A Study of the Efficacy (Effectiveness) of Paliperidone Palmitate in the Prevention of Recurrence of the Symptoms of Schizophrenia.

NCT ID: NCT00111189

Last Updated: 2014-06-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 414 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-02-28
• Study Completion Date: 2008-02-29

Brief Summary

The purpose of this study is to evaluate the efficacy of paliperidone palmitate compared with placebo in the prevention of recurrence of the symptoms of schizophrenia and to assess the safety and tolerability of paliperidone palmitate in patients with stable and symptomatic schizophrenia. The placebo used in this study was a nutritional substance known as 20% Intralipid emulsion given to patients requiring intravenous feedings.

Detailed Description

Many patients with schizophrenia have difficulty adhering to a daily oral treatment regimen. Long-acting injectable formulations, such as long-acting injectable paliperidone palmitate, may provide therapeutic plasma concentrations over several weeks, thereby eliminating the need for daily oral medication and making compliance easier. This study is a randomized (patients will be assigned to different treatment groups based solely on chance), double-blind (neither the patient nor the physician will know if placebo or drug is being given and at what dose), placebo-controlled, parallel-group, multicenter study followed by an open-label extension period in patients with schizophrenia. The study is designed to evaluate the efficacy of paliperidone palmitate (a long-acting injectable formulation) in delaying the time to and decreasing the rate of recurrence compared with placebo in patients with schizophrenia. The study will consist of 5 periods: an up to 7-day screening/washout/tolerability period, a 9-week open-label transition period, a 24-week open-label maintenance period, a randomized, variable-length double-blind, placebo-controlled recurrence prevention period, and an up to 52-week open-label extension period. Patients will have intramuscular (i.m.) study drug injections and efficacy and safety evaluations performed every 4 weeks throughout the study. Efficacy will be evaluated during the study using a recurrence assessment, the Positive and Negative Symptom Scale for Schizophrenia (PANSS), the Clinical Global Impression - Severity (CGI-S) scale, and the Personal and Social Performance (PSP) scale. Safety will be assessed throughout the study by monitoring adverse events; use of extrapyramidal symptoms (EPS) rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson Angus Scale [SAS]); clinical laboratory testing; vital signs (temperature, blood pressure, and heart rate) measurements; electrocardiograms (ECGs); and physical examinations. Additionally, the patients will assess the tolerability of the injections by evaluating the pain of the injection and the pain at the injection sites. Tolerability test: 3 mg/day of oral ER OROS paliperidone for 4 days. Transition (9 wks): 50 mg eq. paliperidone palmitate i.m. dose on Day 1, then i.m. injections (25, 50, or 100 mg eq.) once every 4 wks (q4wk). Maintenance (24-wks): paliperidone palmitate i.m. injections (25, 50, or 100 mg eq.) q4wk. Recurrence Prevention: paliperidone palmitate i.m. injections (25, 50, or 100 mg eq. or placebo) q4wk. Open-label paliperidone palmitate (25, 50, 75, or 100 mg eq.) q4wk for 12 dosing periods.

Conditions

Schizophrenia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

001

Paliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo

Group Type: EXPERIMENTAL

Paliperidone Palmitate

Intervention Type: DRUG

25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo

002

Placebo Placebo every 4 wk up to 24 mo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo every 4 wk up to 24 mo

Interventions

Placebo

Placebo every 4 wk up to 24 mo

Intervention Type: DRUG

Paliperidone Palmitate

25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Patients who meet the diagnostic criteria for schizophrenia according to DSM-IV-TM for at least 1 year before screening
• have a PANSS score of <120
• have a body mass index (BMI) >/=15.0 kilogram (kg)/meter (m)2
• and have resided at the same address for at least 30 days

Exclusion Criteria

• Patients unable to provide their own consent
• have been involuntarily committed to psychiatric hospitalization
• have primary, active DSM-IV-TM diagnosis other than schizophrenia
• who have a DSM-IV-TM diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
• have a history of treatment resistance as defined by failure to respond to 2 adequate trials (minimum of 4 weeks at a therapeutic dose) of different antipsychotic medications
• have a history of any severe preexisting gastrointestinal narrowing or inability to swallow the medication whole with water
• have a history of neuroleptic malignant syndrome (NMS)
• are at significant risk of suicidal or violent behavior
• current presence of any significant or unstable medication condition
• treatment with any protocol disallowed therapies
• clinically significant result from screening laboratory or ECG.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Janssen-Cilag International NV

INDUSTRY

Sponsor Role: collaborator

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial

Role: STUDY_DIRECTOR

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

Locations

Little Rock, Arkansas, United States

Cerritos, California, United States

Santa Ana, California, United States

Hialeah, Florida, United States

Chicago, Illinois, United States

Granite City, Illinois, United States

Lake Charles, Louisiana, United States

Shreveport, Louisiana, United States

Flowood, Mississippi, United States

St Louis, Missouri, United States

Clementon, New Jersey, United States

Cedarhurst, New York, United States

Cleveland, Ohio, United States

Oklahoma City, Oklahoma, United States

Conroe, Texas, United States

DeSoto, Texas, United States

Irving, Texas, United States

San Antonio, Texas, United States

Costa Rica, , Costa Rica

Mexico City, , Mexico

Mérida, , Mexico

Monterrey, , Mexico

Bucharest, , Romania

Cluj-Napoca, , Romania

Iași, , Romania

Sibiu, , Romania

Tg Mures, , Romania

Timișoara, , Romania

Arkhangelsk, , Russia

Moscow, , Russia

Moscow Russia, , Russia

Saint Petersburg, , Russia

Samara, , Russia

Yaroslavl, , Russia

Cape Town, , South Africa

Centurion Gauteng, , South Africa

Florida Johannesburg Gauteng, , South Africa

Johannesburg, , South Africa

Gwangju, , South Korea

Inchun, , South Korea

Pusan, , South Korea

Seoul, , South Korea

Changhua, , Taiwan

Kaohsiung City, , Taiwan

Tainan City, , Taiwan

Taoyuan District, , Taiwan

Dnipro, , Ukraine

Hlevakha, , Ukraine

Kharkiv, , Ukraine

Kiev, , Ukraine

Kyiv, , Ukraine

Lviv, , Ukraine

Odesa, , Ukraine

Simferopol, , Ukraine

Vinnitsa, , Ukraine

Countries

United States; Costa Rica; Mexico; Romania; Russia; South Africa; South Korea; Taiwan; Ukraine

References

Ceraso A, Lin JJ, Schneider-Thoma J, Siafis S, Tardy M, Komossa K, Heres S, Kissling W, Davis JM, Leucht S. Maintenance treatment with antipsychotic drugs for schizophrenia. Cochrane Database Syst Rev. 2020 Aug 11;8(8):CD008016. doi: 10.1002/14651858.CD008016.pub3.

Reference Type: DERIVED

PMID: 32840872 (View on PubMed)

Mathews M, Gopal S, Singh A, Nuamah I, Pungor K, Tan W, Soares B, Kim E, Savitz AJ. Comparison of Relapse Prevention with 3 Different Paliperidone Formulations in Patients with Schizophrenia Continuing versus Discontinuing Active Antipsychotic Treatment: A Post-Hoc Analysis of 3 Similarly Designed Randomized Studies. Neuropsychiatr Dis Treat. 2020 Jun 19;16:1533-1542. doi: 10.2147/NDT.S221242. eCollection 2020.

Reference Type: DERIVED

PMID: 32606705 (View on PubMed)

Emsley R, Nuamah I, Gopal S, Hough D, Fleischhacker WW. Relapse After Antipsychotic Discontinuation in Schizophrenia as a Withdrawal Phenomenon vs Illness Recurrence: A Post Hoc Analysis of a Randomized Placebo-Controlled Study. J Clin Psychiatry. 2018 Jun 19;79(4):17m11874. doi: 10.4088/JCP.17m11874.

Reference Type: DERIVED

PMID: 29924507 (View on PubMed)

Weiden PJ, Kim E, Bermak J, Turkoz I, Gopal S, Berwaerts J. Does Half-Life Matter After Antipsychotic Discontinuation? A Relapse Comparison in Schizophrenia With 3 Different Formulations of Paliperidone. J Clin Psychiatry. 2017 Jul;78(7):e813-e820. doi: 10.4088/JCP.16m11308.

Reference Type: DERIVED

PMID: 28640988 (View on PubMed)

Kozma CM, Slaton T, Dirani R, Fastenau J, Gopal S, Hough D. Changes in schizophrenia-related hospitalization and ER use among patients receiving paliperidone palmitate: results from a clinical trial with a 52-week open-label extension (OLE). Curr Med Res Opin. 2011 Aug;27(8):1603-11. doi: 10.1185/03007995.2011.595000. Epub 2011 Jun 22.

Reference Type: DERIVED

PMID: 21696265 (View on PubMed)

Hough D, Gopal S, Vijapurkar U, Lim P, Morozova M, Eerdekens M. Paliperidone palmitate maintenance treatment in delaying the time-to-relapse in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. Schizophr Res. 2010 Feb;116(2-3):107-17. doi: 10.1016/j.schres.2009.10.026. Epub 2009 Dec 2.

Reference Type: DERIVED

PMID: 19959339 (View on PubMed)

Related Links

http://filehosting.pharmacm.com/DownloadService.ashx?client=CTR_JNJ_6051&studyid=564&filename=CR004198_CSR.pdf

A study of the efficacy of paliperidone palmitate in the prevention of recurrence of the symptoms of schizophrenia

Other Identifiers

R092670PSY3001

Identifier Type: -

Identifier Source: secondary_id

CR004198

Identifier Type: -

Identifier Source: org_study_id