SchizophreniaPhase 3NCT00086320
A Study of Effectiveness and Safety of Paliperidone Extended-release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of 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 ER
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- Mar 2004to Aug 2005
- 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
- DSM-IV diagnosis of schizophrenia at least 1 year before screening
- experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
- agree to be hospitalized for a minimum of 14 days at the start of the study
- capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
- resided at the same address continuously for at least 30 days prior to screening
- able and willing to fill out self administered questionnaires
- washout of antiparkinsonian medications, beta-blockers
- antiepileptics, lithium 3 days prior to the start of the run-in phase
Who cannot join
- DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- previous history of lack of response to risperidone when acutely psychotic
- history of neuroleptic malignant syndrome
- significant risk of suicidal or violent behavior
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.
Read the detailed description
Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment. This trial is designed to evaluate efficacy and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients with schizophrenia. This trial 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 consisting of 5 phases: a screening phase of up to 5 days; a 8-week open-label run-in phase, during which all patients will be treated with open-label, flexibly dosed paliperidone ER (3 to 15 mg) orally once daily to identify a dose that will achieve control of their acute psychotic symptoms (only patients who maintain a stable dosage regimen and have a total Positive and Negative Syndrome Scale [PANSS] score </=70; Clinical Global Impression Scale - Severity [CGI-S] </=4; and scores of </=4 for PANSS items for delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, hostility, and uncooperativeness during the last 2 weeks of the run-in phase will be eligible to continue in the stabilization phase); a 6-week open-label stabilization phase, patients who maintain control of their acute psychotic symptoms at the paliperidone ER dosage identified during the run-in phase and meet the total PANSS score, CGI-S, and PANSS items scores throughout the stabilization phase will be randomized to receive either flexibly dosed paliperidone ER, starting at the dose maintained during the stabilization phase of the study, or placebo; a double-blind treatment phase of variable duration, during which patients will be followed until they meet either defined criteria for recurrence or the study ends; a 52-week open-label extension phase for patients who experience a recurrence event during the double-blind phase of the study, or who remain recurrence free for the entire double-blind phase of the study. Efficacy will be assessed using the PANSS and CGI-S scores that will be collected every week, every 2 weeks, or every 4 weeks throughout. Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (orthostatic pulse rate, orthostatic blood pressure, and temperature); and clinical laboratory tests. In the run-in, double-blind, and open-label extension phases of the study, paliperidone ER or matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day (3, 6, 9, 12, or 15 mg/day). The dosage in the stabilization phase will be fixed throughout at the dosage that achieved symptom control in the run-in phase.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, paliperidone, Risperidone
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
Secondary outcomes (1)
Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2004 (estimated)
- Study startMar 2004
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00086320
- Sponsor's protocol ID
- CR004384
- Status last verified
- Apr 2010
- First submitted
- 30 Jun 2004
- Last updated
- 8 Jun 2011
- Results posted
- No
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 32606705Weiden 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 28640988Kramer M, Simpson G, Maciulis V, Kushner S, Vijapurkar U, Lim P, Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007 Feb;27(1):6-14. doi: 10.1097/JCP.0b013e31802dda4a.
PubMed 17224706
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-controlled, Parallel-group Study With an Open-label Extension Evaluating Paliperidone Extended Release Tablets in the Prevention of Recurrence in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT00086320
- Acronym / sponsor ID
- CR004384
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, paliperidone, Risperidone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Mar 2004
- Study completion
- Aug 2005 (actual)
- First posted
- 1 Jul 2004 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the efficacy (effectiveness) and safety of paliperidone ER compared with placebo in the prevention of recurrence of symptoms of schizophrenia.
Detailed description
Paliperidone ER is currently being investigated as treatment for the acute symptoms of schizophrenia and also as maintenance treatment. This trial is designed to evaluate efficacy and safety of paliperidone ER in prevention of recurrence of psychotic symptoms in patients with schizophrenia. This trial 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 consisting of 5 phases: a screening phase of up to 5 days; a 8-week open-label run-in phase, during which all patients will be treated with open-label, flexibly dosed paliperidone ER (3 to 15 mg) orally once daily to identify a dose that will achieve control of their acute psychotic symptoms (only patients who maintain a stable dosage regimen and have a total Positive and Negative Syndrome Scale [PANSS] score </=70; Clinical Global Impression Scale - Severity [CGI-S] </=4; and scores of </=4 for PANSS items for delusions, conceptual disorganization, hallucinatory behavior, suspiciousness/persecution, hostility, and uncooperativeness during the last 2 weeks of the run-in phase will be eligible to continue in the stabilization phase); a 6-week open-label stabilization phase, patients who maintain control of their acute psychotic symptoms at the paliperidone ER dosage identified during the run-in phase and meet the total PANSS score, CGI-S, and PANSS items scores throughout the stabilization phase will be randomized to receive either flexibly dosed paliperidone ER, starting at the dose maintained during the stabilization phase of the study, or placebo; a double-blind treatment phase of variable duration, during which patients will be followed until they meet either defined criteria for recurrence or the study ends; a 52-week open-label extension phase for patients who experience a recurrence event during the double-blind phase of the study, or who remain recurrence free for the entire double-blind phase of the study. Efficacy will be assessed using the PANSS and CGI-S scores that will be collected every week, every 2 weeks, or every 4 weeks throughout. Safety assessments include the incidence of adverse events throughout the study; measurement of vital signs (orthostatic pulse rate, orthostatic blood pressure, and temperature); and clinical laboratory tests. In the run-in, double-blind, and open-label extension phases of the study, paliperidone ER or matching placebo will be flexibly dosed in the range 3 to 15 mg orally once a day (3, 6, 9, 12, or 15 mg/day). The dosage in the stabilization phase will be fixed throughout at the dosage that achieved symptom control in the run-in phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- DSM-IV diagnosis of schizophrenia at least 1 year before screening
- experiencing an acute schizophrenic episode with a total PANSS score between 70 and 120
- agree to be hospitalized for a minimum of 14 days at the start of the study
- capable of administering study medication themselves or have assistance with study medication administration consistently available throughout the study
- resided at the same address continuously for at least 30 days prior to screening
Key exclusion criteria (7 listed)
- DSM-IV Axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening (nicotine and caffeine dependence are not exclusionary)
- preexisting severe gastrointestinal narrowing (pathologic or iatrogenic)
- injection of a depot antipsychotic within 120 days before screening, or use of paliperidone palmitate within 10 months before screening
- previous history of lack of response to risperidone when acutely psychotic
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 ER | Drug | – |
Primary outcome
Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.
1 secondary outcome
Change in PANSS total and subscale scores from randomization to each visit and to the end of the study. Change from baseline in CGI-S at each assessment time point and at endpoint. Incidence of adverse events throughout study.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2011.
- Derived from this study: PubMed 32606705Mathews 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.
- Derived from this study: PubMed 28640988Weiden 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.
- Derived from this study: PubMed 17224706Kramer M, Simpson G, Maciulis V, Kushner S, Vijapurkar U, Lim P, Eerdekens M. Paliperidone extended-release tablets for prevention of symptom recurrence in patients with schizophrenia: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol. 2007 Feb;27(1):6-14. doi: 10.1097/JCP.0b013e31802dda4a.
- A Study of Effectiveness and Safety of Paliperidone Extended-Release (ER) Tablets in the Prevention of Recurrence in Adult Patients With Schizophrenia.Link provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research & Development, L.L. C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 8 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 8 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
Time to recurrence, defined as the time between randomization to treatment in the double-blind period and the first documentation of a recurrence.. 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 NCT00086320, which also lists 3 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 8 Jun 2011.