SchizophreniaNCT00697658
INVISION - An Observational Study to Explore Effectiveness, Tolerability and Safety of Paliperidone ER in Patients With Schizophrenia
An observational study of Schizophrenia, run by Janssen-Cilag B.V. at 17 sites in Netherlands.
Trial summary
The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. 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
- Type of treatment
- Pill or oral medicine
- How many people
- 27 participants
- Where
- 17 sitesNetherlands
- Study dates
- Mar 2008to Nov 2009
- Phase
- Observational
- 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
Study population: Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the common practice of participating physicians. Patients may enter the study as soon as their paliperidone ER treatment starts or when it has been less than 14 days after their treatment start.
Who may be able to join
- Patient meets the DSM-IV criteria for schizophrenia
- Switched to or started on paliperidone ER, not longer than two weeks ago
- In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
- Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER
Who cannot join
- No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER
- No participation in an investigational drug trial in 30 days prior to starting paliperidone ER
- No history of neuroleptic malignant syndrome
- No known hypersensitivity to paliperidone ER or risperidone
- No patients hospitalized for a period longer than 12 weeks
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
Netherlands17 sites
Study site
Alphen aan den Rijn
Study site
Amersfoort
Study site
Amsterdam
Study site
Beverwijk
Study site
Deventer
Study site
Echt
Study site
Enschede
Study site
Geldrop
Study site
Heerde
Study site
Heerenveen
Study site
Hoorn
Study site
Kampen
Study site
Nijmegen
Study site
Purmerend
Study site
Roermond
Study site
Vlaardingen
Study site
Zwolle
About this study
Official title: INVega Is Studied In an Observational Design in the Netherlands
The purpose of this study is to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.
Read the detailed description
This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.
The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Paliperidone ER, Schizophrenia
- 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
6 mg tablet once daily, variable treatment length.
| Study group | Role | What they receive |
|---|---|---|
| 001 | Not described Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in CGI-S score at the end of the study
Measured: Week 26 or drop out visit
Secondary outcomes (3)
Change in Health of the Nation Outcome Scales (HoNOS)
Measured: Week 26 or drop out visit
Change in GAF score
Measured: Week 26 or drop out visit
Patient satisfaction with treatment
Measured: Week 26 or drop out visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2008 (estimated)
- Study startMar 2008
- Primary completionNov 2009
- Study completionNov 2009
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
- Observational
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag B.V.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag B.V. Clinical Trial, Study director, Janssen-Cilag B.V.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00697658
- Sponsor's protocol ID
- CR014788
- Other IDs
- R076477SCH4017
- Status last verified
- Apr 2014
- First submitted
- 11 Apr 2008
- Last updated
- 28 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVega Is Studied In an Observational Design in the Netherlands
- ClinicalTrials.gov ID
- NCT00697658
- Acronym / sponsor ID
- CR014788
- Conditions
- Schizophrenia
- Keywords
- Paliperidone ER, Schizophrenia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Janssen-Cilag B.V.Industry (pharma, biotech, devices)
- Study start
- Mar 2008
- Primary completion
- Nov 2009 (actual)
- Study completion
- Nov 2009 (actual)
- First posted
- 16 Jun 2008 (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 explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting.
Detailed description
This is an observational, prospective, multicenter 6-month study to explore efficacy, tolerability and safety of paliperidone Extended Release (ER) in 250 schizophrenia patients who started treatment with paliperidone ER in a naturalistic setting. The primary objective is to explore changes in Clinical Global Impression of Severity (CGI-S) score from baseline up to 26 weeks, in subgroups of schizophrenia patients who started treatment with paliperidone ER. Secondary objectives are: 1) To explore changes in mental health and social functioning based on routine outcome assessments in the Netherlands, the Health of the Nation Outcome Scales (HoNOS) and Global Assessment of Functioning (GAF), in schizophrenia patients who started treatment with paliperidone ER ; 2) To explore changes in patient's satisfaction with treatment, changes in number of ambulant contacts, changes in body weight, changes in concomitant therapy and to explore adverse events in schizophrenia patients who started treatment with paliperidone ER; and to explore possible association between CGI-S, GAF and HoNOS.
The patients will receive paliperidone ER (6 mg, 9 mg or other dosages as directed on the label) once daily for the period of 6 month. Which dosage of paliperidone ER the patients receive will be at the discretion of the investigator and according the Summary of Product Characteristics (SmPC). Because the study is observational, dosage, administration and duration of treatment is at discretion of treating physician.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | – | Drug: Paliperidone ER |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Schizophrenia patients meeting DSM-IV criteria receiving paliperidone ER, as part of the common practice of participating physicians. Patients may enter the study as soon as their paliperidone ER treatment starts or when it has been less than 14 days after their treatment start.
Key inclusion criteria (4 listed)
- Patient meets the DSM-IV criteria for schizophrenia
- Switched to or started on paliperidone ER, not longer than two weeks ago
- In 24 hours before initiation of paliperidone ER treatment, CGI-S, patient satisfaction with treatment, concomitant therapy, body weight, GAF and HoNOS data are available
- Patient or legal representative has signed the informed consent form within two weeks after starting treatment with paliperidone ER
Key exclusion criteria (5 listed)
- No use of paliperidone ER, clozapine, any conventional depot neuroleptic or long acting atypical antipsychotic drugs during 3 months before starting paliperidone ER
- No participation in an investigational drug trial in 30 days prior to starting paliperidone ER
- No history of neuroleptic malignant syndrome
- No known hypersensitivity to paliperidone ER or risperidone
- No patients hospitalized for a period longer than 12 weeks
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 ER6 mg tablet once daily, variable treatment length. | Drug | 001 |
Primary outcome
Change from baseline in CGI-S score at the end of the study
Time frame: Week 26 or drop out visit
3 secondary outcomes
Change in Health of the Nation Outcome Scales (HoNOS)
Time frame: Week 26 or drop out visit
Change in GAF score
Time frame: Week 26 or drop out visit
Patient satisfaction with treatment
Time frame: Week 26 or drop out visit
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 28 Apr 2014.
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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-Cilag B.V. Clinical Trial study director
Janssen-Cilag B.V.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Schizophrenia, run by Janssen-Cilag B.V. at 17 sites in Netherlands.
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 28 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
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 CGI-S score at the end of the study (time frame: Week 26 or drop out visit). 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 28 Apr 2014.