SchizophreniaPhase 3NCT00334126
Evaluation of Effectiveness and Safety of Paliperidone ER (Extended-release) Compared With Quetiapine in Patients With Schizophrenia
A Phase 3 study of Schizophrenia, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 399 participants
- Where
- No sites listed yet
- Study dates
- Apr 2006to Sep 2007
- 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
- Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)
- score of >=4 on at least two of a subset of selected PANSS items and a total score on these five items of >=17
- score of >=5 on the CGI-S (clinical global impression - severity)
- body weight of at least 60kg and willing to be hospitalized for 9 days initially
Who cannot join
- A primary active mental illness diagnosis other than schizophrenia
- subjects whose psychotic symptoms can be explained by substance intake or medical illness
- pregnancy, breast-feeding, or planning to become pregnant
- a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)
- unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study
About this study
Official title: A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia
The purpose of this study is to evaluate the efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia.
Read the detailed description
This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo controlled, parallel group study to compare the efficacy and safety of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day 14) patients receive increasing doses of the treatment to which they are assigned (starting with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo). During the second phase (Day 15 - Day 42), patients continue to take the dose of medication they received on day 14, but may also receive other medications if the investigator determines they are needed to treat ongoing symptoms. The hypothesis of the study is that paliperidone ER is better than quetiapine in the short term for treating acutely ill patients with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14). Secondary outcomes include time to response, time to readiness for discharge, and additional medication use in the second phase of the study (Day 15- Day 42) for patients receiving paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may participate in a pharmacogenomic (DNA) analysis, if they choose to do so. Patients receive study drug by mouth for a total of 42 days. Study medications will be increased to maximum tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg or 800mg at day 8. From day 15 through day 42 (end of study) all patients will be eligible for additional psychotropic medications at investigators' discretion.
- Conditions
- Schizophrenia
- Being tested
- paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulated
- Keywords
- Schizophrenia, Antipsychotic, paliperidone, quetiapine, Seroquel, placebo
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone ER tablets, quetiapine tablets, placebo - all over encapsulatedDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14
Secondary outcomes (1)
Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2006 (estimated)
- Study startApr 2006
- Study completionSep 2007
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
- 399 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- 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
- NCT00334126
- Sponsor's protocol ID
- CR010501
- Status last verified
- Mar 2010
- First submitted
- 2 Jun 2006
- Last updated
- 18 May 2011
- Results posted
- No
Publications
Canuso CM, Dirks B, Carothers J, Kosik-Gonzalez C, Bossie CA, Zhu Y, Damaraju CV, Kalali AH, Mahmoud R. Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry. 2009 Jun;166(6):691-701. doi: 10.1176/appi.ajp.2009.08040613. Epub 2009 May 1.
PubMed 19411369
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
- A Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Paliperidone ER Compared to Quetiapine in Subjects With an Acute Exacerbation of Schizophrenia
- ClinicalTrials.gov ID
- NCT00334126
- Acronym / sponsor ID
- CR010501
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Antipsychotic, paliperidone, quetiapine, Seroquel, placebo
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 399 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Collaborators
- Janssen, LP
- Study start
- Apr 2006
- Study completion
- Sep 2007 (actual)
- First posted
- 6 Jun 2006 (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 efficacy (effectiveness of drug) and safety of the antipsychotic paliperidone ER compared to another antipsychotic, quetiapine, and to placebo in patients who are acutely ill with symptoms of schizophrenia.
Detailed description
This is a randomized (patients are assigned different treatments based on chance), double blind (neither the patient nor the physician knows whether drug or placebo is being taken, or at what dosage), placebo controlled, parallel group study to compare the efficacy and safety of paliperidone ER with quetiapine in the treatment of patients who have schizophrenia and are acutely ill. The duration of the study is 42 days. During the first phase (Day 0 - Day 14) patients receive increasing doses of the treatment to which they are assigned (starting with 3mg and increasing to 9 mg or 12 mg of paliperidone ER; starting with 50 mg and increasing to 600 mg or 800 mg of quetiapine; or the same number of capsules of placebo). During the second phase (Day 15 - Day 42), patients continue to take the dose of medication they received on day 14, but may also receive other medications if the investigator determines they are needed to treat ongoing symptoms. The hypothesis of the study is that paliperidone ER is better than quetiapine in the short term for treating acutely ill patients with schizophrenia. Primary outcome is change on the total score of the PANSS (Positive and Negative Syndrome scale for Schizophrenia) in the first phase of the study (Day 0 - Day 14). Secondary outcomes include time to response, time to readiness for discharge, and additional medication use in the second phase of the study (Day 15- Day 42) for patients receiving paliperidone ER compared to quetiapine. Safety of paliperidone ER compared with quetiapine throughout the study (Day 0 - Day 42) will be based on reported adverse events, results of laboratory tests (hematology, biochemistry, and urinalysis), vital signs (blood pressure, pulse, and weight), electrocardiogram, and movement disorder scales (Abnormal Involuntary Movement Scale, Barnes Akathisia Scale, and Simpson-Angus Rating Scale). Patients may participate in a pharmacogenomic (DNA) analysis, if they choose to do so. Patients receive study drug by mouth for a total of 42 days. Study medications will be increased to maximum tolerated doses of Paliperidone ER 9mg or 12mg/day and Quetiapine 600mg or 800mg at day 8. From day 15 through day 42 (end of study) all patients will be eligible for additional psychotropic medications at investigators' discretion.
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 (4 listed)
- Diagnostic and Statistical Manual - Fourth Edition (DSM-IV) diagnosis of schizophrenia (paranoid, disorganized or undifferentiated type)
- score of >=4 on at least two of a subset of selected PANSS items and a total score on these five items of >=17
- score of >=5 on the CGI-S (clinical global impression - severity)
- body weight of at least 60kg and willing to be hospitalized for 9 days initially
Key exclusion criteria (5 listed)
- A primary active mental illness diagnosis other than schizophrenia
- subjects whose psychotic symptoms can be explained by substance intake or medical illness
- pregnancy, breast-feeding, or planning to become pregnant
- a history of treatment resistance (defined by failure to respond to 2 adequate trials of different antipsychotic medications or clozapine given at adequate dose for sufficient time)
- unstable or significant medical illness that would increase risk of taking study medication or would confuse the interpretation of the study
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 tablets, quetiapine tablets, placebo - all over encapsulated | Drug | – |
Primary outcome
Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14
1 secondary outcome
Time to response (based on reduction in PANSS plus Clinical Global Impression - Change) and readiness for discharge, utilization of health care resources and polypharmacy use in patients receiving paliperidone ER or quetiapine
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 19411369Canuso CM, Dirks B, Carothers J, Kosik-Gonzalez C, Bossie CA, Zhu Y, Damaraju CV, Kalali AH, Mahmoud R. Randomized, double-blind, placebo-controlled study of paliperidone extended-release and quetiapine in inpatients with recently exacerbated schizophrenia. Am J Psychiatry. 2009 Jun;166(6):691-701. doi: 10.1176/appi.ajp.2009.08040613. Epub 2009 May 1.
- A randomized, double blind, placebo-controlled, parallel group study to evaluate the efficacy and safety of paliperidone ER compared to quetiapine in subjects with an acute exacerbation 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 of 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?
Reduction in total PANSS ( Positive and Negative Syndrome Scale) from baseline to endpoint at Day 14. 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 NCT00334126, 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.