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A Study of Paliperidone Palmitate 6-Month Formulation

Primary Purpose

Schizophrenia

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

PP6M

PP3M 350 mg eq.

PP3M 525 mg eq.

PP1M

Placebo

About this trial

This is an interventional treatment trial for Schizophrenia

Eligibility Criteria

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

Inclusion Criteria:

Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening
Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic
Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase
Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<) 70 points at screening
Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2 (inclusive) and must have a body weight of at least 47 kg at screening
Must be willing to receive gluteal injections of medication during the Double-blind Phase

Exclusion Criteria

Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment
Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening
Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator
Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia
Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe

Sites / Locations

Woodland Research Northwest
California Pharmaceutical Research Institute, Inc.
ATP Clinical Research
Collaborative NeuroScience Network
Synergy East
Pacific Research Partners
SF-Care, Inc
New Life Medical Research Center, Inc.
Clintex Research Group
Florida Research Center Inc.
Olympian Clinical Research
Atlanta Center for Medical Research
Uptown Research Institute
Alexian Behavioral Health Hospital
Ascension via Christi Research
Massachusetts General Hospital
Cherry Street Services, Inc.
St. Louis Clinical Trials
The Zucker Hillside Hospital
Clinical Trials of America Inc
Wexner Medical Center at the Ohio State University
Midwest Clinical Research Center
University of Pennsylvania Medical Center
Future Search Trials of Dallas
Psychiatric and Behavioral Solutions
Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales
CEN
Sanatorio Prof. Leon S. Morra
Instituto de Neurociencias San Agustín
Clinica Privada de Salud Mental Santa Teresa de Ávila
C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)
The Lyell McEwin Hospital
Neuro Trials Victoria
Trial Tech Tecnologia em Pesquisas com Medicamentos
Instituto Bairral de Psiquiatria
Hospital das Clinicas de Porto Alegre
Ruschel Medicina e Pesquisa Clínica Ltda
SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo
CPQuali Pesquisa Clinica LTDA ME
Hospital Das Clinicas Da Faculdade De Medicina Da USP
Mental Health Center Prof. Dr. Ivan Temkov
State Psychiatric Hospital Pazardzhik
UMHAT 'Sveti Georgi'-Plovdiv
State Psychiatric HospitalDr.Georgi Kissiov
Centre for Mental Health Prof.N.Shipkovenski EOOD
Medical Center Intermedica, OOD
Psychiatricka ambulance, MUDr. Marta Holanova
NeuropsychiatrieHK, s.r.o.
A-Shine s.r.o.
Institut Neuropsychiatricke pece
Psychiatricka ambulance MUDr. Simona Papezova
PRAGTIS s.r.o.
C.H.S. Charles Perrens
CHRU La Colombière
CHU Caremeau
Hopital Sainte Anne
Hôpital Sainte Musse
Kwai Chung Hospital
Queen Mary Hospital
Józsefvarosi Szent Kozma Egészségügyi Központ
Petz Aladar Megyei Oktato Korhaz
Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza
CRU Hungary Kft.
Ratandeep Multispeciality Hospital
Sri Ramachandra Medical Centre
Asha hospital
Ahana Hospitals
Vinaya Hospital and Research Center
Kasturba Medical College Hospital
Jehangir Clinical Development Center Pvt Ltd
Deva Institute of Health Care and Research Pvt Ltd
Clinica Psichiatrica - Università di Cagliari
Dipartimento di Salute Mentale
Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria
Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea
Chonnam National University Hospital
CHA Bundang Medical Center, CHA University
Chonbuk National Univ Hospital
Seoul National University Hospital
Hospital Bahagia Ulu Kinta
Hospital Kuala Lumpur
University Malaya Medical Centre
Sarawak General Hospital
Gabipros SC.
Instituto Neuropsique
Centro de Estudios Clinicos y Especialidades Medicas, S.C.
Infosame/Research
Centro de Atencion e Investigacion Cardiovascular del Potosi, S.C.
Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk
Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski
Zespol Opieki Zdrowotnej w Chelmnie
Centrum Badań Klinicznych PI-House sp. z o.o.
Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny
Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS
Centrum Medyczne Luxmed Sp z o o
Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim
Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie
Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu
Sverdlovsk Regional Clinical Psychiatric Hospital
Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky
Psychiatric Clinical hospital 1 named after N.A. Alekseev
Nizny Novgorod clinical psychiatric hospital 1
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov Regional Psychiatric hospital named after St. Sofia
Psychoneurological Dispensary of Frunzensky District
Psychoneurological dispensary 10
St-Petersburg Bekhterev Psychoneurological Research Institute
Psychoneurological dispensary 1
Psychoneurological Dispensary #4
Research Institute of Mental Health
Flexivest 14 Research
Gert Bosch - Pretoria South Africa
Juan Schrönen - Western Cape South Africa
Hosp. Univ. Vall D Hebron
Inst. Internac. Neurociencias Aplicadas
Hosp. Univ. de Basurto
Centro Salud Mental La Corredoria
Hosp. El Bierzo
Hosp. Clinico Univ. de Valencia
Hosp. Prov. de Zamora
National Cheng Kung University Hospital
Mackay Memorial Hospital
Taipei Veterans General Hospital
Chang Gung Memorial Hospital
Abdurrah Yurtarslan Training and Research Hospital
Ankara Numune Research and Training Hospital
Erenkoy Mental Health Hospital
Selcuk University, Medical School, Department of Psychiatry
Sakarya University Medical Faculty Psychiatry Department
MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association
Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'
CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council
Kyiv Territorial Medical Incorporation 'Psychiatry'
Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'
CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'
CNCE Odesa regional psychiatric hospital #2 Odesa regional council
CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'
CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

PP1M: Transition Phase

PP1M/PP3M: Maintenance Phase

PP6M or Placebo: Double-Blind Phase

PP3M: Double-Blind Phase

Arm Description

Participants who previously have not achieved stability with moderate to higher doses of Paliperidone palmitate 1-month (PP1M) or Paliperidone palmitate 3-month (PP3M) will enter into a transition period of up to 4 months. During transition period participants will receive 1 to 5 injections of PP1M 50 to 100 milligrams equivalent (mg eq.). The participants who achieved stability (stability is defined as at least 3 months of injections with the last 2 doses being the same strength) with PP1M 100 mg eq. will precede from transition phase to maintenance phase.

All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase.

Participants will receive intramuscular injection of PP6M in left gluteal muscle on Day 1 and right gluteal muscle on Day 183 with alternating placebo in right gluteal muscle on Day 92 and left gluteal muscle on Day 274.

Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183.

Outcomes

Primary Outcome Measures

Time to Relapse During the Double-Blind (DB) Phase

Time to relapse is time between participant randomization in DB Phase and first documentation of relapse event by end of Month 12 of DB phase. Relapse is defined as: a) Psychiatric hospitalization; b) Positive and Negative Syndrome Scale (PANSS) total score: Increase of 25 percentage (%), 10 point increase in PANSS for 2 analysis separated by 3-7 days if score was greater than (>) 40, less than or equal to (<=)40; c) Participants inflicted knowing self-injury/shown violent behavior leading to suicide, clinically significant injury to him/herself or other person/property; d) Participants had suicidal/homicidal ideation/violent behavior that was clinically significant as per investigator; e) PANSS items P1- delusions, P2- conceptual disorganization, P3-hallucinatory behavior, P6- suspiciousness/ persecution, P7-hostility, G8-uncooperativeness: score: greater than or equal to (>=)5, >=6 for 2 analysis separated by 3-7 days on any items if maximum score for PANSS: <=3 or 4, respectively.

Secondary Outcome Measures

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and scores for 3 subscales: the 7-item positive-symptom (P) subscale, the 7-item negative-symptom (N) subscale, and the 16-item general-psychopathology symptom (G) subscale. Each item is rated on a scale from 1 (absent) to 7 (extreme). The PANSS total score ranges from 30 (absent disease)-210 (more severe neuropsychiatric symptoms of schizophrenia).

Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score

CGI-S is defined as clinician-rated scale that assesses the severity of mental illness on a scale of 0 to 7. Considering total clinical experience, a participant was assessed on severity of mental illness at the time of rating according to:1: normal, not at all ill; 2: borderline mentally ill; 3: mildly ill; 4: moderately ill; 5: markedly ill; 6: severely ill; 7: among the most extremely ill patients. A higher score implies a more severe condition.

Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score

The Personal and Social Performance (PSP) scale assesses degree of a participant's dysfunction within 4 domains of behavior: 1) socially useful activities, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior. Each domain was assessed on a 6-point scale, from 1 (absent) to 6 (very severe) (1 = absent, 2 = mild, 3 = manifest, 4 = marked, 5 = severe, and 6 = very severe). PSP total score was calculated as sum of all the domain scores and ranges from 1 to 100. Participants with 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. Higher score indicates better performance.

Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase

Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity. The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity.

Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score

The SPSR Short Form 8a is a participant-reported outcome used to assess the satisfaction with participation in social roles. The participants were asked to rate 8 items on 5-point Likert scale, with scores ranging from 8 to 40, where higher scores represents higher satisfaction.

Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score

TSQM-9 consists of 9 questions to assess patients' satisfaction with medication using a range of responses from 1 (extremely dissatisfied) to (7 extremely satisfied). This patient reported outcome provides scores on three parts: effectiveness, convenience, and global satisfaction. The sum of the 9-questions were calculated and used for analysis. The total score ranges from 0 to 63, with higher scores indicating better treatment satisfaction.

Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score

The SAS rates 10 items for general extrapyramidal symptoms (EPS) on a 5-point scale from 0 (normal) to 4 (extreme), including gait, arm dropping, shoulder shaking, elbow rigidity, wrist rigidity, leg pendulousness, head rotation, Glabellar tap, tremor, and salivation. The SAS total score is the average score (total sum of item scores divided by the number of items) and ranges between 0 and 4. Negative change in score indicates improvement. Higher scores denote more severe condition of EPS.

Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score

BARS is used to rate observable, restless movements of drug induced akathisia and subjective awareness of restlessness and any distress associated with the akathisia. BARS consists of the following 4 items: objective assessment of akathisia symptoms, subjective assessment of the participants's awareness of inner restlessness, distress restlessness, and global clinical assessment of akathisia. First three items are rated on a 4-point scale ranging from 0 (no abnormal movements or absence of inner restlessness or no distress) to 3 (severe akathisia or awareness of intense compulsion to move most of the time or severe distress). The last item, the global clinical assessment of akathisia, is rated on a 6-point scale, ranging from 0 (no evidence of akathisia) to 5 (severe akathisia).

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score

AIMS is a 14-item scale. Items 1 to 8 are rated on a 5-point scale ranging from 0 (no dyskinetic movements) to 4 (severe dyskinetic movements). Item 9 assesses the participant's incapacitation due to abnormal movements, and item 10 assesses the participant's awareness of the abnormal movements and associated distress. Items 9 and 10 are rated on 5-point scales ranging from 0 (none or no awareness) to 4 (severe or aware, severe distress). Items 11 to 14 are yes/no questions regarding the global judgement and dental status of the participant. The total score is the sum of the scores for the 14 items and the possible total score ranges from 0 to 44. A higher total score is indicative of more severe dyskinetic movements.

Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score

The C-SSRS is a questionnaire used for suicide risk assessment. Affirmative or negative responses are provided to items 1 to 5 for suicidal ideation (1. Wish to be dead, 2. Non-specific active suicidal thoughts, 3. Active suicidal ideation with any methods [not plan] without intent to act, 4. Active suicidal ideation with some intent to act, without specific plan, 5. Active suicidal ideation with specific plan and intent) and items 6 to 10 for suicide behavior (6. Preparatory acts or behavior, 7. Aborted attempt, 8. Interrupted attempt, 9. Actual attempt, 10. Completed suicide). Total score ranges from 1 to 10. Higher scores indicate more severe suicidal ideation.

Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase

Number of participants with treatment-emergent abnormal ECG values were reported. It includes heart rate (abnormally low refers to less than or equal to [<=] 50 beats per minute (bpm) , abnormally high refers greater than or equal to [>=] 100 bpm), pulse rate (PR) interval (abnormally high refers to >= 210 milliseconds [msec]), QRS interval (abnormally Low refers to <= 50, abnormally high refers to >= 120 msec) and QT interval (abnormally low refers to <= 200, abnormally high >= 500 msec).

Change From Baseline in the Body Mass Index (BMI) During DB Phase

Change from baseline in BMI was reported.

Change From Baseline in the Waist Circumference During DB Phase

Change from baseline in waist circumference was reported.

Change From Baseline in the Body Weight During DB Phase

Change from baseline in body weight was reported.

Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase

Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate.

Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase

Change from baseline in vital signs including SBP and DBP (supine/standing) were reported.

Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase

The neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale, which provides a total score (sum of the scores for all 30 items) and 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).

Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase

Number of participants with clinically significant abnormal laboratory values in chemistry included alanine aminotransferase (Unit per Litre [U/L]), albumin (Gram per Litre [g/L]), alkaline phosphatase (U/L), aspartate aminotransferase (U/L), bicarbonate (millimoles per litre [mmol/L]), bilirubin (micromoles per litre [umol/L]), calcium (mmol/L), chloride (mmol/L), cholesterol (mmol/L), creatinine (umol/L), gamma glutamyl transferase (GGT) (U/L), glucose (mmol/L), high-density lipoproteins (HDL) cholesterol (mmol/L), low density lipoproteins (LDL) cholesterol (mmol/L), lactate dehydrogenase (U/L), phosphate (mmol/L), potassium (mmol/L), protein (mmol/L), sodium (mmol/L), triglycerides (mmol/L), urate (umol/L), urea nitrogen (mmol/L) were reported. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.

Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase

Number of participants with clinically significant abnormal laboratory values in hematology included hemoglobin (Hb), hematocrit (Hct), red blood cell (RBC) count, white blood cell (WBC) count with differential, platelets, hemoglobin A1c. Here, ABL signifies abnormally low and ABH signifies abnormally high levels.

Full Information

NCT ID

NCT03345342

First Posted

November 14, 2017

Last Updated

September 13, 2023

Sponsor

Janssen Research & Development, LLC

1. Study Identification

Unique Protocol Identification Number

NCT03345342

Brief Title

A Study of Paliperidone Palmitate 6-Month Formulation

Official Title

A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation

Study Type

Interventional

2. Study Status

Record Verification Date

September 2023

Overall Recruitment Status

Completed

Study Start Date

November 20, 2017 (Actual)

Primary Completion Date

May 8, 2020 (Actual)

Study Completion Date

May 8, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

The purpose of this study is to demonstrate that injection cycles consisting of a single administration of paliperidone palmitate 6-month (PP6M) are not less effective than 2 sequentially administered injections of paliperidone palmitate 3-month PP3M) (350 or 525 mg eq.) for the prevention of relapse in participants with schizophrenia previously stabilized on corresponding doses of paliperidone palmitate 1-month (PP1M) (100 or 150 mg eq.) or PP3M (350 or 525 mg eq.).

Detailed Description

The primary hypothesis of this study is that the efficacy of PP6M is non-inferior to PP3M for preventing relapse in participants with schizophrenia who were previously stabilized on corresponding doses of PP1M or PP3M. The study consists of mainly 3 phases: a screening phase (up to 28 days), a maintenance phase (of 1 or 3 months), and a double-blind phase (of 12 months [neither the researchers nor the participants know what treatment the participant is receiving]). Additional/conditional phases include a transition phase (before maintenance phase). Study evaluations include efficacy, pharmacokinetics, pharmacodynamics, and safety. The study duration will vary from approximately 13 months to 19 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

841 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PP1M: Transition Phase

Arm Type

Experimental

Arm Description

Arm Title

PP1M/PP3M: Maintenance Phase

Arm Type

Experimental

Arm Description

All the participants will receive only 1 dose of PP1M 100 or 150 mg eq. or PP3M 350 or 525 mg eq. The participants will precede from maintenance phase to double-blind phase.

Arm Title

PP6M or Placebo: Double-Blind Phase

Arm Type

Experimental

Arm Description

Arm Title

PP3M: Double-Blind Phase

Arm Type

Experimental

Arm Description

Participants will receive intramuscular injections of PP3M at dose of 350 mg eq. or 525 mg eq. in left gluteal muscle on Day 1 and 274 and right gluteal muscle on Day 92 and 183.

Intervention Type

Drug

Intervention Name(s)

PP6M

Other Intervention Name(s)

R092670

Intervention Description

Participants will receive intramuscular injection of PP6M.

Intervention Type

Drug

Intervention Name(s)

PP3M 350 mg eq.

Other Intervention Name(s)

R092670

Intervention Description

Participants will receive intramuscular injection of PP3M 350 mg eq.

Intervention Type

Drug

Intervention Name(s)

PP3M 525 mg eq.

Other Intervention Name(s)

R092670

Intervention Description

Participants will receive intramuscular injection of PP3M 525 mg eq.

Intervention Type

Drug

Intervention Name(s)

PP1M

Other Intervention Name(s)

R092670

Intervention Description

Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.

Intervention Type

Other

Intervention Name(s)

Placebo

Intervention Description

Participants will receive matching placebo.

Primary Outcome Measure Information:

Title

Time to Relapse During the Double-Blind (DB) Phase

Description

Time Frame

Up to 12 months of DB Phase

Secondary Outcome Measure Information:

Title

Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase

Description

Time Frame

Up to 12 months of DB Phase

Title

Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score

Description

Time Frame

Up to 12 Months of DB Phase

Title

Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score

Description

Time Frame

Baseline and endpoint (12 Months of DB Phase)

Title

Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Body Mass Index (BMI) During DB Phase

Description

Change from baseline in BMI was reported.

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Waist Circumference During DB Phase

Description

Change from baseline in waist circumference was reported.

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Body Weight During DB Phase

Description

Change from baseline in body weight was reported.

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase

Description

Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate.

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase

Description

Change from baseline in vital signs including SBP and DBP (supine/standing) were reported.

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase

Description

Time Frame

Baseline (DB) to 12 Months of DB Phase

Title

Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase

Description

Time Frame

Up to 12 Months of DB Phase

Title

Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase

Description

Time Frame

Up to 12 Months of DB Phase

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Must meet the diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM 5) for at least 6 months before screening Must be receiving treatment with paliperidone palmitate (as either the paliperidone palmitate 1-month (PP1M) or paliperidone palmitate 3-month (PP3M) formulation), or injectable risperidone, or any oral antipsychotic Must be able, in the opinion of the investigator, to discontinue any antipsychotic medication other than PP1M) or PP3M during the Screening Phase Must have a full Positive and Negative Syndrome Scale (PANSS) score of less than (<) 70 points at screening Must have a body mass index (BMI) between 17 and 40 kilogram (kg)/meter (m)^2 (inclusive) and must have a body weight of at least 47 kg at screening Must be willing to receive gluteal injections of medication during the Double-blind Phase Exclusion Criteria Must not be receiving any form of involuntary treatment, such as involuntary psychiatric hospitalization, parole-mandated treatment, or court-mandated treatment Must not have attempted suicide within 12 months before screening and must not be at imminent risk of suicide or violent behavior, as clinically assessed by the investigator at the time of screening Must not have a DSM-5 diagnosis of moderate or severe substance use disorder (except for nicotine and caffeine) within 6 months of screening; however, acute or intermittent substance use prior to screening is not exclusionary, depending upon the clinical judgment of the investigator Must not have a history of neuroleptic malignant syndrome or tardive dyskinesia Must not have a history of intolerability or severe reactions to moderate or higher doses of antipsychotic medications and must not have any other factors that would, in the judgment of the investigator, indicate that treatment with moderate or higher doses of paliperidone palmitate would be intolerable or unsafe

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:

Facility Name

Woodland Research Northwest

City

Rogers

State/Province

Arkansas

ZIP/Postal Code

72758

Country

United States

Facility Name

California Pharmaceutical Research Institute, Inc.

City

Anaheim

State/Province

California

ZIP/Postal Code

92804

Country

United States

Facility Name

ATP Clinical Research

City

Costa Mesa

State/Province

California

ZIP/Postal Code

92626

Country

United States

Facility Name

Collaborative NeuroScience Network

City

Garden Grove

State/Province

California

ZIP/Postal Code

92845

Country

United States

Facility Name

Synergy East

City

Lemon Grove

State/Province

California

ZIP/Postal Code

91945

Country

United States

Facility Name

Pacific Research Partners

City

Oakland

State/Province

California

ZIP/Postal Code

94607

Country

United States

Facility Name

SF-Care, Inc

City

San Rafael

State/Province

California

ZIP/Postal Code

94901

Country

United States

Facility Name

New Life Medical Research Center, Inc.

City

Hialeah

State/Province

Florida

ZIP/Postal Code

33012

Country

United States

Facility Name

Clintex Research Group

City

Miami

State/Province

Florida

ZIP/Postal Code

33135

Country

United States

Facility Name

Florida Research Center Inc.

City

Miami

State/Province

Florida

ZIP/Postal Code

33174

Country

United States

Facility Name

Olympian Clinical Research

City

Tampa

State/Province

Florida

ZIP/Postal Code

33614

Country

United States

Facility Name

Atlanta Center for Medical Research

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30331

Country

United States

Facility Name

Uptown Research Institute

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60640

Country

United States

Facility Name

Alexian Behavioral Health Hospital

City

Hoffman Estates

State/Province

Illinois

ZIP/Postal Code

60169

Country

United States

Facility Name

Ascension via Christi Research

City

Wichita

State/Province

Kansas

ZIP/Postal Code

67214

Country

United States

Facility Name

Massachusetts General Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02114

Country

United States

Facility Name

Cherry Street Services, Inc.

City

Grand Rapids

State/Province

Michigan

ZIP/Postal Code

49503

Country

United States

Facility Name

St. Louis Clinical Trials

City

Saint Louis

State/Province

Missouri

ZIP/Postal Code

63141

Country

United States

Facility Name

The Zucker Hillside Hospital

City

Glen Oaks

State/Province

New York

ZIP/Postal Code

11004

Country

United States

Facility Name

Clinical Trials of America Inc

City

Hickory

State/Province

North Carolina

ZIP/Postal Code

28601

Country

United States

Facility Name

Wexner Medical Center at the Ohio State University

City

Columbus

State/Province

Ohio

ZIP/Postal Code

43210

Country

United States

Facility Name

Midwest Clinical Research Center

City

Dayton

State/Province

Ohio

ZIP/Postal Code

45417

Country

United States

Facility Name

University of Pennsylvania Medical Center

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19104

Country

United States

Facility Name

Future Search Trials of Dallas

City

Dallas

State/Province

Texas

ZIP/Postal Code

75231

Country

United States

Facility Name

Psychiatric and Behavioral Solutions

City

Salt Lake City

State/Province

Utah

ZIP/Postal Code

84105-2425

Country

United States

Facility Name

Fundacion para el Estudio y Tratamiento de las Enfermedades Mentales

City

Ciudad Autónoma De Buenos Aires

ZIP/Postal Code

C1133AAH

Country

Argentina

Facility Name

CEN

City

Cordoba

ZIP/Postal Code

X5004FJF

Country

Argentina

Facility Name

Sanatorio Prof. Leon S. Morra

City

Cordoba

ZIP/Postal Code

X5009BIN

Country

Argentina

Facility Name

Instituto de Neurociencias San Agustín

City

La Plata

ZIP/Postal Code

1900

Country

Argentina

Facility Name

Clinica Privada de Salud Mental Santa Teresa de Ávila

City

La Plata

ZIP/Postal Code

B1904ADM

Country

Argentina

Facility Name

C.I.A.P. (Centro de investigación y Asistencia en Psiquiatría)

City

Rosario

ZIP/Postal Code

2000

Country

Argentina

Facility Name

The Lyell McEwin Hospital

City

Elizabeth Vale

ZIP/Postal Code

5112

Country

Australia

Facility Name

Neuro Trials Victoria

City

Noble Park

ZIP/Postal Code

3174

Country

Australia

Facility Name

Trial Tech Tecnologia em Pesquisas com Medicamentos

City

Curitiba

ZIP/Postal Code

80240-280

Country

Brazil

Facility Name

Instituto Bairral de Psiquiatria

City

Itapira

ZIP/Postal Code

13970-905

Country

Brazil

Facility Name

Hospital das Clinicas de Porto Alegre

City

Porto Alegre

ZIP/Postal Code

90035-903

Country

Brazil

Facility Name

Ruschel Medicina e Pesquisa Clínica Ltda

City

Rio de Janeiro

ZIP/Postal Code

22270-060

Country

Brazil

Facility Name

SPDM - Associacao Paulista para o Desenvolvimento da Medicina - Hospital Sao Paulo

City

Sao Paulo

ZIP/Postal Code

04020-060

Country

Brazil

Facility Name

CPQuali Pesquisa Clinica LTDA ME

City

São Paulo

ZIP/Postal Code

01228-900

Country

Brazil

Facility Name

Hospital Das Clinicas Da Faculdade De Medicina Da USP

City

São Paulo

ZIP/Postal Code

05403-903

Country

Brazil

Facility Name

Mental Health Center Prof. Dr. Ivan Temkov

City

Bourgas

ZIP/Postal Code

8001

Country

Bulgaria

Facility Name

State Psychiatric Hospital Pazardzhik

City

Pazardzhik

ZIP/Postal Code

4400

Country

Bulgaria

Facility Name

UMHAT 'Sveti Georgi'-Plovdiv

City

Plovdiv

ZIP/Postal Code

4002

Country

Bulgaria

Facility Name

State Psychiatric HospitalDr.Georgi Kissiov

City

Radnevo

ZIP/Postal Code

6260

Country

Bulgaria

Facility Name

Centre for Mental Health Prof.N.Shipkovenski EOOD

City

Sofia

ZIP/Postal Code

1377

Country

Bulgaria

Facility Name

Medical Center Intermedica, OOD

City

Sofia

ZIP/Postal Code

1680

Country

Bulgaria

Facility Name

Psychiatricka ambulance, MUDr. Marta Holanova

City

Brno

ZIP/Postal Code

61500

Country

Czechia

Facility Name

NeuropsychiatrieHK, s.r.o.

City

Hradec Kralove-Vekose

ZIP/Postal Code

50341

Country

Czechia

Facility Name

A-Shine s.r.o.

City

Plzen

ZIP/Postal Code

31200

Country

Czechia

Facility Name

Institut Neuropsychiatricke pece

City

Prague

ZIP/Postal Code

18600

Country

Czechia

Facility Name

Psychiatricka ambulance MUDr. Simona Papezova

City

Prague

ZIP/Postal Code

19000

Country

Czechia

Facility Name

PRAGTIS s.r.o.

City

Praha 2

ZIP/Postal Code

12000

Country

Czechia

Facility Name

C.H.S. Charles Perrens

City

Bordeaux

ZIP/Postal Code

33076

Country

France

Facility Name

CHRU La Colombière

City

Montpellier

ZIP/Postal Code

34090

Country

France

Facility Name

CHU Caremeau

City

Nimes Cedex 9

ZIP/Postal Code

30029

Country

France

Facility Name

Hopital Sainte Anne

City

Paris

ZIP/Postal Code

75674

Country

France

Facility Name

Hôpital Sainte Musse

City

Toulon Cedex

ZIP/Postal Code

83000

Country

France

Facility Name

Kwai Chung Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Queen Mary Hospital

City

Hong Kong

Country

Hong Kong

Facility Name

Józsefvarosi Szent Kozma Egészségügyi Központ

City

Budapest

ZIP/Postal Code

1084

Country

Hungary

Facility Name

Petz Aladar Megyei Oktato Korhaz

City

Gyor

ZIP/Postal Code

9023

Country

Hungary

Facility Name

Bács-Kiskun Megyei Kórház a Szegedi Tudományegyetem Általános Orvostudományi Kar Oktató Kórháza

City

Kalocsa

ZIP/Postal Code

6300

Country

Hungary

Facility Name

CRU Hungary Kft.

City

Miskolc

ZIP/Postal Code

3529

Country

Hungary

Facility Name

Ratandeep Multispeciality Hospital

City

Ahmedabad

ZIP/Postal Code

380008

Country

India

Facility Name

Sri Ramachandra Medical Centre

City

Chennai

ZIP/Postal Code

600116

Country

India

Facility Name

Asha hospital

City

Hyderabad

ZIP/Postal Code

500034

Country

India

Facility Name

Ahana Hospitals

City

Madurai

ZIP/Postal Code

625020

Country

India

Facility Name

Vinaya Hospital and Research Center

City

Mangalore

ZIP/Postal Code

575003

Country

India

Facility Name

Kasturba Medical College Hospital

City

Manipal

ZIP/Postal Code

576104

Country

India

Facility Name

Jehangir Clinical Development Center Pvt Ltd

City

Pune

ZIP/Postal Code

411001

Country

India

Facility Name

Deva Institute of Health Care and Research Pvt Ltd

City

Varanasi

ZIP/Postal Code

221005

Country

India

Facility Name

Clinica Psichiatrica - Università di Cagliari

City

Cagliari

ZIP/Postal Code

09127

Country

Italy

Facility Name

Dipartimento di Salute Mentale

City

Lecce

ZIP/Postal Code

73100

Country

Italy

Facility Name

Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

City

Napoli

ZIP/Postal Code

80138

Country

Italy

Facility Name

Universita degli Studi di Roma 'La Sapienza' - Azienda Ospedaliera Sant Andrea

City

Roma

ZIP/Postal Code

00189

Country

Italy

Facility Name

Chonnam National University Hospital

City

Gwangju

ZIP/Postal Code

61469

Country

Korea, Republic of

Facility Name

CHA Bundang Medical Center, CHA University

City

Gyeonggi-do

ZIP/Postal Code

13496

Country

Korea, Republic of

Facility Name

Chonbuk National Univ Hospital

City

Jeonju

ZIP/Postal Code

54907

Country

Korea, Republic of

Facility Name

Seoul National University Hospital

City

Seoul

ZIP/Postal Code

03080

Country

Korea, Republic of

Facility Name

Hospital Bahagia Ulu Kinta

City

Ipoh

ZIP/Postal Code

31250

Country

Malaysia

Facility Name

Hospital Kuala Lumpur

City

Kuala Lumpur

ZIP/Postal Code

50586

Country

Malaysia

Facility Name

University Malaya Medical Centre

City

Kuala Lumpur

ZIP/Postal Code

59100

Country

Malaysia

Facility Name

Sarawak General Hospital

City

Kuching

ZIP/Postal Code

93586

Country

Malaysia

Facility Name

Gabipros SC.

City

Mexico City

ZIP/Postal Code

07810

Country

Mexico

Facility Name

Instituto Neuropsique

City

Monterrey

ZIP/Postal Code

64610

Country

Mexico

Facility Name

Centro de Estudios Clinicos y Especialidades Medicas, S.C.

City

Monterrey

ZIP/Postal Code

64620

Country

Mexico

Facility Name

Infosame/Research

City

Monterrey

ZIP/Postal Code

64710

Country

Mexico

Facility Name

Centro de Atencion e Investigacion Cardiovascular del Potosi, S.C.

City

San Luis Potosí

ZIP/Postal Code

78200

Country

Mexico

Facility Name

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

City

Bialystok

ZIP/Postal Code

15-404

Country

Poland

Facility Name

Wlokiennicza MED Specjalistyczna Praktyka Lekarska dr n.med. Tomasz Markowski

City

Bialystok

ZIP/Postal Code

15-464

Country

Poland

Facility Name

Zespol Opieki Zdrowotnej w Chelmnie

City

Chelmno

ZIP/Postal Code

86-200

Country

Poland

Facility Name

Centrum Badań Klinicznych PI-House sp. z o.o.

City

Gdansk

ZIP/Postal Code

80-546

Country

Poland

Facility Name

Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

City

Gorlice

ZIP/Postal Code

38-300

Country

Poland

Facility Name

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

City

Leszno

ZIP/Postal Code

64-100

Country

Poland

Facility Name

Centrum Medyczne Luxmed Sp z o o

City

Lublin

ZIP/Postal Code

20-109

Country

Poland

Facility Name

Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

City

Pruszcz Gdanski

ZIP/Postal Code

83-000

Country

Poland

Facility Name

Mazowieckie Specjalistyczne Centrum Zdrowia im. Prof. Jana Mazurkiewicza w Pruszkowie

City

Pruszkow

ZIP/Postal Code

05-802

Country

Poland

Facility Name

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

City

Torun

ZIP/Postal Code

87-100

Country

Poland

Facility Name

Sverdlovsk Regional Clinical Psychiatric Hospital

City

Ekaterinburg

Country

Russian Federation

Facility Name

Clinical Psychiatric Hospital #3 Named After V.A. Gilyarovsky

City

Moscow

ZIP/Postal Code

107076

Country

Russian Federation

Facility Name

Psychiatric Clinical hospital 1 named after N.A. Alekseev

City

Moscow

ZIP/Postal Code

117152

Country

Russian Federation

Facility Name

Nizny Novgorod clinical psychiatric hospital 1

City

Nizny Novgorod

ZIP/Postal Code

603155

Country

Russian Federation

Facility Name

SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky

City

Saratov

ZIP/Postal Code

410028

Country

Russian Federation

Facility Name

Saratov Regional Psychiatric hospital named after St. Sofia

City

Saratov

ZIP/Postal Code

410060

Country

Russian Federation

Facility Name

Psychoneurological Dispensary of Frunzensky District

City

St-Petersburg

ZIP/Postal Code

190013

Country

Russian Federation

Facility Name

Psychoneurological dispensary 10

City

St-Petersburg

ZIP/Postal Code

190121

Country

Russian Federation

Facility Name

St-Petersburg Bekhterev Psychoneurological Research Institute

City

St-Petersburg

ZIP/Postal Code

192109

Country

Russian Federation

Facility Name

Psychoneurological dispensary 1

City

St-Petersburg

ZIP/Postal Code

199178

Country

Russian Federation

Facility Name

Psychoneurological Dispensary #4

City

St.Peterburg

ZIP/Postal Code

197110

Country

Russian Federation

Facility Name

Research Institute of Mental Health

City

Tomsk

ZIP/Postal Code

634014

Country

Russian Federation

Facility Name

Flexivest 14 Research

City

Cape Town

ZIP/Postal Code

7550

Country

South Africa

Facility Name

Gert Bosch - Pretoria South Africa

City

Pretoria

ZIP/Postal Code

0042

Country

South Africa

Facility Name

Juan Schrönen - Western Cape South Africa

City

Welgemoed

ZIP/Postal Code

7530

Country

South Africa

Facility Name

Hosp. Univ. Vall D Hebron

City

Barcelona

ZIP/Postal Code

08035

Country

Spain

Facility Name

Inst. Internac. Neurociencias Aplicadas

City

Barcelona

ZIP/Postal Code

8006

Country

Spain

Facility Name

Hosp. Univ. de Basurto

City

Bilbao

ZIP/Postal Code

48013

Country

Spain

Facility Name

Centro Salud Mental La Corredoria

City

Oviedo

ZIP/Postal Code

33011

Country

Spain

Facility Name

Hosp. El Bierzo

City

Ponferrada

ZIP/Postal Code

24404

Country

Spain

Facility Name

Hosp. Clinico Univ. de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hosp. Prov. de Zamora

City

Zamora

ZIP/Postal Code

49021

Country

Spain

Facility Name

National Cheng Kung University Hospital

City

Tainan

ZIP/Postal Code

70403

Country

Taiwan

Facility Name

Mackay Memorial Hospital

City

Taipei

ZIP/Postal Code

10449

Country

Taiwan

Facility Name

Taipei Veterans General Hospital

City

Taipei

ZIP/Postal Code

11217

Country

Taiwan

Facility Name

Chang Gung Memorial Hospital

City

Taoyuan

ZIP/Postal Code

333

Country

Taiwan

Facility Name

Abdurrah Yurtarslan Training and Research Hospital

City

Ankara

ZIP/Postal Code

6200

Country

Turkey

Facility Name

Ankara Numune Research and Training Hospital

City

Ankara

ZIP/Postal Code

6800

Country

Turkey

Facility Name

Erenkoy Mental Health Hospital

City

Istanbul

ZIP/Postal Code

34736

Country

Turkey

Facility Name

Selcuk University, Medical School, Department of Psychiatry

City

Konya

ZIP/Postal Code

42130

Country

Turkey

Facility Name

Sakarya University Medical Faculty Psychiatry Department

City

Sakarya

ZIP/Postal Code

54187

Country

Turkey

Facility Name

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

City

Glevakha

ZIP/Postal Code

8630

Country

Ukraine

Facility Name

Mnpe of Kharkiv Regional Council 'Regional Clinical Psychiatric Hospital #3'

City

Kharkiv

ZIP/Postal Code

61068

Country

Ukraine

Facility Name

CNPE'Kherson Regional Institution of Mental Care'of Kherson Regional Council

City

Kherson

ZIP/Postal Code

73488

Country

Ukraine

Facility Name

Kyiv Territorial Medical Incorporation 'Psychiatry'

City

Kyiv

ZIP/Postal Code

04080

Country

Ukraine

Facility Name

Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

City

Lviv

ZIP/Postal Code

79017

Country

Ukraine

Facility Name

CNCE of the Lviv Regional Council 'Lviv Regional Clinical Psychiatric Hospital'

City

Lviv

ZIP/Postal Code

79021

Country

Ukraine

Facility Name

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

City

Oleksandrivka

ZIP/Postal Code

67513

Country

Ukraine

Facility Name

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

City

Smila

ZIP/Postal Code

20708

Country

Ukraine

Facility Name

CNCE 'Vinnytsya RC Psychoneurological Hospital n.a. O.I. Yushchenko Vinnytsya RC'

City

Vinnytsia

ZIP/Postal Code

21005

Country

Ukraine

12. IPD Sharing Statement

Citations:

PubMed Identifier

34791283

Citation

Najarian D, Sanga P, Wang S, Lim P, Singh A, Robertson MJ, Cohen K, Schotte A, Milz R, Venkatasubramanian R, T'Jollyn H, Walling DP, Galderisi S, Gopal S. A Randomized, Double-Blind, Multicenter, Noninferiority Study Comparing Paliperidone Palmitate 6-Month Versus the 3-Month Long-Acting Injectable in Patients With Schizophrenia. Int J Neuropsychopharmacol. 2022 Mar 17;25(3):238-251. doi: 10.1093/ijnp/pyab071.

Results Reference

derived

Learn more about this trial

A Study of Paliperidone Palmitate 6-Month Formulation

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