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SchizophreniaPhase 3NCT00111189

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

A Phase 3 study testing Paliperidone Palmitate in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 55 sites in 9 countries.

Completed

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

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone Palmitate
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
414 participants
Where
55 sitesin 9 countries
Study dates
Feb 2005to Feb 2008
Phase
Phase 3
Are there results?
None posted in the registry

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 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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.

Trial locations and contacts

55 sites in 9 countries.

55 sites in 9 countries

United States18 sites

  • Study site

    Cedarhurst, New York

  • Study site

    Cerritos, California

  • Study site

    Chicago, Illinois

  • Study site

    Clementon, New Jersey

  • Study site

    Cleveland, Ohio

  • Study site

    Conroe, Texas

  • Study site

    DeSoto, Texas

  • Study site

    Flowood, Mississippi

  • Study site

    Granite City, Illinois

  • Study site

    Hialeah, Florida

  • Study site

    Irving, Texas

  • Study site

    Lake Charles, Louisiana

  • Study site

    Little Rock, Arkansas

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    San Antonio, Texas

  • Study site

    Santa Ana, California

  • Study site

    Shreveport, Louisiana

  • Study site

    St Louis, Missouri

Other trials in United States

Ukraine9 sites

  • Study site

    Dnipro

  • Study site

    Hlevakha

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Kyiv

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Simferopol

  • Study site

    Vinnitsa

Other trials in Ukraine

Romania6 sites

  • Study site

    Bucharest

  • Study site

    Cluj-Napoca

  • Study site

    Iași

  • Study site

    Sibiu

  • Study site

    Tg Mures

  • Study site

    Timișoara

Other trials in Romania

Russia6 sites

  • Study site

    Arkhangelsk

  • Study site

    Moscow

  • Study site

    Moscow Russia

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    Yaroslavl

Other trials in Russia

South Africa4 sites

  • Study site

    Cape Town

  • Study site

    Centurion Gauteng

  • Study site

    Florida Johannesburg Gauteng

  • Study site

    Johannesburg

Other trials in South Africa

South Korea4 sites

  • Study site

    Gwangju

  • Study site

    Inchun

  • Study site

    Pusan

  • Study site

    Seoul

Other trials in South Korea

Taiwan4 sites

  • Study site

    Changhua

  • Study site

    Kaohsiung City

  • Study site

    Tainan

  • Study site

    Taoyuan

Other trials in Taiwan

Mexico3 sites

  • Study site

    Mérida

  • Study site

    Mexico City

  • Study site

    Monterrey

Other trials in Mexico

Costa Rica1 site

  • Study site

    Costa Rica

Other trials in Costa Rica

About this study

Official title: A Randomized Double-blind Placebo-controlled Parallel Group Study Evaluating Paliperidone Palmitate in the Prevention of Recurrence in Patients With Schizophrenia. Placebo Consists of 20% Intralipid (200 mg/mL) Injectable Emulsion.

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.

Read the 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
Being tested
Placebo, Paliperidone Palmitate
Keywords
Schizophrenia, Paliperidone palmitate, R092670, antipsychotic, recurrence prevention
Medical subject headings
Schizophrenia

What participants receive

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

  • PlaceboDrug

    Placebo every 4 wk up to 24 mo

  • Paliperidone PalmitateDrug

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

Study groups in NCT00111189
Study groupRoleWhat they receive
001ExperimentalPaliperidone Palmitate 25, 50, 75 or 100 mg eq every 4 wk for up to 24 mo
Receives: Drug: Paliperidone Palmitate
002Placebo comparatorPlacebo Placebo every 4 wk up to 24 mo
Receives: Drug: Placebo

What is being measured

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

  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

    Measured: After 68 relapse events

Secondary outcomes (1)

  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.

    Measured: After 68 relapse events

Timeline

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

  1. First posted18 May 2005 (estimated)
  2. Study startFeb 2005
  3. Primary completionFeb 2007
  4. Study completionFeb 2008

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
414 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00111189
Sponsor's protocol ID
CR004198
Other IDs
R092670PSY3001
Status last verified
Jun 2014
First submitted
17 May 2005
Last updated
20 Jun 2014
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 32840872

  • 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.

    PubMed 32606705

  • 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.

    PubMed 29924507

  • 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.

    PubMed 28640988

  • 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.

    PubMed 21696265

  • 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.

    PubMed 19959339

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paliperidone Palmitate in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 55 sites in 9 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 11 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 20 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 55 sites in United States, Ukraine, Romania, Russia, South Africa and 4 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. Some participants in this study may receive a placebo. 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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

The primary efficacy criteria for this study is the time from randomization to the first recurrence event during the double-blind recurrence prevention period (time frame: After 68 relapse events). 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 NCT00111189, which also lists 6 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 20 Jun 2014.

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