Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

Last updated: June 11, 2014
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Overall Status: Completed

Phase

3

Condition

Mood Disorders

Tourette's Syndrome

Schizotypal Personality Disorder (Spd)

Treatment

N/A

Clinical Study ID

NCT00589914
CR012289
R092670PSY3006
  • Ages > 18
  • All Genders

Study Summary

The purpose of this study is to demonstrate the effectiveness of paliperidone palmitate in patients with Schizophrenia.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Meet diagnostic criteria for schizophrenia according to Diagnostic and StatisticalManual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by theprotocol for at least 1 year before screening

  • Prior medical records, written documentation or verbal information obtained fromprevious psychiatric providers obtained by the investigator must be consistent withthe diagnosis of schizophrenia

  • A total PANSS score between 60 and 120, inclusive, at screening and baseline; Bodymass index (BMI) at the screening visit BMI at least 17 kg/m2

  • Female patients must be postmenopausal for at least 2 years, surgically sterile,abstinent, or, if sexually active, be practicing an effective method of birth controlbefore study entry and throughout the study as specified by the protocol. Women ofchildbearing potential must have a negative serum beta-human chorionic gonadotropin (bhCG) pregnancy test result at screening.

Exclusion

Exclusion Criteria:

  • Patient unable to provide consent or involuntarily committed to psychiatrichospitalization; A primary, active DSM-IV diagnosis on Axis I other than schizophrenia

  • A DSM-IV diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)

  • History of treatment resistance as defined by failure to respond to 2 adequatetreatments with different antipsychotic medications (an adequate treatment is definedas a minimum of 6 weeks at maximum tolerated dosage)

  • Relevant history or current presence of any significant or unstable cardiovascular,respiratory, neurologic (including seizures or significant cerebrovascular disease),renal, hepatic, hematologic, endocrine, immunologic, or other systemic diseaseincluding history of neuroleptic malignant syndrome; History of any severepre-existing gastrointestinal narrowing or inability to swallow oral study drug wholewith the aid of water (applies to those patients requiring oral tolerability only)

  • Significant risk of suicidal or violent behavior, as clinically assessed by theinvestigator ; History of life-threatening allergic reaction to any drug; Known orsuspected hypersensitivity or intolerance to risperidone, paliperidone, 20%Intralipid, or any of their excipients (e.g., soybean oil, egg yolks, phospholipids,and glycerol)

  • Have received an experimental drug or experimental biologic, or used an experimentalmedical device within 6 months before screening; History of any active malignancywithin the previous 5 years, with the exception of basal cell carcinomas

  • Women who are pregnant or breast-feeding or are planning to become pregnant uring thestudy

Study Design

Total Participants: 1221
Study Start date:
March 01, 2007
Estimated Completion Date:
June 30, 2009

Study Description

This is a randomized (patients assigned to treatment groups by chance), double-blind (patient and study staff will not know the treatment assignment) study of paliperidone palmitate compared with RISPERDAL CONSTA (Risperidone Long-Acting Intramuscular Injection) in adult patients with schizophrenia. The total duration of the study will be approximately 14 weeks. For those patients without source documentation of tolerability to oral (by mouth) risperidone or paliperidone Extended Release (ER) tablets, injectable RISPERDAL CONSTA or paliperidone palmitate, or those patients who were not currently taking another antipsychotic, a minimum of 4 days and a maximum of 6 days of oral paliperidone ER treatment at a dosage of 6 mg/day will be administered for tolerability testing before the first injection of double-blind (DB) study drug (paliperidone palmitate or RISPERDAL CONSTA). During the DB period, study drug will be administered to patients as an intramuscular (i.m.) injection. Paliperidone palmitate (PP) 150mg equivalent (eq) (and RISPERDAL CONSTA placebo) at Baseline (BL) (Day 1), 100mg eq at Visit (V) 4 (Day 8), 50 or 100mg eq at V7 (Day 36), and 50,100,or 150mg eq at V9 (Day 64) or RISPERDAL CONSTA (RC) 25mg at V4 and V6 (Day 22), 25 or 37.5mg at V7, and 25, 37.5, or 50mg at V9 will be given as i.m. injections. Patients in the RC group will also take risperidone tablets (1-6 mg/day) at BL for 28 days and be given an injection of PP placebo at BL, V1, V7, and V9.

Connect with a study center

  • Linz,
    Austria

    Site Not Available

  • Salzburg,
    Austria

    Site Not Available

  • Wien,
    Austria

    Site Not Available

  • Plovdiv N/A,
    Bulgaria

    Site Not Available

  • Varna,
    Bulgaria

    Site Not Available

  • Brno,
    Czech Republic

    Site Not Available

  • Brno 18,
    Czech Republic

    Site Not Available

  • Dobrany N/A,
    Czech Republic

    Site Not Available

  • Kromeriz,
    Czech Republic

    Site Not Available

  • Kutna Hora,
    Czech Republic

    Site Not Available

  • Olomouc 9,
    Czech Republic

    Site Not Available

  • Praha,
    Czech Republic

    Site Not Available

  • Praha 8,
    Czech Republic

    Site Not Available

  • empty

    Pärnu N/A,
    Estonia

    Site Not Available

  • Pärnu N/A,
    Estonia

    Site Not Available

  • Tallinn,
    Estonia

    Site Not Available

  • Tartu N/A,
    Estonia

    Site Not Available

  • Bourges Cedex N/A,
    France

    Site Not Available

  • Dole Cedex,
    France

    Site Not Available

  • Romans Sur Isere Cedex,
    France

    Site Not Available

  • Achim,
    Germany

    Site Not Available

  • Berlin,
    Germany

    Site Not Available

  • Bielefeld,
    Germany

    Site Not Available

  • Bochum,
    Germany

    Site Not Available

  • Jena,
    Germany

    Site Not Available

  • Leipzig,
    Germany

    Site Not Available

  • Mannheim,
    Germany

    Site Not Available

  • empty

    München,
    Germany

    Site Not Available

  • München,
    Germany

    Site Not Available

  • Stralsund,
    Germany

    Site Not Available

  • Baja,
    Hungary

    Site Not Available

  • empty

    Baja N/A,
    Hungary

    Site Not Available

  • Budapest,
    Hungary

    Site Not Available

  • Budapest N/A,
    Hungary

    Site Not Available

  • empty

    Gyõr,
    Hungary

    Site Not Available

  • Gyõr,
    Hungary

    Site Not Available

  • Kalocsa,
    Hungary

    Site Not Available

  • Nagykallo N/A,
    Hungary

    Site Not Available

  • Aurangabad,
    India

    Site Not Available

  • Bangalore,
    India

    Site Not Available

  • Chandigarh,
    India

    Site Not Available

  • Mangalore,
    India

    Site Not Available

  • Pune,
    India

    Site Not Available

  • Varanasi,
    India

    Site Not Available

  • Alytus,
    Lithuania

    Site Not Available

  • Kaunas,
    Lithuania

    Site Not Available

  • Klaipeda,
    Lithuania

    Site Not Available

  • Vilnius,
    Lithuania

    Site Not Available

  • Belchatow,
    Poland

    Site Not Available

  • Bytom Na,
    Poland

    Site Not Available

  • Chelmno,
    Poland

    Site Not Available

  • Gdynia Na,
    Poland

    Site Not Available

  • Katowice Woj Slaskie,
    Poland

    Site Not Available

  • Krakow Na,
    Poland

    Site Not Available

  • Lubliniec,
    Poland

    Site Not Available

  • Piekary Slaskie Na,
    Poland

    Site Not Available

  • Skorzewo Na,
    Poland

    Site Not Available

  • Warszawa Na,
    Poland

    Site Not Available

  • Moscow N/A,
    Russian Federation

    Site Not Available

  • Moscow Russia,
    Russian Federation

    Site Not Available

  • Nizny Novgorod,
    Russian Federation

    Site Not Available

  • Saratov N/A,
    Russian Federation

    Site Not Available

  • St Petersburg,
    Russian Federation

    Site Not Available

  • St Petersburg N/A,
    Russian Federation

    Site Not Available

  • St-Petersburg,
    Russian Federation

    Site Not Available

  • Yaroslavl,
    Russian Federation

    Site Not Available

  • empty

    Yaroslavl N/A,
    Russian Federation

    Site Not Available

  • Barcelona,
    Spain

    Site Not Available

  • Madrid,
    Spain

    Site Not Available

  • San Juan,
    Spain

    Site Not Available

  • Dnepropetrovsk,
    Ukraine

    Site Not Available

  • Donetsk,
    Ukraine

    Site Not Available

  • Kharkiv,
    Ukraine

    Site Not Available

  • Kiev,
    Ukraine

    Site Not Available

  • Kyiv,
    Ukraine

    Site Not Available

  • Odessa,
    Ukraine

    Site Not Available

  • Simferopol,
    Ukraine

    Site Not Available

  • Birmingham, Alabama
    United States

    Site Not Available

  • Little Rock, Arkansas
    United States

    Site Not Available

  • Cerritos, California
    United States

    Site Not Available

  • Garden Grove, California
    United States

    Site Not Available

  • Los Angeles, California
    United States

    Site Not Available

  • Washington, District of Columbia
    United States

    Site Not Available

  • Atlanta, Georgia
    United States

    Site Not Available

  • Chicago, Illinois
    United States

    Site Not Available

  • Flowood, Mississippi
    United States

    Site Not Available

  • Hollis, New York
    United States

    Site Not Available

  • Willoughby, Ohio
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Desoto, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Odessa, Texas
    United States

    Site Not Available

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