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

NCT00111189 | Completed Phase 3

• 2 other identifiers: CR004198R092670PSY3001
• Study Type: interventional
• Target: 414
• Locations: 9 countries
• Sites: 55

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.

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone palmitate; R092670; antipsychotic; recurrence prevention

Outcome Measures

Primary Outcomes (1)

• The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period

  After 68 relapse events

Secondary Outcomes (1)

• Changes from randomization to the end of the recurrence prevention period in PANSS (total and subscales), CGI-S, and PSP. Incidence of adverse events, labs and ECGs throughout study.

  After 68 relapse events

Study Arms (2)

001

EXPERIMENTAL

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

Drug: Paliperidone Palmitate

002

PLACEBO COMPARATOR

Placebo Placebo every 4 wk up to 24 mo

Drug: Placebo

Interventions

Placebo DRUG

Placebo every 4 wk up to 24 mo

002

Paliperidone Palmitate DRUG

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

001

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients unable to provide their own consent
• have been involuntarily committed to psychiatric hospitalization
• have primary, active DSM-IV-TM diagnosis other than schizophrenia
• 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.

Sponsors & Collaborators

• Johnson & Johnson Pharmaceutical Research & Development, L.L.C.: lead
• Janssen-Cilag International NV: collaborator

Study Sites (55)

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Little Rock, Arkansas, United States

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Cerritos, California, United States

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Santa Ana, California, United States

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Hialeah, Florida, United States

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Chicago, Illinois, United States

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Granite City, Illinois, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Flowood, Mississippi, United States

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St Louis, Missouri, United States

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Clementon, New Jersey, United States

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Cedarhurst, New York, United States

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Cleveland, Ohio, United States

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Oklahoma City, Oklahoma, United States

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Conroe, Texas, United States

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DeSoto, Texas, United States

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Irving, Texas, United States

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San Antonio, Texas, United States

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Costa Rica, Costa Rica

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Mexico City, Mexico

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Mérida, Mexico

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Monterrey, Mexico

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Bucharest, Romania

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Cluj-Napoca, Romania

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Iași, Romania

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Sibiu, Romania

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Tg Mures, Romania

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Timișoara, Romania

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Arkhangelsk, Russia

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Moscow, Russia

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Moscow Russia, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Yaroslavl, Russia

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Cape Town, South Africa

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Centurion Gauteng, South Africa

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Florida Johannesburg Gauteng, South Africa

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Johannesburg, South Africa

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Gwangju, South Korea

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Inchun, South Korea

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Pusan, South Korea

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Seoul, South Korea

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Changhua, Taiwan

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Kaohsiung City, Taiwan

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Tainan, Taiwan

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Taoyuan District, Taiwan

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Dnipro, Ukraine

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Hlevakha, Ukraine

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Kharkiv, Ukraine

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Kiev, Ukraine

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Kyiv, Ukraine

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Lviv, Ukraine

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Odesa, Ukraine

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Simferopol, Ukraine

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Vinnitsa, Ukraine

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Related Publications (6)

• 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.

  PMID: 32840872 DERIVED

• 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.

  PMID: 32606705 DERIVED

• 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.

  PMID: 29924507 DERIVED

• 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.

  PMID: 28640988 DERIVED

• 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.

  PMID: 21696265 DERIVED

• 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.

  PMID: 19959339 DERIVED

Related Links

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

MeSH Terms

Conditions

Schizophrenia

Interventions

Paliperidone Palmitate

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Isoxazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Study Officials

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

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 17, 2005
• First Posted: May 18, 2005
• Study Start: February 1, 2005
• Primary Completion: February 1, 2007
• Study Completion: February 1, 2008
• Last Updated: June 20, 2014

Record last verified: 2014-06

Locations

UA (9); RO (6); CO (1); KR (4); RU (6); TW (4); ZA (4); ME (3); US (18)