Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

June 11, 2014 updated by: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.

A Randomized, Double-Blind, Parallel-Group, Comparative Study of Flexible Doses of Paliperidone Palmitate and Flexible Doses of Risperidone Long-Acting Intramuscular Injection in Subjects With Schizophrenia

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

1221

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Linz, Austria
      • Salzburg, Austria
      • Wien, Austria
  • Bulgaria
      • Plovdiv N/A, Bulgaria
      • Varna, Bulgaria
  • Czech Republic
      • Brno, Czech Republic
      • Brno 18, Czech Republic
      • Dobrany N/A, Czech Republic
      • Kromeriz, Czech Republic
      • Kutna Hora, Czech Republic
      • Olomouc 9, Czech Republic
      • Praha, Czech Republic
      • Praha 8, Czech Republic
  • Estonia
      • Pärnu N/A, Estonia
      • Tallinn, Estonia
      • Tartu N/A, Estonia
  • France
      • Bourges Cedex N/A, France
      • Dole Cedex, France
      • Romans Sur Isere Cedex, France
  • Germany
      • Achim, Germany
      • Berlin, Germany
      • Bielefeld, Germany
      • Bochum, Germany
      • Jena, Germany
      • Leipzig, Germany
      • Mannheim, Germany
      • München, Germany
      • Stralsund, Germany
  • Hungary
      • Baja, Hungary
      • Budapest, Hungary
      • Budapest N/A, Hungary
      • Gyõr, Hungary
      • Kalocsa, Hungary
      • Nagykallo N/A, Hungary
  • India
      • Aurangabad, India
      • Bangalore, India
      • Chandigarh, India
      • Mangalore, India
      • Pune, India
      • Varanasi, India
  • Lithuania
      • Alytus, Lithuania
      • Kaunas, Lithuania
      • Klaipeda, Lithuania
      • Vilnius, Lithuania
  • Poland
      • Belchatow, Poland
      • Bytom Na, Poland
      • Chelmno, Poland
      • Gdynia Na, Poland
      • Katowice Woj Slaskie, Poland
      • Krakow Na, Poland
      • Lubliniec, Poland
      • Piekary Slaskie Na, Poland
      • Skorzewo Na, Poland
      • Warszawa Na, Poland
  • Russian Federation
      • Moscow N/A, Russian Federation
      • Moscow Russia, Russian Federation
      • Nizny Novgorod, Russian Federation
      • Saratov N/A, Russian Federation
      • St Petersburg, Russian Federation
      • St Petersburg N/A, Russian Federation
      • St-Petersburg, Russian Federation
      • Yaroslavl, Russian Federation
  • Spain
      • Barcelona, Spain
      • Madrid, Spain
      • San Juan, Spain
  • Ukraine
      • Dnepropetrovsk, Ukraine
      • Donetsk, Ukraine
      • Kharkiv, Ukraine
      • Kiev, Ukraine
      • Kyiv, Ukraine
      • Odessa, Ukraine
      • Simferopol, Ukraine
  • United States
    • Alabama
      • Birmingham, Alabama, United States
    • Arkansas
      • Little Rock, Arkansas, United States
    • California
      • Cerritos, California, United States
      • Garden Grove, California, United States
      • Los Angeles, California, United States
    • District of Columbia
      • Washington, District of Columbia, United States
    • Georgia
      • Atlanta, Georgia, United States
    • Illinois
      • Chicago, Illinois, United States
    • Mississippi
      • Flowood, Mississippi, United States
    • New York
      • Hollis, New York, United States
    • Ohio
      • Willoughby, Ohio, United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
    • Texas
      • Desoto, Texas, United States
      • Houston, Texas, United States
      • Odessa, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Meet diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) criteria as specified by the protocol for at least 1 year before screening
  • Prior medical records, written documentation or verbal information obtained from previous psychiatric providers obtained by the investigator must be consistent with the diagnosis of schizophrenia
  • A total PANSS score between 60 and 120, inclusive, at screening and baseline; Body mass 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 control before study entry and throughout the study as specified by the protocol. Women of childbearing potential must have a negative serum beta-human chorionic gonadotropin (b hCG) pregnancy test result at screening.

Exclusion Criteria:

  • Patient unable to provide consent or involuntarily committed to psychiatric hospitalization; 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 adequate treatments with different antipsychotic medications (an adequate treatment is defined as 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 disease including history of neuroleptic malignant syndrome; History of any severe pre-existing gastrointestinal narrowing or inability to swallow oral study drug whole with the aid of water (applies to those patients requiring oral tolerability only)
  • Significant risk of suicidal or violent behavior, as clinically assessed by the investigator ; History of life-threatening allergic reaction to any drug; Known or suspected 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 experimental medical device within 6 months before screening; History of any active malignancy within 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 the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: RISPERDAL CONSTA
RISPERDAL CONSTA 25-50 mg eq every 2 weeks
Drug: RISPERDAL CONSTA
RISPERDAL CONSTA: Type=exact number, unit=mg, number=25, 37.5, or 50, form=suspension for injection, route=Intramuscular use. One i.m. injection of RISPERDAL CONSTA 25-50 mg eq every 2 weeks at V4, V6, V7, V8, V9, and V10. PALIPERIDONE PALMITATE PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 2 weeks at Baseline and at V4, V7, and V9. RISPERIDONE: Type=up to, unit=mg, number=1 to 6, form=Tablet, route=Oral Use. One tablet for the first 4 weeks (28 days) of the DB treatment period.
Experimental: R092670
Paliperidone Palmitate 50-150 mg eq every 4 wks
Drug: Paliperidone palmitate
PALIPERIDONE PALMITATE: Type=exact number, unit=mg, number=50, 100, or 150, form=suspension for injection, route=Intramuscular use. One i.m. injection of Paliperidone palmitate 50-150 mg eq every 4 wks at Baseline, V4, V7, and V9. RISPERDAL CONSTA PLACEBO: Form=suspension for injection, route=Intramuscular use. One i.m. injection every 4 weeks at Baseline, V4, V7, and V9.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia
Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
The PANSS scale is used to assess the neuropsychiatric symptoms of schizophrenia. The 30-item PANSS scale provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items),and the general psychopathology subscale (16 items), each item rated on a scale of 1 (absent) to 7 (extreme).
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Change From Baseline for the CGI-S Score
Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time. A qualified rater administered the CGI-S.
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]
The Change From Baseline in the PSP Score
Time Frame: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)
The PSP scale is used to assess the degree of dysfunction a patient exhibits over a 7-day period within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numeric score. A score between 71 and 100 indicates a mild degree of difficulty; a score between 31 and 70 indicates a moderate degree of dysfunction, and a patient with a score of 30 or less has functioning so poor he or she requires intensive supervision.
Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

June 1, 2009

Study Completion (Actual)

June 1, 2009

Study Registration Dates

First Submitted

December 21, 2007

First Submitted That Met QC Criteria

December 26, 2007

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 11, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CR012289
  • R092670PSY3006 (Other Identifier: Unique Protocol Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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