SchizophreniaPhase 4NCT00915512
A Phase 4 Study to Evaluate Response to Treatment and Safety of Paliperidone Extended-Release in Participants With Schizophrenia
A Phase 4 study testing Paliperidone extended-release (ER) in people with Schizophrenia, run by Janssen-Cilag Turkey at 7 sites in Turkey (Türkiye).
Trial summary
The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability… 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 extended-release (ER)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 7 sitesTurkey (Türkiye)
- Study dates
- May 2009to Oct 2011
- Phase
- Phase 4
- 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
- Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
- To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
- Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
- Participants who are willing and capable to complete the questionnaires
Who cannot join
- Use of clozapine, depot neuroleptics or risperidone within the last 3 months
- Any unstable clinical condition including clinically important abnormal laboratory findings
- Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
- History of malignant neuroleptic syndrome
- To be considered carrying high risk regarding adverse effects, homicide and/or suicide
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Turkey (Türkiye)7 sites
Study site
Adana
Study site
Ankara
Study site
Antalya
Study site
Bursa
Study site
Istanbul
Study site
Manisa
Study site
Samsun
About this study
Official title: An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia
The purpose of this study is to evaluate the response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Read the detailed description
This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone extended-release (ER)
- Keywords
- Schizophrenia, Paliperidone, Invega
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone extended-release (ER)Drug
Also called Invega
Paliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone extended-release (ER) | Experimental | Not described Receives: Drug: Paliperidone extended-release (ER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12
The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
Measured: Baseline and Month 12
Secondary outcomes (4)
Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12
The GAF is a 100-point tool to measure overall psychological, social and occupational functioning of adults. The higher score range (that is, 91 to 100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (that is, 1 to 10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Measured: Baseline and Month 12
Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12
The PANSS is a scale which measures the severity of psychotic symptoms of schizophrenia. Score ranges from 30 to 210 where 30=best and 210=worst. The scale consists of three subscales: positive subscale (Range 7 to 49), negative subscale (Range 7 to 49) and general psychopathology subscale (Range 16 to 112), which measures from absent to extreme condition. Higher scores indicate worsening.
Measured: Baseline and Month 12
Change from Baseline in Short Form (SF)-36 Scale Score at Month 12
The SF-36 is a survey that measures 8 domains of health including: physical functioning, role limitations due to physical health (role-physical), bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems (role-emotional) and general mental health. Each item is scored on a range of 0 to 100. Worst value is 0 and best value is 100.
Measured: Baseline and Month 12
Change from Baseline in Percentage of Participants With Relapse at Month 12
The relapse will be diagnosed if participants meet any of the following criteria on 2 consecutive evaluations conducted 3 to 5 days apart: Psychiatric hospitalization; increase in level of care necessary and 25 percent increase in total PANSS score from Baseline; significant clinical deterioration defined as a clinical global impression of change scale score of 6 (indicating much worse); deliberate self-injury; clinically significant suicidal or homicidal ideation; violent behavior resulting in significant injury to another person or property; exceeding the registered dose of drug.
Measured: Baseline and Month 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2009 (estimated)
- Study startMay 2009
- Primary completionOct 2011
- Study completionOct 2011
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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen-Cilag Turkey
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen-Cilag Turkey Clinical Trial, Study director, Janssen-Cilag Turkey
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00915512
- Sponsor's protocol ID
- CR016543
- Other IDs
- R076477SCH4027
- Status last verified
- Oct 2013
- First submitted
- 5 Jun 2009
- Last updated
- 10 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Single-arm, Multicenter, Phase IV Study to Evaluate the Response to Treatment and Safety of Flexible Dose Treatment With Extended-release Paliperidone in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT00915512
- Acronym / sponsor ID
- CR016543
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Invega
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Janssen-Cilag TurkeyIndustry (pharma, biotech, devices)
- Study start
- May 2009
- Primary completion
- Oct 2011 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 8 Jun 2009 (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 response to treatment and safety of paliperidone extended-release (mechanism to dissolve a drug over time in order to be released slower and steadier into the blood stream) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).
Detailed description
This is a non-randomized, single-arm, multi-center (conducted in more than one center) study to explore response to treatment and safety of flexible dose of paliperidone extended-release (ER) in participants with schizophrenia. During the study period, dose of paliperidone ER will remain within the range of 3 to 12 milligram per day and will be administered for 12 months. Both hospitalized and non-hospitalized participants may be included in the study. Participants may switch to any effective dose of paliperidone ER from any oral antipsychotic medication without dose adjustment or if required, cross-dose adjustment may be done. Maximum 4 weeks of switching period is allowed. Use of anticholinergic (opposing the actions of the acetylcholine, a neurotransmitter) drugs will not be restricted. Response to treatment will be evaluated primarily through total Personal and Social Performance (PSP) Scale. Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone extended-release (ER) | Experimental | Drug: Paliperidone extended-release (ER) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Schizophrenia diagnosis according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- Recent onset (less than 3 years after the first episode/hospitalization) schizophrenia but either not on antipsychotic medication for at least 3 months or in need of antipsychotic medication switches because of safety and/or lack of efficacy reasons
- To be considered physically healthy at Screening according to vital signs and physical examination findings. If there are abnormalities, they must be consistent with the underlying illness in the study population
- Women at postmenopausal state for at least 1 year; or undergone surgical sterilization, or for women with child-bearing status, should be willing to use an effective contraceptive method throughout the study
- Participants who are willing and capable to complete the questionnaires
Key exclusion criteria (5 listed)
- Use of clozapine, depot neuroleptics or risperidone within the last 3 months
- Any unstable clinical condition including clinically important abnormal laboratory findings
- Previous and current tardive dyskinesia (abnormal involuntary movements which primarily affect the extremities, trunk, or jaw) symptoms
- History of malignant neuroleptic syndrome
- To be considered carrying high risk regarding adverse effects, homicide and/or suicide
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 extended-release (ER)Also: InvegaPaliperidone ER tablets will be administered orally once daily as flexible dose ranging from 3 to 12 milligram (mg) per day for 12 months. The recommended dose will be 6 mg once daily. | Drug | Paliperidone extended-release (ER) |
Primary outcome
Change from Baseline in Total Personal and Social Performance (PSP) Score at Month 12
Time frame: Baseline and Month 12
The PSP is a clinician-rated scale that reflects social functioning in 4 domains of behavior (socially useful activities including work and study, personal and social relationships, self care, and disturbing and aggressive behaviors). The total score ranges from 1 to 100 (score of 71 to 100 will have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision) divided into 10 equal intervals to rate the degree of difficulty (i=absent to vi=very severe) in each of the 4 domains.
4 secondary outcomes
Change from Baseline in Global Assessment of Functioning (GAF) Score at Month 12
Time frame: Baseline and Month 12
Change from Baseline in Total Positive and Negative Syndrome Scale (PANSS) Score and Subscales Score at Month 12
Time frame: Baseline and Month 12
Change from Baseline in Short Form (SF)-36 Scale Score at Month 12
Time frame: Baseline and Month 12
Change from Baseline in Percentage of Participants With Relapse at Month 12
Time frame: Baseline and Month 12
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 10 Oct 2013.
- An open-label, single-arm, multicenter, phase IV study to evaluate the response to treatment and safety of flexible dose treatment with extended-release paliperidone in patients with 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.
Janssen-Cilag Turkey Clinical Trial study director
Janssen-Cilag Turkey
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Paliperidone extended-release (ER) in people with Schizophrenia, run by Janssen-Cilag Turkey at 7 sites in Turkey (Türkiye).
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 5 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 10 Oct 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 Total Personal and Social Performance (PSP) Score at Month 12 (time frame: Baseline and Month 12). 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 10 Oct 2013.