SchizophreniaPhase 3NCT00210769
A Study of the Long-term Safety and Tolerability and the Long-term Effectiveness of Extended-release Oral Paliperidone in Patients Diagnosed With Schizophrenia
A Phase 3 study testing paliperidone ER Oros 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 long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed 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 ER Oros
- How many people
- 203 participants
- Where
- No sites listed yet
- Study dates
- Jan 2004to Dec 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
- completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
- for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.
Who cannot join
- As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
- a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
- considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
- received an injection of a depot antipsychotic since entry into the double-blind study
- a woman who has become pregnant.
About this study
Official title: Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia
The purpose of this study is to evaluate the long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.
Read the detailed description
The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with schizophrenia, by avoiding peaks and troughs of drug levels in the blood. This could in turn provide an improved quality of life and overall functioning for patients.
This open-label study is an extension of a 6-week randomized, double-blind, parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia: paliperidone 6 or 12 milligrams (mg), olanzapine 10 mg (an approved treatment for schizophrenia), or placebo. Following the double-blind treatment phase, eligible patients may enter this 52-week open-label extension with slow, extended-release paliperidone (with no comparison treatments). In the open-label extension, all patients, regardless of their randomized treatment in the double-blind phase, will begin on extended-release paliperidone 9 mg once daily. Thereafter, patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study. The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator, based on observations of patient response and tolerability. Because flexible dosing more closely mimics clinical practice, this design may provide more clinically relevant findings in the open-label setting.The final visit in the double-blind phase may serve as the initial visit for the open-label extension. Study visits will occur at Day 4 and then weekly for the first 4 weeks (Weeks 1, 2, 3, and 4) and then every 4 weeks through Week 52 or until early termination. Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension. Flexible dosage (3, 6, 9, or 12 milligrams (mg)) extended-release paliperidone tablets administered orally once daily for 52 weeks, following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg.
- Conditions
- Schizophrenia
- Being tested
- paliperidone ER Oros
- Keywords
- schizophrenia, extended release, oral administration, antipsychotic agents, dementia praecox, mental disorders, paliperidone, 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 ER OrosDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.
Secondary outcomes (1)
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).
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 startJan 2004
- Study completionDec 2005
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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 203 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
- NCT00210769
- Sponsor's protocol ID
- CR004426
- Status last verified
- Apr 2010
- First submitted
- 13 Sep 2005
- Last updated
- 18 May 2011
- Results posted
- No
Publications
Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.
PubMed 21155708
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-label Extension of A Randomized, Double-Blind, Placebo- and Active-Controlled, Parallel-Group, Dose-Response Study to Evaluate the Efficacy and Safety of 2 Fixed Dosages of Extended Release OROS� Paliperidone (6 and 12 mg/Day) and Olanzapine (10 mg/Day), in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00210769
- Acronym / sponsor ID
- CR004426
- Conditions
- Schizophrenia
- Keywords
- schizophrenia, extended release, oral administration, antipsychotic agents, dementia praecox, mental disorders, paliperidone, PANSS
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 203 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Jan 2004
- Study completion
- Dec 2005 (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 long-term safety and tolerability and the maintenance of effectiveness of a slow, extended-release oral formulation of paliperidone administered once daily to patients diagnosed with schizophrenia.
Detailed description
The controlled rate of drug delivery provided by the extended-release oral formulation of paliperidone may provide improved effectiveness and a reduced risk of certain adverse effects in patients with schizophrenia, by avoiding peaks and troughs of drug levels in the blood. This could in turn provide an improved quality of life and overall functioning for patients.
This open-label study is an extension of a 6-week randomized, double-blind, parallel-group study in which the effectiveness and safety of 4 different oral treatments administered once daily are compared in patients with schizophrenia: paliperidone 6 or 12 milligrams (mg), olanzapine 10 mg (an approved treatment for schizophrenia), or placebo. Following the double-blind treatment phase, eligible patients may enter this 52-week open-label extension with slow, extended-release paliperidone (with no comparison treatments). In the open-label extension, all patients, regardless of their randomized treatment in the double-blind phase, will begin on extended-release paliperidone 9 mg once daily. Thereafter, patients will be maintained on a flexible dosage of extended-release paliperidone throughout the 52-week study. The dosage may be increased or decreased within this range in accordance with the clinical judgment of the investigator, based on observations of patient response and tolerability. Because flexible dosing more closely mimics clinical practice, this design may provide more clinically relevant findings in the open-label setting.The final visit in the double-blind phase may serve as the initial visit for the open-label extension. Study visits will occur at Day 4 and then weekly for the first 4 weeks (Weeks 1, 2, 3, and 4) and then every 4 weeks through Week 52 or until early termination. Evaluations of the safety and effectiveness of extended-release paliperidone treatment will be performed at scheduled times throughout the open-label extension. Flexible dosage (3, 6, 9, or 12 milligrams (mg)) extended-release paliperidone tablets administered orally once daily for 52 weeks, following a 6-week double-blind study in which patients receive fixed oral doses of 6 mg or 12 mg extended-release paliperidone or olanzapine 10 mg.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- As for the double-blind study, a diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM IV)
- experiencing an acute episode of schizophrenia at time of screening for the double-blind study, with a total PANSS score of 70 to 120
- completed the double-blind study or discontinued after at least 21 days of double-blind treatment because of lack of efficacy
- for female patients of childbearing potential, agreement to continue to use an acceptable form of contraception throughout the open-label extension, with a negative urine pregnancy test at open-label baseline.
Key exclusion criteria (5 listed)
- As for the double-blind study, a DSM-IV axis I diagnosis other than schizophrenia
- a DSM-IV diagnosis of substance dependence within 6 months prior to screening for the double-blind study
- considered by the investigator to be at significant risk for suicidal or violent behavior during the open-label study
- received an injection of a depot antipsychotic since entry into the double-blind study
- a woman who has become pregnant.
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 Oros | Drug | – |
Primary outcome
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.
1 secondary outcome
Assessment of long-term effectiveness by the Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression Scale - Severity (CGI-S), Personal and Social Performance Scale (PSP), and Schizophrenia Quality of Life Scale, Revision 4 (SQLS-R4).
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 18 May 2011.
- Derived from this study: PubMed 21155708Kozma C, Dirani R, Canuso C, Mao L. Change in employment status over 52 weeks in patients with schizophrenia: an observational study. Curr Med Res Opin. 2011 Feb;27(2):327-33. doi: 10.1185/03007995.2010.541431. Epub 2010 Dec 15.
- A study of the long-term safety and tolerability and the long-term effectiveness of extended-release oral paliperidone in patients diagnosed 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 Oros 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 4 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 18 May 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?
Standard safety evaluations, and monitoring of extrapyramidal symptoms (tardive dyskinesia, akathisia) by the Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS), throughout the long-term study.. 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 NCT00210769, 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 18 May 2011.