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AzTrials

SchizophreniaPhase 3NCT00590577

Effectiveness and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Patients With Schizophrenia

A Phase 3 study testing Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq. and Paliperidone palmitate 100 mg eq. in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 66 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 primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq. and Paliperidone palmitate 100 mg eq.
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
652 participants
Where
66 sitesin 8 countries
Study dates
Mar 2007to Mar 2008
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

  • Met diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM IV) 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 at screening of between 70 and 120, inclusive and at baseline of between 60 and 120, inclusive
  • Body mass index (BMI)
  • i.e., [weight (kg)]/[height (m)]², of >17.0 kg/m2
  • Women must be postmenopausal for at least 2 years, surgically sterile, abstinent, or agree to practice an effective method of birth control if they are sexually active before entry and throughout the study. Effective methods of birth control include: prescription hormonal contraceptives, intrauterine device, double-barrier method, and male partner sterilization. Women of childbearing potential must have a negative urine pregnancy test at baseline, before receiving a dose of study drug
  • Is able and willing to meet or perform study requirements (e.g., answer self-administered questionnaires). If a patient is unable to read the questions, study personnel may read documents and the patient may then mark his or her choice
  • Patients in the US must be able to understand spoken English to permit adequate ratings by the blinded central rater

Who cannot join

  • Primary diagnosis other than schizophrenia
  • Patients who are unable to provide their own consent or who are currently involuntarily committed to psychiatric hospitalization
  • DSM-IV diagnosis of active substance dependence within 3 months before the screening evaluation (nicotine and caffeine dependence are not exclusionary)
  • History of treatment resistance as defined by failure to respond to 2 adequate studies of different antipsychotic medications
  • an adequate study is defined as a minimum of 4 weeks at the patient's maximum tolerated dose
  • Relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI>=40), or other systemic disease
Show all 20Show fewer
  • History of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
  • Biochemistry, hematology or urinalysis test results that are not within the laboratory's normal reference range and are deemed to be clinically significant by the investigator
  • History or evidence of clinically significant hepatic disease (including aspartate aminotransferase [AST] or alanine aminotransferase [ALT] >2 times the upper limit of normal) at screening
  • History of neuroleptic malignant syndrome
  • Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
  • History of life threatening allergic reaction to any drug
  • Known or suspected hypersensitivity or intolerance of risperidone, paliperidone, Intralipid (placebo) or any of their excipients (e.g., soybean oil, egg yolks, phospholipids, glycerol)
  • Exposure to an experimental drug, experimental biologic, or experimental medical device within 6 months before screening or prior randomization into this study
  • Enrollment in 2 or more clinical research studies in the previous year or one or more clinical research studies in the previous 6 months (non intervention, observational, and retrospective studies excluded)
  • History of any active malignancy within the previous 5 years, with the exception of excised basal cell carcinomas
  • A woman who is pregnant, breast-feeding, or planning to become pregnant during the study period
  • Employee of the investigator or study center, with direct involvement in the proposed study or other studies under the direction of that investigator or study center, as well as family members of the employees or the investigator
  • Treatment with any of the following disallowed therapies: an injectable antipsychotic within 1 injection cycle before screening, an injection of RISPERDAL CONSTA within 6 weeks of screening, electroconvulsive therapy within 60 days before screening, previous injection of paliperidone palmitate within the past 10 months before baseline, use of clozapine within 3 months before baseline, nonselective or irreversible monoamine oxidase inhibitor antidepressants within 30 days before screening: other antidepressants unless patient has been on a stable dose for at least 30 days before screening, mood stabilizers and beta-blockers must be washed out by the beginning of the study
  • History or presence of circumstances that may increase the risk of the occurrence of serious illness or death in association with the use of drugs that affect heart rhythm

Trial locations and contacts

66 sites in 8 countries.

66 sites in 8 countries

United States32 sites

  • Study site

    Anaheim, California

  • Study site

    Arlington, Virginia

  • Study site

    Atlanta, Georgia

  • Study site

    Austin, Texas

  • Study site

    Baltimore, Maryland

  • Study site

    Cedarhurst, New York

  • Study site

    Cerritos, California

  • Study site

    Charleston, South Carolina

  • Study site

    Cincinnati, Ohio

  • Study site

    Escondido, California

  • Study site

    Glendale, California

  • Study site

    Hoffman Estates, Illinois

  • Study site

    Houston, Texas

  • Study site

    Jacksonville, Florida

  • Study site

    Kingsport, Indiana

  • Study site

    Kissimmee, Florida

  • Study site

    La Palma, California

  • Study site

    Lake Charles, Louisiana

  • Study site

    Los Angeles, California

  • Study site

    Miami, Florida

  • Study site

    Moore, Oklahoma

  • Study site

    National City, California

  • Study site

    New York, New York

  • Study site

    North Miami, Florida

  • Study site

    Olean, New York

  • Study site

    Richmond, Virginia

  • Study site

    Rockville, Maryland

  • Study site

    San Antonio, Texas

  • Study site

    San Diego, California

  • Study site

    Santa Ana, California

  • Study site

    Shreveport, Louisiana

  • Study site

    Wichita, Kansas

Other trials in United States

Russia9 sites

  • Study site

    Kazan'

  • Study site

    Lipetsk

  • Study site

    Moscow Russia

  • Study site

    Nizny Novgorod

  • Study site

    Saint Petersburg

  • Study site

    Samara

  • Study site

    St-Petersburg Na

  • Study site

    St-Petresburg

  • Study site

    Yaroslavl

Other trials in Russia

Romania7 sites

  • Study site

    Brasov

  • Study site

    Bucharest

  • Study site

    Craiova

  • Study site

    Iași

  • Study site

    Oradea

  • Study site

    Sibiu

  • Study site

    Tg Mures

Other trials in Romania

Ukraine5 sites

  • Study site

    Dnipro

  • Study site

    Kharkiv

  • Study site

    Kiev

  • Study site

    Odesa

  • Study site

    Simferopol

Other trials in Ukraine

Malaysia4 sites

  • Study site

    Johor Bahru

  • Study site

    Kota Bharu

  • Study site

    Kuala Lumpur

  • Study site

    Perak

Other trials in Malaysia

Taiwan4 sites

  • Study site

    Changhua

  • Study site

    Hualien City

  • Study site

    Kaohsiung City

  • Study site

    Taipei

Other trials in Taiwan

South Korea3 sites

  • Study site

    Gwangju

  • Study site

    Inchun

  • Study site

    Seoul

Other trials in South Korea

Serbia2 sites

  • Study site

    Belgrade

  • Study site

    Kragujevac

Other trials in Serbia

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (25 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia

The primary objectives of this study are to evaluate the efficacy and safety of 3 fixed doses of paliperidone palmitate administered i.m. after an initial loading dose of 150 mg eq. in the deltoid muscle followed by either deltoid or gluteal injections for a total of 13 weeks of treatment as compared with placebo in patients with schizophrenia.

Read the detailed description

The primary hypothesis is that, after an initial 150 mg eq. loading dose in the deltoid muscle followed by either deltoid or gluteal injections in patients with schizophrenia, paliperidone palmitate (25, 100, or 150 mg eq.) is superior to placebo as measured by the change in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) total score over a 13-week period.This is a randomized, double blind, placebo-controlled, parallel group, multicenter, dose-response study of men and women who have a Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV) diagnosis of schizophrenia. The secondary objectives are to: Assess the benefits in personal and social functioning (key secondary endpoint) associated with the use of paliperidone palmitate compared with placebo, Assess the global improvement in severity of illness associated with the use of paliperidone palmitate compared with placebo, Assess the dose-response and exposure-response relationship of paliperidone palmitate The study includes a screening period of up to 7 days and a 13 week double-blind treatment period. The screening period includes washout of disallowed psychotropic medications. Subjects without source documentation of previous exposure to at least 2 doses of oral risperidone, or paliperidone ER, or one dose of i.m. RISPERDAL CONSTA, or paliperidone palmitate will be given 4 to 6 days of paliperidone ER 6 mg/day for tolerability testing. Patients who have source documentation of previous exposure to the above medications and are currently taking another antipsychotic regimen will continue their current treatment through Day -1. At the beginning of the double-blind treatment period, subjects will be randomly assigned in equal numbers to 1 of 4 treatment groups (an initial loading dose of 150 mg eq. of paliperidone palmitate given by deltoid injection followed by 3 fixed i.m. doses of paliperidone palmitate [25, 100, or 150 mg eq.] on Days 8, 36, and 64 or placebo given in the same manner). Note: The choice of the injection site (deltoid or gluteal) for all remaining injections after the initial loading dose will be at the discretion of the investigator. The entire study, including the screening period, will last approximately 14 weeks.Samples for pharmacokinetic (PK) evaluation will be collected at designated time points. Effectiveness and safety will be evaluated periodically throughout the study. A pharmacogenomic blood sample (10 mL) will be collected from patients who give separate written informed consent for this part of the study (where local regulations permit). This will allow for pharmacogenomic research, as necessary. Participation in pharmacogenomic research is optional. Approximately 105 to 115 mL of whole blood will be collected during the study. Patients randomly assigned to paliperidone palmitate will receive i.m. injections of paliperidone palmitate (150 mg eq. deltoid injection of paliperidone palmitate on Day 1, followed by 25, 100, or 150 mg eq. of paliperidone palmitate i.m. on Days 8, 36, and 64). Patients randomly assigned to placebo will receive a deltoid injection of placebo on Day 1 followed by placebo on Days 8, 36, and 64.

Conditions
Schizophrenia
Being tested
Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq., Placebo, Paliperidone palmitate 100 mg eq.
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.

  • Paliperidone palmitate 25 mg eq.Drug

    Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8, 36, 64

  • Paliperidone palmitate 150 mg eq.Drug

    Paliperidone palmitate 150 mg eq. i.m. Days 1, 8, 36, 64

  • PlaceboDrug

    Placebo i.m. Days 1, 8, 36, 64

  • Paliperidone palmitate 100 mg eq.Drug

    Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8, 36, 64

Study groups in NCT00590577
Study groupRoleWhat they receive
001ExperimentalPaliperidone palmitate 25 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 25 mg eq. i.m. Days 8 36 64
Receives: Drug: Paliperidone palmitate 25 mg eq.
002ExperimentalPaliperidone palmitate 100 mg eq. Paliperidone palmitate 150 mg eq. i.m. Day 1 and 100 mg eq. i.m. Days 8 36 64
Receives: Drug: Paliperidone palmitate 100 mg eq.
003ExperimentalPaliperidone palmitate 150 mg eq. Paliperidone palmitate 150 mg eq. i.m. Days 1 8 36 64
Receives: Drug: Paliperidone palmitate 150 mg eq.
004Placebo comparatorPlacebo Placebo i.m. Days 1 8 36 64
Receives: Drug: Placebo

What is being measured

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

  1. Change in Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment

    The PANSS measures the severity of psychotic symptoms of schizophrenia. Scores range from 30 to 210, where 30=best and 210=worst. The change in PANSS total score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.

    Measured: Baseline to 13 weeks or the last post-baseline assessment

Secondary outcomes (2)

  1. Change in Personal and Social Performance Scale (PSP) Score From Baseline to Week 13 or the Last Post-baseline Assessment.

    The PSP scale measures the degree of normal function of a subject in interpersonal relationships and social interactions. Scores range from 1 to 100, where 1 is worst and 100 is best. The average change in PSP score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.

    Measured: Baseline to 13 weeks or the last post-baseline assessment

  2. Change in Clinical Global Impression-Severity (CGI-S) Scores From Baseline to Week 13 or the Last Post-baseline Assessment

    The CGI-S rating scale was used to assess the severity of a subject's overall clinical condition. Scores range from 1 to 7, where 1=best and 7=worst. The change in CGI-S score for all eligible subjects was measured from the beginning of the study to Week 13 (i.e., the end of the double-blind treatment period) or, if the subject left the study early, from the beginning of the study to the last assessment after baseline.

    Measured: Baseline to 13 weeks or the last post-baseline assessment

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 completionMar 2008
  4. Study completionMar 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
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
652 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00590577
Sponsor's protocol ID
CR012550
Other IDs
R092670PSY3007
Status last verified
May 2014
First submitted
21 Dec 2007
Last updated
4 Jun 2014

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

  • Bossie CA, Sliwa JK, Ma YW, Fu DJ, Alphs L. Onset of efficacy and tolerability following the initiation dosing of long-acting paliperidone palmitate: post-hoc analyses of a randomized, double-blind clinical trial. BMC Psychiatry. 2011 May 10;11:79. doi: 10.1186/1471-244X-11-79.

    PubMed 21569242

  • Alphs L, Bossie CA, Sliwa JK, Ma YW, Turner N. Onset of efficacy with acute long-acting injectable paliperidone palmitate treatment in markedly to severely ill patients with schizophrenia: post hoc analysis of a randomized, double-blind clinical trial. Ann Gen Psychiatry. 2011 Apr 11;10(1):12. doi: 10.1186/1744-859X-10-12.

    PubMed 21481243

  • Pandina GJ, Lindenmayer JP, Lull J, Lim P, Gopal S, Herben V, Kusumakar V, Yuen E, Palumbo J. A randomized, placebo-controlled study to assess the efficacy and safety of 3 doses of paliperidone palmitate in adults with acutely exacerbated schizophrenia. J Clin Psychopharmacol. 2010 Jun;30(3):235-44. doi: 10.1097/JCP.0b013e3181dd3103.

    PubMed 20473057

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Paliperidone palmitate 25 mg eq., Paliperidone palmitate 150 mg eq. and Paliperidone palmitate 100 mg eq. in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C. at 66 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 7 inclusion and 20 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 4 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 66 sites in United States, Russia, Romania, Ukraine, Malaysia 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 5 Oct 2009). 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 Positive and Negative Syndrome Scale (PANSS) Total Score From Baseline to Week 13 or the Last Post-baseline Assessment (time frame: Baseline to 13 weeks or the last post-baseline assessment). 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 NCT00590577, 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 4 Jun 2014.

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