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SchizophreniaPhase 3NCT00589914

Comparison of Paliperidone Palmitate and RISPERDAL CONSTA in Patients With Schizophrenia

A Phase 3 study testing RISPERDAL CONSTA and Paliperidone palmitate in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 82 sites in 14 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
RISPERDAL CONSTA and Paliperidone palmitate
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,221 participants
Where
82 sitesin 14 countries
Study dates
Mar 2007to Jun 2009
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

82 sites in 14 countries.

82 sites in 14 countries

United States15 sites

  • Study site

    Atlanta, Georgia

  • Study site

    Birmingham, Alabama

  • Study site

    Cerritos, California

  • Study site

    Chicago, Illinois

  • Study site

    DeSoto, Texas

  • Study site

    Flowood, Mississippi

  • Study site

    Garden Grove, California

  • Study site

    Hollis, New York

  • Study site

    Houston, Texas

  • Study site

    Little Rock, Arkansas

  • Study site

    Los Angeles, California

  • Study site

    Odessa, Texas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Washington D.C., District of Columbia

  • Study site

    Willoughby, Ohio

Other trials in United States

Poland10 sites

  • Study site

    Bełchatów

  • Study site

    Bytom Na

  • Study site

    Chełmno

  • Study site

    Gdynia Na

  • Study site

    Katowice Woj Slaskie

  • Study site

    Krakow Na

  • Study site

    Lubliniec

  • Study site

    Piekary Slaskie Na

  • Study site

    Skorzewo Na

  • Study site

    Warszawa Na

Other trials in Poland

Germany9 sites

  • Study site

    Achim

  • Study site

    Berlin

  • Study site

    Bielefeld

  • Study site

    Bochum

  • Study site

    Jena

  • Study site

    Leipzig

  • Study site

    Mannheim

  • Study site

    München

  • Study site

    Stralsund

Other trials in Germany

Ukraine7 sites

  • Study site

    Dnipro

  • Study site

    Donetsk

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Odesa

  • Study site

    Simferopol

Other trials in Ukraine

Czechia6 sites

  • Study site

    Brno

  • Study site

    Dobřany

  • Study site

    Kroměříž

  • Study site

    Kutná Hora

  • Study site

    Olomouc

  • Study site

    Prague

Other trials in Czechia

India6 sites

  • Study site

    Bangalore

  • Study site

    Chandigarh

  • Study site

    Chhatrapati Sambhajinagar

  • Study site

    Mangalore

  • Study site

    Pune

  • Study site

    Varanasi

Other trials in India

Russia6 sites

  • Study site

    Moscow

  • Study site

    Moscow Russia

  • Study site

    Nizny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Saratov

  • Study site

    Yaroslavl

Other trials in Russia

Hungary5 sites

  • Study site

    Baja

  • Study site

    Budapest

  • Study site

    Gyõr

  • Study site

    Kalocsa

  • Study site

    Nagykálló

Other trials in Hungary

Lithuania4 sites

  • Study site

    Alytus

  • Study site

    Kaunas

  • Study site

    Klaipėda

  • Study site

    Vilnius

Other trials in Lithuania

Austria3 sites

  • Study site

    Linz

  • Study site

    Salzburg

  • Study site

    Vienna

Other trials in Austria

Estonia3 sites

  • Study site

    Pärnu

  • Study site

    Tallinn

  • Study site

    Tartu

Other trials in Estonia

France3 sites

  • Study site

    Bourges Cedex N/A

  • Study site

    Dole

  • Study site

    Romans-sur-Isère

Other trials in France

Spain3 sites

  • Study site

    Barcelona

  • Study site

    Madrid

  • Study site

    San Juan

Other trials in Spain

Bulgaria2 sites

  • Study site

    Plovdiv

  • Study site

    Varna

Other trials in Bulgaria

About this study

Official title: 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.

Read the 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.

Conditions
Schizophrenia
Being tested
RISPERDAL CONSTA, Paliperidone palmitate
Keywords
Schizophrenia, long-acting injectable antipsychotic medication
Medical subject headings
Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RISPERDAL CONSTADrug

    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.

  • Paliperidone palmitateDrug

    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.

Study groups in NCT00589914
Study groupRoleWhat they receive
RISPERDAL CONSTAActive comparatorRISPERDAL CONSTA 25-50 mg eq every 2 weeks
Receives: Drug: RISPERDAL CONSTA
R092670ExperimentalPaliperidone Palmitate 50-150 mg eq every 4 wks
Receives: Drug: Paliperidone palmitate

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change in the Positive and Negative Syndrome Scale (PANSS) Total Score for Schizophrenia

    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).

    Measured: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)

Secondary outcomes (2)

  1. The Change From Baseline for the CGI-S Score

    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.

    Measured: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)]

  2. The Change From Baseline in the PSP Score

    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.

    Measured: Baseline to the last postrandomization assessment in the double-blind treatment period (approximately 13 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Jan 2008 (estimated)
  2. Study startMar 2007
  3. Primary completionJun 2009
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
1,221 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00589914
Sponsor's protocol ID
CR012289
Other IDs
R092670PSY3006
Status last verified
Jun 2014
First submitted
21 Dec 2007
Last updated
24 Jun 2014
Data monitoring committee
No

Publications

  • Alphs L, Bossie CA, Fu DJ, Ma YW, Kern Sliwa J. Onset and persistence of efficacy by symptom domain with long-acting injectable paliperidone palmitate in patients with schizophrenia. Expert Opin Pharmacother. 2014 May;15(7):1029-42. doi: 10.1517/14656566.2014.909409.

    PubMed 24754314

  • Fu DJ, Bossie CA, Sliwa JK, Ma YW, Alphs L. Paliperidone palmitate versus oral risperidone and risperidone long-acting injection in patients with recently diagnosed schizophrenia: a tolerability and efficacy comparison. Int Clin Psychopharmacol. 2014 Jan;29(1):45-55. doi: 10.1097/YIC.0000000000000006.

    PubMed 24113628

  • Fu DJ, Bossie CA, Kern Sliwa J, Ma YW, Alphs L. Paliperidone palmitate versus risperidone long-acting injection in markedly-to-severely ill schizophrenia subjects: onset of efficacy with recommended initiation regimens. Clin Schizophr Relat Psychoses. 2014 Jul;8(2):101-9, 109A.

    PubMed 23446197

  • Pandina G, Lane R, Gopal S, Gassmann-Mayer C, Hough D, Remmerie B, Simpson G. A double-blind study of paliperidone palmitate and risperidone long-acting injectable in adults with schizophrenia. Prog Neuropsychopharmacol Biol Psychiatry. 2011 Jan 15;35(1):218-26. doi: 10.1016/j.pnpbp.2010.11.008. Epub 2010 Nov 16.

    PubMed 21092748

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RISPERDAL CONSTA and Paliperidone palmitate in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 82 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 82 sites in United States, Poland, Germany, Ukraine, Czechia and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Oct 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00589914, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2014.

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