A Study of Paliperidone Palmitate 6-Month Formulation

• ClinicalTrials.gov Identifier: NCT03345342
• Recruitment Status: Completed
• First Posted: November 17, 2017
• Results First Posted: December 9, 2021
• Last Update Posted: October 13, 2022
• Sponsor: Janssen Research & Development, LLC
• Information provided by (Responsible Party): Janssen Research & Development, LLC

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.).

Condition or disease	Intervention/treatment	Phase
Schizophrenia	Drug: PP6M; Drug: PP3M 350 mg eq.; Drug: PP3M 525 mg eq.; Drug: PP1M; Other: Placebo	Phase 3

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 841 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: A Double-blind, Randomized, Active-controlled, Parallel-group Study of Paliperidone Palmitate 6-Month Formulation
• Actual Study Start Date: November 20, 2017
• Actual Primary Completion Date: May 8, 2020
• Actual Study Completion Date: May 8, 2020

Arms and Interventions

Arm	Intervention/treatment
Experimental: PP1M: Transition Phase; 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.	Drug: PP1M; Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.; Other Name: R092670
Experimental: PP1M/PP3M: 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.	Drug: PP3M 350 mg eq.; Participants will receive intramuscular injection of PP3M 350 mg eq.; Other Name: R092670; Drug: PP3M 525 mg eq.; Participants will receive intramuscular injection of PP3M 525 mg eq.; Other Name: R092670; Drug: PP1M; Participants will receive intramuscular injection of PP1M 50 to 150 mg eq.; Other Name: R092670
Experimental: PP6M or Placebo: 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.	Drug: PP6M; Participants will receive intramuscular injection of PP6M.; Other Name: R092670; Other: Placebo; Participants will receive matching placebo.
Experimental: PP3M: Double-Blind Phase; 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.	Drug: PP3M 350 mg eq.; Participants will receive intramuscular injection of PP3M 350 mg eq.; Other Name: R092670; Drug: PP3M 525 mg eq.; Participants will receive intramuscular injection of PP3M 525 mg eq.; Other Name: R092670

Outcome Measures

Primary Outcome Measures :

1. Time to Relapse During the Double-Blind (DB) Phase [ Time Frame: Up to 12 months of 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 :

1. Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score [ Time Frame: Baseline (DB) to 12 Months of 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: 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).
2. Change From Baseline in the Clinical Global Impression - Severity (CGI-S) Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
3. Change From Baseline in the Personal and Social Performance (PSP) Scale Total Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
4. Percentage of Participants With Symptomatic Remission Based on PANSS Score During DB Phase [ Time Frame: Up to 12 months of 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.
5. Change From Baseline in the Satisfaction With Participants in Social Roles (SPSR) Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
6. Change From Baseline in the Treatment Satisfaction Questionnaire for Medication (TSQM-9) Total Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
7. Change From Baseline in the Simpson-Angus Rating Scale (SAS) Total Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
8. Number of Participants With Symptoms of Akathisia Assessed Using Barnes Akathisia Rating Scale (BARS) Score [ Time Frame: Up to 12 Months of DB Phase ]
   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).
9. Change From Baseline in the Abnormal Involuntary Movement Scale (AIMS) Total Score [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
   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.
10. Number of Participants Based on Columbia Suicide Severity Rating Scale (C-SSRS) Total Score [ Time Frame: Baseline and endpoint (12 Months of DB Phase) ]
    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.
11. Number of Participants With Treatment-emergent Abnormal Electrocardiogram (ECG) Values During DB Phase [ Time Frame: Baseline (DB) to 12 Months of 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).
12. Change From Baseline in the Body Mass Index (BMI) During DB Phase [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
    Change from baseline in BMI was reported.
13. Change From Baseline in the Waist Circumference During DB Phase [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
    Change from baseline in waist circumference was reported.
14. Change From Baseline in the Body Weight During DB Phase [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
    Change from baseline in body weight was reported.
15. Change From Baseline in the Vital Signs (Pulse Rate) During DB Phase [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
    Change from baseline vital signs (pulse rate) were reported. This included supine pulse rate, standing pulse rate and supine-standing pulse rate.
16. Change From Baseline in the Vital Signs (Systolic Blood Pressure [SBP] and Diastolic Blood Pressure [DBP]) During DB Phase [ Time Frame: Baseline (DB) to 12 Months of DB Phase ]
    Change from baseline in vital signs including SBP and DBP (supine/standing) were reported.
17. Change From Baseline in Positive and Syndrome Scale (PANSS) Subscales Score During DB Phase [ Time Frame: Baseline (DB) to 12 Months of 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).
18. Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Chemistry During DB Phase [ Time Frame: Up to 12 Months of 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.
19. Number of Participants With Treatment-emergent Clinically Significant Abnormal Laboratory Values in Hematology During DB Phase [ Time Frame: Up to 12 Months of 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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Arkansas

Woodland Research Northwest

Rogers, Arkansas, United States, 72758

United States, California

California Pharmaceutical Research Institute, Inc.

Anaheim, California, United States, 92804

ATP Clinical Research

Costa Mesa, California, United States, 92626

Collaborative NeuroScience Network

Garden Grove, California, United States, 92845

Synergy East

Lemon Grove, California, United States, 91945

Pacific Research Partners

Oakland, California, United States, 94607

SF-Care, Inc

San Rafael, California, United States, 94901

United States, Florida

New Life Medical Research Center, Inc.

Hialeah, Florida, United States, 33012

Clintex Research Group

Miami, Florida, United States, 33135

Florida Research Center Inc.

Miami, Florida, United States, 33174

Olympian Clinical Research

Tampa, Florida, United States, 33614

United States, Georgia

Atlanta Center for Medical Research

Atlanta, Georgia, United States, 30331

United States, Illinois

Uptown Research Institute

Chicago, Illinois, United States, 60640

Alexian Behavioral Health Hospital

Hoffman Estates, Illinois, United States, 60169

United States, Kansas

Ascension via Christi Research

Wichita, Kansas, United States, 67214

United States, Massachusetts

Massachusetts General Hospital

Boston, Massachusetts, United States, 02114

United States, Michigan

Cherry Street Services, Inc.

Grand Rapids, Michigan, United States, 49503

United States, Missouri

St. Louis Clinical Trials

Saint Louis, Missouri, United States, 63141

United States, New York

The Zucker Hillside Hospital

Glen Oaks, New York, United States, 11004

United States, North Carolina

Clinical Trials of America Inc

Hickory, North Carolina, United States, 28601

United States, Ohio

Wexner Medical Center at the Ohio State University

Columbus, Ohio, United States, 43210

Midwest Clinical Research Center

Dayton, Ohio, United States, 45417

United States, Pennsylvania

University of Pennsylvania Medical Center

Philadelphia, Pennsylvania, United States, 19104

United States, Texas

Future Search Trials of Dallas

Dallas, Texas, United States, 75231

United States, Utah

Psychiatric and Behavioral Solutions

Salt Lake City, Utah, United States, 84105-2425

Argentina

Fundación para el Estudio y Tratamiento de las Enfermedades Mentales

Ciudad Autónoma De Buenos Aires, Argentina, C1133AAH

CEN

Cordoba, Argentina, X5004FJF

Sanatorio Prof. Leon S. Morra

Cordoba, Argentina, X5009BIN

Instituto de Neurociencias San Agustín

La Plata, Argentina, 1900

Clinica Privada de Salud Mental Santa Teresa de Ávila

La Plata, Argentina, B1904ADM

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

Rosario, Argentina, 2000

Australia

The Lyell McEwin Hospital

Elizabeth Vale, Australia, 5112

Neuro Trials Victoria

Noble Park, Australia, 3174

Brazil

Trial Tech Tecnologia em Pesquisas com Medicamentos

Curitiba, Brazil, 80240-280

Instituto Bairral de Psiquiatria

Itapira, Brazil, 13970-905

Hospital das Clinicas de Porto Alegre

Porto Alegre, Brazil, 90035-903

Ruschel Medicina e Pesquisa Clínica Ltda

Rio de Janeiro, Brazil, 22270-060

Proesq - Unifesp

Sao Paulo, Brazil, 04020-060

CPQuali Pesquisa Clinica LTDA ME

São Paulo, Brazil, 01228-900

Instituto de Psiquiatria - Hcfmusp

São Paulo, Brazil, 05403010

Bulgaria

Mental Health Center Prof. Dr. Ivan Temkov

Bourgas, Bulgaria, 8001

State Psychiatric Hospital Pazardzhik

Pazardzhik, Bulgaria, 4400

UMHAT 'Sveti Georgi'-Plovdiv

Plovdiv, Bulgaria, 4002

State Psychiatric HospitalDr.Georgi Kissiov

Radnevo, Bulgaria, 6260

Centre for Mental Health Prof.N.Shipkovenski EOOD

Sofia, Bulgaria, 1377

Medical Center Intermedica, OOD

Sofia, Bulgaria, 1680

Czechia

Psychiatricka ambulance, MUDr. Marta Holanova

Brno, Czechia, 61500

NeuropsychiatrieHK, s.r.o.

Hradec Kralove-Vekose, Czechia, 50341

A-Shine s.r.o.

Plzen, Czechia, 31200

Institut Neuropsychiatricke pece

Prague, Czechia, 18600

Psychiatricka ambulance MUDr. Simona Papezova

Prague, Czechia, 19000

PRAGTIS s.r.o.

Praha 2, Czechia, 12000

France

C.H.S. Charles Perrens

Bordeaux, France, 33076

CHRU La Colombière

Montpellier, France, 34090

CHU Caremeau

Nimes Cedex 9, France, 30029

Hopital Sainte Anne

Paris, France, 75674

Hôpital Sainte Musse

Toulon Cedex, France, 83000

Hong Kong

Kwai Chung Hospital

Hong Kong, Hong Kong

Queen Mary Hospital

Hong Kong, Hong Kong

Hungary

Józsefvarosi Szent Kozma Egészségügyi Központ

Budapest, Hungary, 1084

Petz Aladar Megyei Oktato Korhaz

Győr, Hungary, 9023

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

Kalocsa, Hungary, 6300

CRU Hungary Kft.

Miskolc, Hungary, 3529

India

Ratandeep Multispeciality Hospital

Ahmedabad, India, 380008

Sri Ramachandra Medical Centre

Chennai, India, 600116

Asha hospital

Hyderabad, India, 500034

Ahana Hospitals

Madurai, India, 625020

Vinaya Hospital and Research Center

Mangalore, India, 575003

Kasturba Medical College Hospital

Manipal, India, 576104

Jehangir Clinical Development Center Pvt Ltd

Pune, India, 411001

Deva Institute of Health Care and Research Pvt Ltd

Varanasi, India, 221005

Italy

Clinica Psichiatrica - Università di Cagliari

Cagliari, Italy, 09127

Dipartimento di Salute Mentale

Lecce, Italy, 73100

Seconda Universita degli Studi di Napoli - Azienda Ospedaliera Universitaria

Napoli, Italy, 80138

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

Roma, Italy, 00189

Korea, Republic of

Chonnam National University Hospital

Gwangju, Korea, Republic of, 61469

CHA Bundang Medical Center, CHA University

Gyeonggi-do, Korea, Republic of, 13496

Chonbuk National Univ Hospital

Jeonju, Korea, Republic of, 54907

Seoul National University Hospital

Seoul, Korea, Republic of, 03080

Malaysia

Hospital Bahagia Ulu Kinta

Ipoh, Malaysia, 31250

Hospital Kuala Lumpur

Kuala Lumpur, Malaysia, 50586

University Malaya Medical Centre

Kuala Lumpur, Malaysia, 59100

Sarawak General Hospital

Kuching, Malaysia, 93586

Mexico

Gabipros SC.

Mexico City, Mexico, 07810

Instituto Neuropsique

Monterrey, Mexico, 64610

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

Monterrey, Mexico, 64620

Infosame/Research

Monterrey, Mexico, 64710

Centro de Atención e Investigación Cardiovascular del Potosí, S.C.

San Luis Potosí, Mexico, 78200

Poland

Mlynowamed Specjalistyczny Psychiatryczny Gabinet Lekarski Joanna Lazarczyk

Bialystok, Poland, 15-404

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

Bialystok, Poland, 15-464

Zespol Opieki Zdrowotnej w Chelmnie

Chelmno, Poland, 86-200

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

Gdansk, Poland, 80-546

Szpital Specjalistyczny im. H. Klimontowicza, Oddzial Psychiatryczny

Gorlice, Poland, 38-300

Niepubliczny Zaklad Opieki Psychiatrycznej MENTIS

Leszno, Poland, 64-100

Centrum Medyczne Luxmed Sp z o o

Lublin, Poland, 20-109

Poradnia Zdrowia Psychicznego 'Syntonia' w Pruszczu Gdanskim

Pruszcz Gdanski, Poland, 83-000

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

Pruszkow, Poland, 05-802

Wojewodzki Szpital Zespolony im. L. Rydygiera w Toruniu

Torun, Poland, 87-100

Russian Federation

Sverdlovsk Regional Clinical Psychiatric Hospital

Ekaterinburg, Russian Federation

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

Moscow, Russian Federation, 107076

Psychiatric Clinical hospital 1 named after N.A. Alekseev

Moscow, Russian Federation, 117152

Nizny Novgorod clinical psychiatric hospital 1

Nizny Novgorod, Russian Federation, 603155

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

Saratov, Russian Federation, 410028

Saratov Regional Psychiatric hospital named after St. Sofia

Saratov, Russian Federation, 410060

Psychoneurological Dispensary of Frunzensky District

St-Petersburg, Russian Federation, 190013

Psychoneurological dispensary 10

St-Petersburg, Russian Federation, 190121

St-Petersburg Bekhterev Psychoneurological Research Institute

St-Petersburg, Russian Federation, 192109

Psychoneurological dispensary 1

St-Petersburg, Russian Federation, 199178

Psychoneurological Dispensary #4

St.Peterburg, Russian Federation, 197110

Research Institute of Mental Health

Tomsk, Russian Federation, 634014

South Africa

Flexivest 14 Research

Cape Town, South Africa, 7550

Gert Bosch - Pretoria South Africa

Pretoria, South Africa, 0042

Juan Schrönen - Western Cape South Africa

Welgemoed, South Africa, 7530

Spain

Hosp. Univ. Vall D Hebron

Barcelona, Spain, 08035

Inst. Internac. Neurociencias Aplicadas

Barcelona, Spain, 8006

Hosp. Univ. de Basurto

Bilbao, Spain, 48013

Centro Salud Mental La Corredoria

Oviedo, Spain, 33011

Hosp. El Bierzo

Ponferrada, Spain, 24404

Hosp. Clinico Univ. de Valencia

Valencia, Spain, 46010

Hosp. Prov. de Zamora

Zamora, Spain, 49021

Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan, 70403

Mackay Memorial Hospital

Taipei, Taiwan, 10449

Taipei Veterans General Hospital

Taipei, Taiwan, 11217

Chang Gung Memorial Hospital

Taoyuan, Taiwan, 333

Turkey

Abdurrah Yurtarslan Training and Research Hospital

Ankara, Turkey, 6200

Ankara Numune Research and Training Hospital

Ankara, Turkey, 6800

Erenkoy Mental Health Hospital

Istanbul, Turkey, 34736

Selcuk University, Medical School, Department of Psychiatry

Konya, Turkey, 42130

Sakarya University Medical Faculty Psychiatry Department

Sakarya, Turkey, 54187

Ukraine

MNCE of Kyiv RC Regional Psychiatric and Narcological Medical Association

Glevakha, Ukraine, 8630

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

Kharkiv, Ukraine, 61068

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

Kherson, Ukraine, 73488

Kyiv Territorial Medical Incorporation 'Psychiatry'

Kyiv, Ukraine, 04080

Municipal Institution 'Lviv Regional Clinical Psycho-Neurological Dispensary'

Lviv, Ukraine, 79017

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

Lviv, Ukraine, 79021

CNCE Odesa regional psychiatric hospital #2 Odesa regional council

Oleksandrivka, Ukraine, 67513

CNCE 'Cherkasy Regional Psychiatric Hospital of Cherkasy Regional Council'

Smila, Ukraine, 20708

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

Vinnytsia, Ukraine, 21005

Sponsors and Collaborators

Janssen Research & Development, LLC

Investigators

• Study Director: Janssen Research & Development, LLC Clinical Trial; Janssen Research & Development, LLC

  Study Documents (Full-Text)

Documents provided by Janssen Research & Development, LLC:

Study Protocol  [PDF] February 11, 2019

Statistical Analysis Plan  [PDF] May 26, 2020

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Janssen Research & Development, LLC
• ClinicalTrials.gov Identifier: NCT03345342
• Other Study ID Numbers: CR108390; R092670PSY3015 ( Other Identifier: Janssen Research & Development, LLC ); 2017-001941-28 ( EudraCT Number )
• First Posted: November 17, 2017
• Results First Posted: December 9, 2021
• Last Update Posted: October 13, 2022
• Last Verified: October 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:

Schizophrenia; Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders