SchizophreniaPhase 4NCT00946985
28-30 Month Study Comparing Paliperidone Palmitate With Oral Risperidone for Treating Adults Diagnosed With Schizophrenia Within the Past 5 Years
A Phase 4 study testing paliperidone palmitate and oral risperidone in people with Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 72 sites in 12 countries.
Trial summary
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- paliperidone palmitate and oral risperidone
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 163 participants
- Where
- 72 sitesin 12 countries
- Study dates
- Jun 2009to Mar 2010
- Phase
- Phase 4
- 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 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate
- All patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Must have a current diagnosis of schizophrenia
- must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
- Women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
- Women of childbearing potential must have a negative urine pregnancy test at screening
- Patients must be cooperative and reliable, agree to receive regular injections, and be willing/able to adhere to the prohibitions and restrictions specified in this protocol.
Who cannot join
- Patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
- Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- Patients who are in their first episode of psychosis
- Patients currently meeting criteria for any other Axis I diagnosis except substance abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
- Meet the Diagnostic and Statistical Manual of Mental Health Disorders fourth edition (DSM-IV) definition of substance dependence (except for nicotine and caffeine dependence) within 6-months prior to entry
Show all 9Show fewer
- Patients with known allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to paliperidone palmitate, risperidone, Risperdal®, Risperdal® Consta®, or INVEGA® or its excipients
- Patients who received Long Acting Therapy (LAT) treatment within 2 injection cycles prior to screening
- Women who are pregnant or breast-feeding, or planning to become pregnant.
Trial locations and contacts
72 sites in 12 countries.
72 sites in 12 countries
United States23 sites
Study site
Arlington, Texas
Study site
Austin, Texas
Study site
Brooklyn, New York
Study site
Chicago, Illinois
Study site
Creve Coeur, Missouri
Study site
Flowood, Mississippi
Study site
Garden Grove, California
Study site
Hoffman Estates, Illinois
Study site
Irving, Texas
Study site
Kingsport, Indiana
Study site
Kissimmee, Florida
Study site
Lake Charles, Louisiana
Study site
Little Rock, Arkansas
Study site
Middleburg Heights, Ohio
Study site
Minneapolis, Minnesota
Study site
Omaha, Nebraska
Study site
Pittsfield, Massachusetts
Study site
Portsmount, Virginia
Study site
San Diego, California
Study site
Shreveport, Louisiana
Study site
St Louis, Missouri
Study site
Tampa, Florida
Study site
Washington D.C., District of Columbia
India9 sites
Study site
Ahmedabad
Study site
Aurangabad
Study site
Calicut
Study site
Hyderabad
Study site
Jaipur
Study site
Lucknow Gpo
Study site
Mangalore
Study site
Pune
Study site
Varanasi
China8 sites
Study site
Baoding
Study site
Beijing
Study site
Changsha
Study site
Guangzhou
Study site
Kunming
Study site
Shanghai
Study site
Wuhan
Study site
Xi'an
Canada5 sites
Study site
Calgary, Alberta
Study site
Greater Sudbury, Ontario
Study site
Halifax, Nova Scotia
Study site
Montreal, Quebec
Study site
Québec, Quebec
Russia5 sites
Study site
Moscow
Study site
Nizny Novgorod
Study site
Saint Petersburg
Study site
Samara
Study site
Yaroslavl
Ukraine5 sites
Study site
Kharkiv
Study site
Kherson
Study site
Kiev
Study site
Odesa
Study site
Simferopol
Czechia4 sites
Study site
Kutná Hora
Study site
Olomouc
Study site
Prague
Study site
Strakonice
South Korea4 sites
Study site
Gwangju
Study site
Gyeonggi-do
Study site
Jeonju
Study site
Seoul
About this study
Official title: A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
Read the detailed description
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.
- Conditions
- Schizophrenia
- Being tested
- paliperidone palmitate, oral risperidone
- Keywords
- Schizophrenia, Risperidone, Risperdal, Paliperidone Palmitate, Invega Sustenna
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone palmitateDrug
50, 75, 100, or 150 mg eq. monthly injection for 2 years
oral risperidoneDrug
2, 4, 6, or 8 mg tabs once daily for two years
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | paliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years Receives: Drug: paliperidone palmitate |
| 002 | Active comparator | oral risperidone 2 4 6 or 8 mg tabs once daily for two years Receives: Drug: oral risperidone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Relapse During Relapse Prevention Phase
Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2010
- Study completionMar 2010
Why it stopped: The recruitment rate for the study was inadequate to achieve its enrollment goals.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 163 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial, Study director, Ortho-McNeil Janssen Scientific Affairs, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00946985
- Sponsor's protocol ID
- CR015646
- Other IDs
- R092670SCH3004
- Status last verified
- Sep 2012
- First submitted
- 2 Jul 2009
- Last updated
- 10 Sep 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Active-controlled, Rater-blinded Study of the Prevention of Relapse Comparing Paliperidone Palmitate With Oral Risperidone in Adults With Recently-Diagnosed Schizophrenia Who Are at High Risk of Relapse
- ClinicalTrials.gov ID
- NCT00946985
- Acronym / sponsor ID
- CR015646
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Risperdal, Paliperidone Palmitate, Invega Sustenna
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The recruitment rate for the study was inadequate to achieve its enrollment goals.
- Enrolment
- 163 participants (actual)
- Lead sponsor
- Ortho-McNeil Janssen Scientific Affairs, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2009
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 27 Jul 2009 (estimated)
- Results
- Posted 16 Jul 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study will assess the use of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse.
Detailed description
This is a Prospective, Randomized, Active-controlled, Rater-blinded Study to to assess the efficacy of paliperidone palmitate compared with oral risperidone in delaying time to relapse in patients recently diagnosed with schizophrenia who are at high risk of relapse. Recently diagnosed is defined as first diagnosis of any psychotic disorder within 5 years prior to screening. High risk of relapse is defined as having documented occurrence of 3 periods of breakthrough symptoms that required a change in patient care per the investigator's judgment (e.g., increase in dose, addition of a new drug, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, psychiatric hospitalization, etc.) within the previous 24 months, including 1 such period within the previous 6 months. Safety evaluations will include Adverse Event (AE) reporting, hematology and clinical chemistry laboratory tests, vital signs, electrocardiogram (ECG), and evaluations of suicidality and sexual functioning. Patients will receive either paliperidone palmitate 50, 75, 100, or 150 mg eq. monthly by injection for two years or oral risperidone 2, 4, 6, or 8 mg tabs once daily for two years.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: paliperidone palmitatepaliperidone palmitate 50 75 100 or 150 mg eq. monthly injection for 2 years |
| 002 | Active comparator | Drug: oral risperidoneoral risperidone 2 4 6 or 8 mg tabs once daily for two years |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients must be, in the opinion of the investigator, able to understand the informed consent form approved by the Institutional Review Board (IRB) or Independent Ethics Committee (IEC), as appropriate
- All patients must sign the study informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- Must have a current diagnosis of schizophrenia
- must have had 3 periods of breakthrough symptoms that required a change in patient care as determined by the investigator (e.g. increase in dose, addition of a new drug, hospitalization, increase in the level of psychiatric care, notable increases in the frequency or intensity of patient contact required to maintain outpatient status, etc.) within the previous 24 months, including 1 such period within the previous 6 months
- Women must be postmenopausal, surgically sterile, or otherwise be incapable of pregnancy, abstinent, or if sexually active, be practicing a highly effective method of birth control before entry, and must agree to continue to use the same method of contraception throughout the study
Key exclusion criteria (9 listed)
- Patients who are unable to provide their own consent or are involuntarily committed to psychiatric hospitalization
- Have attempted suicide within 12 months before screening or are at imminent risk of suicide or violent behavior
- Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- Patients who are in their first episode of psychosis
- Patients currently meeting criteria for any other Axis I diagnosis except substance abuse or an Axis II diagnosis of Mental Retardation or Borderline Personality Disorder
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| paliperidone palmitate50, 75, 100, or 150 mg eq. monthly injection for 2 years | Drug | 001 |
| oral risperidone2, 4, 6, or 8 mg tabs once daily for two years | Drug | 002 |
Primary outcome
Time to Relapse During Relapse Prevention Phase
Time frame: 24 months
Time to relapse during the relapse prevention phase was the primary efficacy variable of the study. Each case of potential relapse event were to be reviewed in a blinded fasion by an independent Relapse Monitoring Board, comprised of experts in the diagnostic, clinical and therapeutic management of schizophrenia.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ortho-McNeil Janssen Scientific Affairs, LLC Clinical Trial study director
Ortho-McNeil Janssen Scientific Affairs, LLC
72 sites in 12 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing paliperidone palmitate and oral risperidone in people with Schizophrenia, run by Ortho-McNeil Janssen Scientific Affairs, LLC at 72 sites in 12 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 9 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: stopped early, as of the sponsor's last update on 10 Sep 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 72 sites in United States, India, China, Canada, Russia and 7 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 16 Jul 2012). 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 Relapse Prevention Phase (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2012.