilized on paliperidone palmitate with a 1-month injection interval (PP1M). The study consists of 3 phases: a screening/washout/tolerability phase (up to 21 days); a 17-week open-label (all people know the identity of the intervention) stabilization phase (referred to as the Open-label Phase) and a 48-week fixed dose, randomized, double-blind controlled phase (referred to as the Double-blind Phase). After completion of the Screening Phase, all patients will receive PP1M in the Open-label Phase. During this time, flexible dosing will occur at Weeks 5 and 9. At Week 13 patients are to receive the dose of PP1M that was administered at Week 9. Patients who are clinically stable at the end of the Open-label Phase will enter the Double-blind Phase and will be randomly assigned in a 1:1 ratio to receive fixed doses of PP3M or PP1M.

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 1 month formulation (PP1M), 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
1429 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Paliperidone palmitate 3-month (PP3M)
Arm Type
Experimental
Arm Description
A formulation of paliperidone palmitate with a 3-month injection interval
Arm Title
Paliperidone palmitate 1-month (PP1M)
Arm Type
Active Comparator
Arm Description
A formulation of paliperidone palmitate with a 1-month injection interval
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 third month for 48 weeks.
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 third month for 48 weeks.
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 third month for 48 weeks.
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 third month for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
Placebo (20% Intralipid)
Intervention Description
Form= injection, route= intramuscular use. One injection monthly when not receiving active medication for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
PP1M 50 mg eq.
Intervention Description
Type= exact number, unit= mg eq., number= 50, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
PP1M 75 mg eq.
Intervention Description
Type= exact number, unit= mg eq., number= 75, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
PP1M 100 mg eq.
Intervention Description
Type= exact number, unit= mg eq., number= 100, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Intervention Type
Drug
Intervention Name(s)
PP1M 150 mg eq.
Intervention Description
Type= exact number, unit= mg eq., number= 150, form= injection, route= intramuscular use. One injection every month for 48 weeks.
Primary Outcome Measure Information:
Title
Percentage of Participants Without Relapse at Week 48 During the Double-Blind Phase
Description
Relapse defined as: Psychiatric hospitalization;participant had an increase of 25 percent in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was greater than (>) 40; had a 10 point increase in total PANSS score from randomization for 2 consecutive assessments separated by 3-7 days if score at randomization was less than or equal to (<=) 40; deliberate self-injury or exhibited violent behavior resulting in suicide, clinically significant injury;suicidal or homicidal ideation and aggressive behavior;For PANSS items-had a score of greater than or equal to (>=) 5 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was <=3 at randomization; had a score of >=6 after randomization for 2 consecutive assessments separated by 3-7 days on any of above items if maximum score for these above PANSS items was 4 at randomization.
Time Frame
Up to 48 weeks
Secondary Outcome Measure Information:
Title
Change From Double-Blind (DB) Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 48
Description
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time Frame
DB Baseline (Week 17) and 48 week or DB Endpoint
Title
Change From DB Baseline in Clinical Global Impression Severity (CGI-S) Scale Score at Week 48
Description
The Clinical Global Impression Severity (CGI-S) rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Time Frame
DB Baseline (Week 17) and 48 week or DB Endpoint
Title
Change From DB Baseline in Personal and Social Performance (PSP) Total Score at Week 48
Description
The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. Score ranges from 1 to 100. Participants with a score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Time Frame
DB Baseline (Week 17) and 48 week or DB Endpoint
Title
Percentage of Participants Who Met the Criteria for Symptomatic Remission Based on Andreasen Criteria
Description
Symptomatic remission criterion was defined as having a simultaneous score of mild or less on all selected PANSS items (P1, P2, P3, N1, N4, N6, G5, and G9). Symptomatic remission was defined for the last 6 months of the Double-blind Phase as meeting the remission criterion during the 6 months prior to the End of study visit during the Double-blind Phase, with one excursion allowed.
Time Frame
Weeks 41 to 65
Title
Change From Baseline in Positive and Negative Syndrome Subscales Score at Week 48
Description
The neuropsychiatric symptoms of schizophrenia were assessed by means of the 30-item Positive and Negative Syndrome Scale (PANSS). The PANSS provides a total score (sum of the scores of all 30 items) ranging from 30 to 210, higher scores indicate more severe neuropsychiatric symptoms of schizophrenia. Scores for 3 subscales, that is, for positive subscale (sum of the scores of all 7 items) and negative subscale (sum of the scores of all 7 items) ranges from 7 (absent) to 49 (extreme psychopathology), and for the general psychopathology subscale (sum of the scores of all 16 items) score ranges from 16 (absent) to 112 (extreme psychopathology).
Time Frame
DB Baseline (Week 17) and 48 week or DB Endpoint
Title
Change From Baseline in Marder Factor Subscale Score at Week 48
Description
5 PANSS Marder factor scores (positive symptoms [range:8 to 56], negative symptoms [range: 7 to 49], disorganized thoughts [range: 7 to 49], uncontrolled hostility/excitement [range: 4 to 28], and anxiety/depression [range: 4 to 28]) were examined to gain insight into the symptoms affected by treatment with the study drug. Negative change from baseline in subscales score for positive symptoms, negative symptoms, disorganized thoughts, uncontrolled hostility/excitement, and anxiety/depression indicates improvement in various symptoms of schizophrenia.
Time Frame
DB Baseline (Week 17) and 48 week or DB Endpoint

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 and whose symptoms are worsening in the opinion of the investigator A total score in the Positive and Negative Syndrome Scale (PANSS) between 70 and 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
Glendale
State/Province
California
Country
United States
City
Long Beach
State/Province
California
Country
United States
City
Oakland
State/Province
California
Country
United States
City
Oceanside
State/Province
California
Country
United States
City
Orange
State/Province
California
Country
United States
City
San Diego
State/Province
California
Country
United States
City
New Britain
State/Province
Connecticut
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United States
City
Bradenton
State/Province
Florida
Country
United States
City
Kissimmee
State/Province
Florida
Country
United States
City
Tampa
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Florida
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United States
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Wichita
State/Province
Kansas
Country
United States
City
East Lansing
State/Province
Michigan
Country
United States
City
St. Louis
State/Province
Missouri
Country
United States
City
Las Vegas
State/Province
Nevada
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United States
City
Jamaica
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New York
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United States
City
Durham
State/Province
North Carolina
Country
United States
City
Canton
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Ohio
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United States
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Oklahoma City
State/Province
Oklahoma
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United States
City
Philadelphia
State/Province
Pennsylvania
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United States
City
Charleston
State/Province
South Carolina
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United States
City
Memphis
State/Province
Tennessee
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United States
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Austin
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Texas
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United States
City
Bothell
State/Province
Washington
Country
United States
City
Buenos Aires
Country
Argentina
City
Cordoba
Country
Argentina
City
Córdoba
Country
Argentina
City
Rosario
Country
Argentina
City
Elizabeth Vale
Country
Australia
City
Frankston
Country
Australia
City
Innsbruck
Country
Austria
City
Assebroek
Country
Belgium
City
Bertrix
Country
Belgium
City
Brussel - Jette
Country
Belgium
City
Dave
Country
Belgium
City
Heusden
Country
Belgium
City
Marchienne-Au-Pont
Country
Belgium
City
Sint-Denijs-Westrem
Country
Belgium
City
Rio De Janeiro
Country
Brazil
City
Bourgas N/A
Country
Bulgaria
City
Kazanlak
Country
Bulgaria
City
Radnevo
Country
Bulgaria
City
Sofia
Country
Bulgaria
City
Calgary
State/Province
Alberta
Country
Canada
City
Halifax
State/Province
Ontario
Country
Canada
City
Montreal
State/Province
Quebec
Country
Canada
City
Burlington
Country
Canada
City
Baoding
Country
China
City
Beijing
Country
China
City
Changsha
Country
China
City
Guangdong
Country
China
City
Guangzhou
Country
China
City
Hangzhou
Country
China
City
Kunming
Country
China
City
Shanghai
Country
China
City
Tianjin
Country
China
City
Wuhan
Country
China
City
Xi'An
Country
China
City
Brno
Country
Czech Republic
City
Horovice
Country
Czech Republic
City
Liberec
Country
Czech Republic
City
Praha 10
Country
Czech Republic
City
Praha 9
Country
Czech Republic
City
Prerov
Country
Czech Republic
City
Clermont Ferrand
Country
France
City
Dole
Country
France
City
Montpellier
Country
France
City
Toulon
Country
France
City
Bochum
Country
Germany
City
Gelsenkirchen
Country
Germany
City
Hamburg
Country
Germany
City
Heidelberg
Country
Germany
City
München
Country
Germany
City
Arta
Country
Greece
City
Athens
Country
Greece
City
Katerini
Country
Greece
City
Balassagyarmat N/A
Country
Hungary
City
Budapest
Country
Hungary
City
Gyõr
Country
Hungary
City
Kalocsa
Country
Hungary
City
Sopron
Country
Hungary
City
Aizuwakamatsu
Country
Japan
City
Fujioka
Country
Japan
City
Fujisawa
Country
Japan
City
Hadano
Country
Japan
City
Himeji
Country
Japan
City
Hitachi
Country
Japan
City
Ichikawa
Country
Japan
City
Kanuma
Country
Japan
City
Kanzaki
Country
Japan
City
Kashihara
Country
Japan
City
Kashiwara
Country
Japan
City
Kasuya
Country
Japan
City
Kawasaki
Country
Japan
City
Kitagunma
Country
Japan
City
Kochi
Country
Japan
City
Kodaira
Country
Japan
City
Kumagaya
Country
Japan
City
Kumamoto
Country
Japan
City
Kure
Country
Japan
City
Matsusaka
Country
Japan
City
Mitaka
Country
Japan
City
Moriguchi
Country
Japan
City
Nagasaki
Country
Japan
City
Naha
Country
Japan
City
Nirasaki
Country
Japan
City
Ohta
Country
Japan
City
Okayama
Country
Japan
City
Okinawa
Country
Japan
City
Sakai
Country
Japan
City
Shibukawa
Country
Japan
City
Takatsuki
Country
Japan
City
Toki
Country
Japan
City
Tokushima
Country
Japan
City
Tokyo
Country
Japan
City
Toyoake
Country
Japan
City
Ueda
Country
Japan
City
Yatsushiro
Country
Japan
City
Yokkaichi
Country
Japan
City
Yokohama
Country
Japan
City
Busan
Country
Korea, Republic of
City
Gwangju-Si
Country
Korea, Republic of
City
Gyeonggi-Do
Country
Korea, Republic of
City
Seoul
Country
Korea, Republic of
City
Guadalajara
Country
Mexico
City
Monterrey
Country
Mexico
City
Tlalnepantla
Country
Mexico
City
Belchatow
Country
Poland
City
Bydgoszcz
Country
Poland
City
Chelmno
Country
Poland
City
Gdynia Na
Country
Poland
City
Lubin
Country
Poland
City
Lubliniec
Country
Poland
City
Piekary Slaskie
Country
Poland
City
Torun N/A
Country
Poland
City
Zabki
Country
Poland
City
Almada N/A
Country
Portugal
City
Angra Do Heroísmo
Country
Portugal
City
Coimbra
Country
Portugal
City
Lisboa
Country
Portugal
City
Porto
Country
Portugal
City
Brasov
Country
Romania
City
Cluj-Napoca
Country
Romania
City
Arkhangelsk
Country
Russian Federation
City
Ekaterinburg
Country
Russian Federation
City
Gatchina
Country
Russian Federation
City
Krasnodar N/A
Country
Russian Federation
City
Moscow N/A
Country
Russian Federation
City
Nizhniy Novgorod
Country
Russian Federation
City
Saratov
Country
Russian Federation
City
Smolensk Region N/A
Country
Russian Federation
City
Smolensk
Country
Russian Federation
City
St Petersburg
Country
Russian Federation
City
St-Peterburg
Country
Russian Federation
City
St-Petersburg
Country
Russian Federation
City
Tomsk Na
Country
Russian Federation
City
Yaroslavl
Country
Russian Federation
City
Bratislava
Country
Slovakia
City
Michalovce
Country
Slovakia
City
Rimavska Sobota
Country
Slovakia
City
Trencin
Country
Slovakia
City
Alicante
Country
Spain
City
Baracaldo
Country
Spain
City
Barcelona
Country
Spain
City
Coslada
Country
Spain
City
Elche
Country
Spain
City
Madrid
Country
Spain
City
Zamora
Country
Spain
City
Uppsala
Country
Sweden
City
Bali Township, Taipei County
Country
Taiwan
City
Kaohsiung
Country
Taiwan
City
Taoyuan
Country
Taiwan
City
Glevakha
Country
Ukraine
City
Kharkov
Country
Ukraine
City
Kiev
Country
Ukraine
City
Odessa
Country
Ukraine
City
Poltava
Country
Ukraine

12. IPD Sharing Statement

Citations:
PubMed Identifier
32184607
Citation
Gopal S, Gogate J, Pungor K, Kim E, Singh A, Mathews M. Improvement of Negative Symptoms in Schizophrenia with Paliperidone Palmitate 1-Month and 3-Month Long-Acting Injectables: Results from a Phase 3 Non-Inferiority Study. Neuropsychiatr Dis Treat. 2020 Mar 6;16:681-690. doi: 10.2147/NDT.S226296. 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
30962688
Citation
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PubMed Identifier
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Mathews M, Pei H, Savitz A, Nuamah I, Hough D, Alphs L, Gopal S. Paliperidone Palmitate 3-Monthly Versus 1-Monthly Injectable in Patients With Schizophrenia With or Without Prior Exposure to Oral Risperidone or Paliperidone: A Post Hoc, Subgroup Analysis. Clin Drug Investig. 2018 Aug;38(8):695-702. doi: 10.1007/s40261-018-0647-z.
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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.
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Samtani MN, Nandy P, Ravenstijn P, Remmerie B, Vermeulen A, Russu A, D'hoore P, Baum EZ, Savitz A, Gopal S, Hough D. Prospective dose selection and acceleration of paliperidone palmitate 3-month formulation development using a pharmacometric bridging strategy. Br J Clin Pharmacol. 2016 Nov;82(5):1364-1370. doi: 10.1111/bcp.13050. Epub 2016 Jul 24.
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Study of Paliperidone Palmitate 3 Month and 1 Month Formulations for the Treatment of Patients With Schizophrenia

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