SchizophreniaPhase 2NCT00257023
An Exploratory Study on the Safety and Effectiveness of Paliperidone in Patients With Schizophrenia
A Phase 2 study testing paliperidone in people with Schizophrenia, run by Janssen Pharmaceutical K.K..
Trial summary
The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia Read more about this study
- Who is it for?
- Ages 20 to 64 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- paliperidone
- How many people
- 52 participants
- Where
- No sites listed yet
- Study dates
- Feb 2005to Sep 2005
- Phase
- Phase 2
- 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 20 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
- taking not more than one oral antipsychotic medication within 28 days of study entry
- a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia
Who cannot join
- Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
- history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
- drug allergy or hypersensitivity to antipsychotics
About this study
Official title: Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy
The purpose of this study is to assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia
Read the detailed description
Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and plasma concentration of paliperidone taken once daily in patients with schizophrenia. The patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale [DIESS] results, and adverse event monitoring) will be conducted throughout the study. The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia, and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of paliperidone, taken once daily by mouth for 6 weeks.
- Conditions
- Schizophrenia
- Being tested
- paliperidone
- Keywords
- Schizophrenia, Risperidone, Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), Positron Emission Tomography (PET)
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidoneDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS]
Secondary outcomes (1)
Changes measured throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a score on a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2005 (estimated)
- Study startFeb 2005
- Study completionSep 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00257023
- Sponsor's protocol ID
- CR004939
- Status last verified
- Jan 2011
- First submitted
- 18 Nov 2005
- Last updated
- 17 May 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study of Paliperidone in Patients With Schizophrenia to Investigate the Safety and Efficacy
- ClinicalTrials.gov ID
- NCT00257023
- Acronym / sponsor ID
- CR004939
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Risperidone, Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression (CGI), Positron Emission Tomography (PET)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Feb 2005
- Study completion
- Sep 2005 (actual)
- First posted
- 22 Nov 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 assess the safety, effectiveness, and plasma concentration of paliperidone (an antipsychotic medication) given once daily in the treatment of patients with schizophrenia
Detailed description
Paliperidone is an extended-release tablet. Paliperidone is an active metabolite of risperidone, not approved for the treatment of schizophrenia in Japan. This is a multicenter, open-label, parallel-group, fixed dose study to evaluate the safety, effectiveness, and plasma concentration of paliperidone taken once daily in patients with schizophrenia. The patients will receive a fixed dose of paliperidone (3, 9, and 15 mg) for 6 weeks and its effectiveness and safety will be observed for an additional 2 weeks.. Efficacy will be measured by determining changes throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score. In addition, the study also assesses the relationship between dose/plasma drug concentration and dopamine D2 receptor occupancy in patients who consent to receive positron emission tomography (PET). Safety evaluations (symptoms, physical exams, electrocardiograms, laboratory tests, Drug-Induced Extrapyramidal Symptoms Scale [DIESS] results, and adverse event monitoring) will be conducted throughout the study. The study hypothesis is that paliperidone will be effective in the treatment of schizophrenia, and that it will be well-tolerated. The patients will receive either 3, 9, or 15 mg of paliperidone, taken once daily by mouth for 6 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients diagnosed with schizophrenia according to the diagnostic criteria of DSM-IV
- taking not more than one oral antipsychotic medication within 28 days of study entry
- a score below 120 at pre-treatment on the Positive and Negative Syndrome Scale Score (PANSS), a scale for the measurement of symptoms of schizophrenia
Key exclusion criteria (3 listed)
- Diagnosis of psychiatric disease other than schizophrenia according to the diagnostic criteria of DSM-IV
- history of Parkinson's disease, seizure disorder, cerebrovascular accident, diabetes mellitus, clinically significant gastrointestinal disorders, or severe impairment of the liver or kidneys
- drug allergy or hypersensitivity to antipsychotics
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 | Drug | – |
Primary outcome
Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS]
1 secondary outcome
Changes measured throughout the study in the Positive and Negative Syndrome Scale (PANSS) score, a score on a scale for the measurement of symptoms of schizophrenia, and the Clinical Global Impression (CGI) score.
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 17 May 2011.
- Exploratory study of JNS007ER in patients with Schizophrenia to investigate the Safety and Efficacy.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.
Janssen Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing paliperidone in people with Schizophrenia, run by Janssen Pharmaceutical K.K..
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 3 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 17 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Safety assessments conducted throughout the study, including adverse events and results from the Drug-Induced Extrapyramidal Symptoms Scale [DIESS]. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 May 2011.