SchizophreniaPhase 3NCT00083668
Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of 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 primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with 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
- 619 participants
- Where
- No sites listed yet
- Study dates
- Apr 2004to May 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
- Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
- experiencing an acute episode, with a total PANSS score at screening between 70 and 120
- agree to voluntary hospitalization for a minimum of 14 days
- willing and able to fill out self-administered questionnaires
- must be able to be compliant with self-administration of medication, or have consistent help/support available.
- Open-label phase: have completed the 6 weeks of double-blind treatment or completed at least 21 days of treatment and discontinued due to lack of efficacy
- patient and investigator must agree that open-label treatment is in the best interest of the patient.
Who cannot join
- Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
- history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of a lack of response (2 adequate trials) to any antipsychotic
- significant risk of suicidal or violent behavior. Open-label extension: patients believed by the investigator to be at significant risk for suicidal or violent behavior
- received an injection of a depot antipsychotic since entry into the preceding double-blind phase.
About this study
Official title: A Randomized, Double-blind, Placebo- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia
The primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia
Read the detailed description
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension. This study is designed to evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared with placebo in adult patients with schizophrenia. This is a multicenter, double-blind, randomized, placebo- and active-controlled, parallel-group, dose-response study. Patients will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3, 9, or 15 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes a screening period of up to 5 days, followed by a 6-week double-blind treatment phase. Following the double-blind treatment phase, eligible patients (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days) may enter the 52-week open-label extension with paliperidone ER monotherapy. While patients are hospitalized, efficacy will be assessed twice during the first week and at the end of the second week, and after patients are discharged from the hospital, they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind phase by completion of 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). The primary efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS total score. Safety will be monitored throughout the study and includes assessments of the incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests. Double-blind phase: 3, 9, 15 mg of paliperidone ER, 10 mg of olanzapine or placebo taken orally once a day for 6 weeks.
Open-label phase: start on paliperidone ER 9 mg orally once a day; maintained on a flexible oral dosage of paliperidone ER (3, 6, 9, 12, or 15 mg/day) for 52 weeks.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Paliperidone, Olanzapine, PANSS, Extended release, Atypical neuroleptic
- 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.
Change from baseline in the total PANSS score to the end of the double-blind phase.
Secondary outcomes (1)
Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and SQLS-R4.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2004 (estimated)
- Study startApr 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- 619 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
- NCT00083668
- Sponsor's protocol ID
- CR004375
- Status last verified
- Mar 2010
- First submitted
- 27 May 2004
- Last updated
- 8 Jun 2011
- Results posted
- No
Publications
Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007 Jul;93(1-3):117-30. doi: 10.1016/j.schres.2007.03.003. Epub 2007 Apr 26.
PubMed 17466492Meltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.
PubMed 18466043
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- and Active-controlled, Parallel-group, Dose-response Study to Evaluate the Efficacy and Safety of 3 Fixed Dosages of Paliperidone Extended Release (ER) Tablets and Olanzapine, With Open-label Extension, in the Treatment of Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00083668
- Acronym / sponsor ID
- CR004375
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Olanzapine, PANSS, Extended release, Atypical neuroleptic
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 619 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- Apr 2004
- Study completion
- May 2005 (actual)
- First posted
- 28 May 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 primary objective of the double-blind phase of this study is to evaluate the efficacy and safety of 3 fixed dosages of paliperidone ER (3, 9, and 15 mg/day) compared with placebo in adult patients with schizophrenia
Detailed description
Paliperidone is being developed as a new therapeutic agent for the treatment of schizophrenia. The extended-release (ER) formulation of paliperidone was developed to deliver paliperidone at a relatively constant rate over a 24-hour period to improve the tolerability profile and decrease the potential for orthostatic hypotension. This study is designed to evaluate the efficacy and safety and tolerability of 3 dosages of paliperidone ER compared with placebo in adult patients with schizophrenia. This is a multicenter, double-blind, randomized, placebo- and active-controlled, parallel-group, dose-response study. Patients will be randomized into 1 of 5 treatment groups to receive oral dosages of paliperidone ER 3, 9, or 15 mg, olanzapine 10 mg, or placebo once daily for a 6-week period. The study includes a screening period of up to 5 days, followed by a 6-week double-blind treatment phase. Following the double-blind treatment phase, eligible patients (those who have completed the 6-week double-blind phase or who discontinue due to lack of efficacy after a minimum of 21 days) may enter the 52-week open-label extension with paliperidone ER monotherapy. While patients are hospitalized, efficacy will be assessed twice during the first week and at the end of the second week, and after patients are discharged from the hospital, they will return to have efficacy and safety assessments performed on a weekly basis through the end of the 6-week double-blind phase. Efficacy will be evaluated throughout the 6-week double-blind phase by completion of 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). The primary efficacy response will be measured by the change from baseline score to end of double-blind phase for PANSS total score. Safety will be monitored throughout the study and includes assessments of the incidence of adverse events; measurement of extrapyramidal symptoms using 3 rating scales (Abnormal Involuntary Movement Scale [AIMS], Barnes Akathisia Rating Scale [BARS], Simpson-Angus Rating Scale [SAS]); measurement of vital signs (laying down and standing blood pressure, pulse, temperature); electrocardiograms; and clinical laboratory tests. Double-blind phase: 3, 9, 15 mg of paliperidone ER, 10 mg of olanzapine or placebo taken orally once a day for 6 weeks.
Open-label phase: start on paliperidone ER 9 mg orally once a day; maintained on a flexible oral dosage of paliperidone ER (3, 6, 9, 12, or 15 mg/day) for 52 weeks.
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 (7 listed)
- Double-blind phase: DSM-IV diagnosis of schizophrenia for at least 1 year
- experiencing an acute episode, with a total PANSS score at screening between 70 and 120
- agree to voluntary hospitalization for a minimum of 14 days
- willing and able to fill out self-administered questionnaires
- must be able to be compliant with self-administration of medication, or have consistent help/support available.
Key exclusion criteria (7 listed)
- Double-blind phase: DSM-IV axis I diagnosis other than schizophrenia
- DSM-IV diagnosis of substance dependence within 6 months prior to screening evaluation (nicotine and caffeine dependence are not exclusionary)
- history of tardive dyskinesia or neuroleptic malignant syndrome (NMS)
- history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic)
- previous history of a lack of response (2 adequate trials) to any antipsychotic
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
Change from baseline in the total PANSS score to the end of the double-blind phase.
1 secondary outcome
Changes from baseline to the end of the double-blind phase in PSP, CGI-S, and 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 8 Jun 2011.
- Results publication: PubMed 17466492Davidson M, Emsley R, Kramer M, Ford L, Pan G, Lim P, Eerdekens M. Efficacy, safety and early response of paliperidone extended-release tablets (paliperidone ER): results of a 6-week, randomized, placebo-controlled study. Schizophr Res. 2007 Jul;93(1-3):117-30. doi: 10.1016/j.schres.2007.03.003. Epub 2007 Apr 26.
- Results publication: PubMed 18466043Meltzer HY, Bobo WV, Nuamah IF, Lane R, Hough D, Kramer M, Eerdekens M. Efficacy and tolerability of oral paliperidone extended-release tablets in the treatment of acute schizophrenia: pooled data from three 6-week, placebo-controlled studies. J Clin Psychiatry. 2008 May;69(5):817-29. doi: 10.4088/jcp.v69n0515.
- Trial Evaluating Three Fixed Doses of Paliperidone Extended-Release (ER) Tablets and Olanzapine in the Treatment of Patients With SchizophreniaLink provided by the sponsor.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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 7 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?
Change from baseline in the total PANSS score to the end of the double-blind phase.. 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 NCT00083668, which also lists 2 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.