SchizophreniaPhase 3NCT00210548
A Study to Evaluate the Effectiveness and Safety of 3 Doses of Paliperidone Palmitate in Treating Subjects With Schizophrenia
A Phase 3 study testing paliperidone palmitate in people with Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia. 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
- How many people
- 366 participants
- Where
- No sites listed yet
- Study dates
- Apr 2005to Jun 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation
- a total PANSS score of 70 to 120 at screening and baseline (pre-treatment) evaluations
- a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of more than 17.0 kg/m²
Who cannot join
- A primary active DSM-IV Axis I diagnosis other than schizophrenia
- a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
- a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
- a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
- a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.
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 (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
The purpose of this study is to evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.
Read the detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. Efficacy and safety will be evaluated periodically throughout the study. Samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a Personal and Social Performance (PSP) Scale. Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36, and 64 of the double-blind treatment period of the study.
- Conditions
- Schizophrenia
- Being tested
- paliperidone palmitate
- Keywords
- schizophrenia, intramuscular injection, antipsychotic agents, dementia praecox, paliperidone palmitate, mental disorders, PANSS.
- Medical subject headings
- Schizophrenia, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone palmitateDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
Secondary outcomes (1)
The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests, and other measures of drug safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startApr 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 366 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
- NCT00210548
- Sponsor's protocol ID
- CR002353
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010 Sep;25(5):247-56. doi: 10.1097/YIC.0b013e32833948fa.
PubMed 20389255
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, Dose-Response Study to Evaluate the Efficacy and Safety of 3 Fixed Doses (50 mg eq., 100 mg eq., and 150 mg eq.) of Paliperidone Palmitate in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT00210548
- Acronym / sponsor ID
- CR002353
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, intramuscular injection, antipsychotic agents, dementia praecox, paliperidone palmitate, mental disorders, PANSS.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 366 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2005
- Study completion
- Jun 2006 (actual)
- First posted
- 21 Sep 2005 (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 evaluate the effectiveness and safety of 3 doses of paliperidone palmitate in treating subjects with schizophrenia.
Detailed description
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter, dose-response study of patients who have a Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV) diagnosis of schizophrenia. The duration of the study is approximately 14 weeks, including a screening period of 1 week and a 13-week double-blind treatment period. Efficacy and safety will be evaluated periodically throughout the study. Samples for pharmacokinetic evaluation will be collected at designated time points, and a blood sample will be collected at baseline (before the start of double-blind treatment) for an optional pharmacogenomics (genetics) analysis. The hypothesis is that the 3 fixed doses of paliperidone are each more efficacious than placebo in treating subjects with schizophrenia. The effectiveness is measured primarily by the change in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS), and secondarily, by the investigator's Clinical Global Impression of Severity (CGI-S) and by the investigator's evaluation of the patient on a Personal and Social Performance (PSP) Scale. Four injections of paliperidone palmitate 50, 100, or 150 milligrams equivalent administered in the gluteal muscle (buttocks). Injections will be given on Days 1, 8, 36, and 64 of the double-blind treatment period of the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- A DSM-IV diagnosis of schizophrenia (disorganized, catatonic, paranoid, residual, or undifferentiated type) for at least 1 year before the screening evaluation
- a total PANSS score of 70 to 120 at screening and baseline (pre-treatment) evaluations
- a body mass index (BMI [weight (kilograms)]/[height (meters)]²) of more than 17.0 kg/m²
Key exclusion criteria (5 listed)
- A primary active DSM-IV Axis I diagnosis other than schizophrenia
- a decrease of 25% or more in the total PANSS score between screening and baseline evaluations
- a DSM-IV diagnosis of active substance dependence within 3 months of screening evaluation
- a history of treatment resistance as defined by failure to respond to 2 adequate trials of different antipsychotic medications
- a woman who is pregnant, breast-feeding, or planning to become pregnant during the study period.
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 palmitate | Drug | – |
Primary outcome
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization assessment.
1 secondary outcome
The investigator's Clinical Global Impression of the Severity (CGI-S) of schizophrenia and rating of mental function on a Personal and Social Performance Scale (PSP). Evaluations of adverse events, laboratory tests, and other measures of drug safety.
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 20389255Gopal S, Hough DW, Xu H, Lull JM, Gassmann-Mayer C, Remmerie BM, Eerdekens MH, Brown DW. Efficacy and safety of paliperidone palmitate in adult patients with acutely symptomatic schizophrenia: a randomized, double-blind, placebo-controlled, dose-response study. Int Clin Psychopharmacol. 2010 Sep;25(5):247-56. doi: 10.1097/YIC.0b013e32833948fa.
- A study to evaluate the efficacy and safety of 3 doses of paliperidone palmitate in treating subjects with schizophreniaLink 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 palmitate 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 3 inclusion and 5 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?
The change in the total score of the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) from the beginning to the end of the double-blind treatment period or to the last post-randomization 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 NCT00210548, which also lists 1 linked publication.
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; AzTrials last refreshed its copy on 6 Nov 2026.