AzTrials
AzTrials

SchizophreniaPhase 3NCT01529515

A Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Patients With Schizophrenia

A Phase 3 study testing PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 53 sites in 8 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 evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Schizophrenia
What is being tested?
PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq.
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
509 participants
Where
53 sitesin 8 countries
Study dates
May 2012to Apr 2014
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 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients with schizophrenia for more than 1 year
  • A total score in the Positive and Negative Syndrome Scale (PANSS) < 120
  • Signed informed consent
  • Women must not be pregnant, breastfeeding, and if capable of pregnancy must practice an effective method of birth control
  • Men must agree to use a double-barrier method of birth control
  • Be medically stable on the basis of clinical laboratory tests, physical examination, medical history, vital signs, and electrocardiogram (ECG) Exclusion Criteria:
Show all 13Show fewer
  • A diagnosis other than schizophrenia, e.g., dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, primary substance-induced psychotic disorder, dementia-related psychosis
  • Relevant history or current presence of any significant or unstable medical condition(s) determined to be clinically significant by the Investigator (ie, obesity, diabetes, heart disease etc)
  • A diagnosis of substance dependence within 6 months before screening
  • History of neuroleptic malignant syndrome (NMS) or tardive dyskinesia
  • Clozapine use in the last 2 months when used for treatment-resistant or treatment-refractory illness
  • Clinically significant findings in biochemistry, hematology, ECG or urinalysis results
  • Any other disease or condition that, in the opinion of the investigator, would make participation not in the best interest of the patient or that could prevent, limit, or confound the protocol-specified assessments

Who cannot join

None listed.

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

United States15 sites

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Cedarhurst, New York

  • Study site

    Chicago, Illinois

  • Study site

    Dallas, Texas

  • Study site

    Flowood, Mississippi

  • Study site

    Hoffman Estates, Illinois

  • Study site

    Lauderhill, Florida

  • Study site

    Little Rock, Arkansas

  • Study site

    Marlton, New Jersey

  • Study site

    Oklahoma City, Oklahoma

  • Study site

    Salt Lake City, Utah

  • Study site

    San Fran Cisco, California

  • Study site

    Topeka, Kansas

  • Study site

    Washington D.C., District of Columbia

Other trials in United States

Ukraine15 sites

  • Study site

    Donetsk

  • Study site

    Evpatoriya

  • Study site

    Hlevakha

  • Study site

    Ivano-Frankivsk

  • Study site

    Kerch

  • Study site

    Kharkiv

  • Study site

    Kherson

  • Study site

    Kiev

  • Study site

    Lviv

  • Study site

    Odesa

  • Study site

    Poltava

  • Study site

    Smila

  • Study site

    Ternopil

  • Study site

    Uzhhorod

  • Study site

    Vinnitsa

Other trials in Ukraine

Mexico5 sites

  • Study site

    Guadajalara

  • Study site

    Mexico City

  • Study site

    Monterrey

  • Study site

    San Luis Potosí City

  • Study site

    Zapopan

Other trials in Mexico

Romania5 sites

  • Study site

    Arad

  • Study site

    Craiova

  • Study site

    Iași

  • Study site

    Sibiu

  • Study site

    Tg Mures

Other trials in Romania

Colombia4 sites

  • Study site

    Barranquilla

  • Study site

    Bogotá

  • Study site

    Medellín

  • Study site

    Pereira

Other trials in Colombia

South Korea4 sites

  • Study site

    Deajun

  • Study site

    Gyeongsangnam-Do

  • Study site

    Incheon

  • Study site

    Seongnam

Other trials in South Korea

Malaysia3 sites

  • Study site

    Johor Bahru

  • Study site

    Kuala Lumpur

  • Study site

    Tanjong Rambutan

Other trials in Malaysia

Turkey (Türkiye)2 sites

  • Study site

    Diyarbakır

  • Study site

    Sakarya

Other trials in Turkey (Türkiye)

About this study

Official title: A Randomized, Multicenter, Double-Blind, Relapse Prevention Study of Paliperidone Palmitate 3 Month Formulation for the Treatment of Subjects With Schizophrenia

The purpose of this study is to evaluate the efficacy of paliperidone palmitate 3 month formulation (PP3M) compared with placebo in delay of the time to first occurrence of relapse of the symptoms of schizophrenia.

Read the detailed description

This is a randomized (the study drug is assigned by chance), double blind (neither physician nor patient knows the treatment that the patient receives), parallel group (each group of patients will be treated at the same time), placebo-controlled (an inactive substance is compared with a drug to test whether the drug has a real effect in a clinical trial) multicenter study. The study consists of 4 phases: a Screening Phase (up to 3 weeks); a 17-week flexible dose open-label Transition Phase (open-label phase means that all people know the identity of the intervention); a 12-week fixed dose open-label Maintenance Phase; and a randomized, double-blind, fixed dose, placebo-controlled relapse prevention phase (referred to as the Double-blind Phase). Patients who meet specific stabilization criteria will enter the Double-blind Phase at Week 29. Patients will be randomly assigned, in a 1:1 ratio, to receive either a fixed dose of PP3M or placebo. The Double-blind Phase will be of variable duration; patients will remain in the study until they experience a relapse event or meet discontinuation criteria.

Conditions
Schizophrenia
Being tested
PP3M 175 mg eq., PP3M 263 mg eq., PP3M 350 mg eq., PP3M 525 mg eq., Placebo (20% Intralipid emulsion)
Keywords
Schizophrenia, R092670, Paliperidone Palmitate, Paliperidone palmitate 3 month formulation (PP3M)
Medical subject headings
Schizophrenia

What participants receive

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

  • PP3M 175 mg eq.Drug

    Type= exact number, unit= mg eq., number= 175, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

  • PP3M 263 mg eq.Drug

    Type= exact number, unit= mg eq., number= 263, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

  • PP3M 350 mg eq.Drug

    Type= exact number, unit= mg eq., number= 350, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

  • PP3M 525 mg eq.Drug

    Type= exact number, unit= mg eq., number= 525, form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

  • Placebo (20% Intralipid emulsion)Drug

    Form= injection, route= intramuscular use. One injection every three months up to the patient has a relapse event or meet discontinuation criteria.

Study groups in NCT01529515
Study groupRoleWhat they receive
Paliperidone palmitate 3-month (PP3M)ExperimentalNot described
Receives: Drug: PP3M 175 mg eq.; Drug: PP3M 263 mg eq.; Drug: PP3M 350 mg eq.; Drug: PP3M 525 mg eq.
PlaceboPlacebo comparatorNot described
Receives: Drug: Placebo (20% Intralipid emulsion)

What is being measured

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

  1. Time to Relapse During the Double-Blind Phase

    Time to relapse defined as the time between participant randomization into the double blind Phase and the first documentation of a relapse event. Median time to relapse was estimated by the Kaplan-Meier method.

    Measured: Approximately Week 60

Secondary outcomes (3)

  1. Change in Positive and Negative Syndrome Scale (PANSS) (Total Score) From Baseline to Endpoint in the Double-Blind Phase

    The PANSS 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 is rated 1 (absent) to 7 (extreme). The total score ranging from 30 to 210. Higher scores indicate more severe neuropsychiatric symptoms of schizophrenia.

    Measured: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)

  2. Change in Clinical Global Impression Severity (CGI-S) Scale From Baseline to Endpoint in the Double-Blind Phase

    The CGI-S rating scale is used to rate the severity of a participant's overall clinical condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe).

    Measured: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)

  3. Change in Personal and Social Performance (PSP) Scale From Baseline to Endpoint in the Double-Blind Phase

    The PSP scale measures personal and social functioning in the domains of: a) Socially useful activities, b) Personal and social relationships, c) Self-care, and d) Disturbing and aggressive behavior. The results of the assessment were converted to a numerical score which ranges from 1 to 100. A score lying between 71 and 100 indicates a mild degree of dysfunction; scores between 31 and 70 indicate varying degrees of difficulty, and a participant with a score of <=30 had functioning so poor that he or she required intensive supervision.

    Measured: Baseline (Day 1 prior to randomization) and Endpoint (Approximately Week 60)

Timeline

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

  1. First posted9 Feb 2012 (estimated)
  2. Study startMay 2012
  3. Primary completionApr 2014
  4. Study completionApr 2014

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
Double blind
Who is masked
Participant, Investigator
Enrolment
509 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01529515
Sponsor's protocol ID
CR100717
Other IDs
R092670PSY3012, 2011-004676-11, U1111-1135-1969
Status last verified
May 2016
First submitted
6 Feb 2012
Last updated
11 May 2016
Data monitoring committee
Yes

Publications

  • 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

  • Savitz AJ, Xu H, Gopal S, Nuamah I, Mathews M, Soares B. Efficacy and safety of paliperidone palmitate 3-month formulation in Latin American patients with schizophrenia: A subgroup analysis of data from two large phase 3 randomized, double-blind studies. Braz J Psychiatry. 2019 Nov-Dec;41(6):499-510. doi: 10.1590/1516-4446-2018-0153.

    PubMed 30994855

  • 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

  • Magnusson MO, Samtani MN, Plan EL, Jonsson EN, Rossenu S, Vermeulen A, Russu A. Population Pharmacokinetics of a Novel Once-Every 3 Months Intramuscular Formulation of Paliperidone Palmitate in Patients with Schizophrenia. Clin Pharmacokinet. 2017 Apr;56(4):421-433. doi: 10.1007/s40262-016-0459-3.

    PubMed 27743205

  • Gopal S, Vermeulen A, Nandy P, Ravenstijn P, Nuamah I, Buron Vidal JA, Berwaerts J, Savitz A, Hough D, Samtani MN. Practical guidance for dosing and switching from paliperidone palmitate 1 monthly to 3 monthly formulation in schizophrenia. Curr Med Res Opin. 2015 Nov;31(11):2043-54. doi: 10.1185/03007995.2015.1085849. Epub 2015 Oct 2.

    PubMed 26306819

  • Berwaerts J, Liu Y, Gopal S, Nuamah I, Xu H, Savitz A, Coppola D, Schotte A, Remmerie B, Maruta N, Hough DW. Efficacy and Safety of the 3-Month Formulation of Paliperidone Palmitate vs Placebo for Relapse Prevention of Schizophrenia: A Randomized Clinical Trial. JAMA Psychiatry. 2015 Aug;72(8):830-9. doi: 10.1001/jamapsychiatry.2015.0241.

    PubMed 25820612

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing PP3M 175 mg eq., PP3M 263 mg eq. and PP3M 350 mg eq. in people with Schizophrenia, run by Janssen Research & Development, LLC at 53 sites in 8 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 13 inclusion and 0 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 11 May 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, Ukraine, Mexico, Romania, Colombia and 3 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?

Yes. Results are posted in the registry (first posted 18 Jun 2015). 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?

Time to Relapse During the Double-Blind Phase (time frame: Approximately Week 60). 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 NCT01529515, 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 11 May 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in