SchizophreniaPhase 4NCT02075528
Early Prediction of Clinical Response in Patients With Schizophrenia Treated by Paliperidone ER
A Phase 4 study testing Paliperidone ER in people with Schizophrenia and Schizoaffective Disorder, run by Taipei City Hospital at 1 site in Taiwan.
Trial summary
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Paliperidone ER
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteTaiwan
- Study dates
- Jul 2009to Jul 2012
- 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
- diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- a minimal baseline total score of 60 on the PANSS
- those who had not received long-acting antipsychotic injection for the preceding 6 months
- physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.
Who cannot join
- diagnosis of substance (including alcohol) dependence in the previous 6 months
- a medical condition that could affect absorption, metabolism, or excretion of the study drug
- substantial risk of suicide or violent behavior
- pregnancy or breastfeeding
- documented organic disease of the central nervous system
- unstable or critical untreated medical illness
- history of clozapine treatment in the previous 3 months
- participation in an investigational drug trial in the 30 days before screening.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.
The primary aim of this study is to investigate:
- . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
- . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study
Read the detailed description
Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Paliperidone ER
- Keywords
- Paliperidone, Treatment response, Schizophrenia, Early prediction, Pharmacokinetics
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
Also called 9-hydroxyrisperidone
9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone Extended Release (ER) | Experimental | The participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge. Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)
Measured: Baseline (day 0) and Day 42
Secondary outcomes (1)
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)
Measured: Day 0 and 42
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2014 (estimated)
- Study startJul 2009
- Primary completionMay 2012
- Study completionJul 2012
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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Taipei City Hospital
- Sponsor type
- Other government
- Collaborators
- Johnson & Johnson Taiwan Ltd, Taipei Institute of Pathology
- Responsible party
- Sponsor
- Investigators
- MING-CHYI HUANG, M.D., Ph.D., Principal investigator, Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02075528
- Sponsor's protocol ID
- EPP-2009-OLS
- Status last verified
- Feb 2014
- First submitted
- 25 Feb 2014
- Last updated
- 3 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Prediction of Clinical Response, Metabolic Change, and Pharmacokinetics in Taiwanese Patients With Schizophrenia Patients Treated by Paliperidone ER: an Open-Label Study
- ClinicalTrials.gov ID
- NCT02075528
- Acronym / sponsor ID
- EPP-2009-OLS
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Keywords
- Paliperidone, Treatment response, Schizophrenia, Early prediction, Pharmacokinetics
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Taipei City HospitalOther government
- Collaborators
- Johnson & Johnson Taiwan Ltd, Taipei Institute of Pathology
- Study start
- Jul 2009
- Primary completion
- May 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 3 Mar 2014 (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.
Paliperidone ER is a new psychotropic medication for schizophrenia treatment. The studies of 6-week acute treatment and 52-week maintenance treatment showed positive results in patients with schizophrenia and its clinical improvement may start at Day 4. Some second-generation antipsychotics have been found that using the first 2 weeks' treatment results to predict the fourth or sixth week's treatment response is acceptable.
The primary aim of this study is to investigate:
- . whether the early prediction model used in other atypicals could also be applied in paliperidone ER.
- . The changes of metabolic parameters and pharmacokinetics after paliperidone ER treatment in this study
Detailed description
Patients diagnosed with schizophrenia or schizoaffective disorders will be enrolled in the 6-week trial. Eligible patients will receive 9mg paliperidone ER first. Then, the dosage of paliperidone could be adjusted two weeks later according to clinical judgement. They will be followed and receive assessment of pharmacokinetics, metabolic parameters ( lipid profiles, glucose, insulin, adiponectin, leptin, and prolactin, etc.), and the treatment response.
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 ERThe participants were assigned to receive a fixed dosage of 9 mg/d of paliperidone ER for the first 2 weeks. The paliperidone ER dosage was adjusted flexibly after 2 weeks according to the clinical judgment of the physicians in charge. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of schizophrenia or schizoaffective disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition (DSM-IV)
- a minimal baseline total score of 60 on the PANSS
- those who had not received long-acting antipsychotic injection for the preceding 6 months
- physically healthy and standard clinical laboratory test results within laboratory reference ranges, or if outside the ranges, judged to be clinically insignificant by the investigators.
Key exclusion criteria (8 listed)
- diagnosis of substance (including alcohol) dependence in the previous 6 months
- a medical condition that could affect absorption, metabolism, or excretion of the study drug
- substantial risk of suicide or violent behavior
- pregnancy or breastfeeding
- documented organic disease of the central nervous system
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 ERAlso: 9-hydroxyrisperidone9 mg/d of paliperidone ER was administered during the first 2 weeks, after which the dose was adjusted clinically | Drug | Paliperidone Extended Release (ER) |
Primary outcome
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline (day 0) and Day 42
1 secondary outcome
Metabolic parameters(including lipid profiles, fasting glucose, adiponectin, leptin, and insulin, and prolactin)
Time frame: Day 0 and 42
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 3 Mar 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.
MING-CHYI HUANG, M.D., Ph.D. principal investigator
Department of Psychiatry, Taipei City Hospital, Songde Branch, Taipei, Taiwan
1 site 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 ER in people with Schizophrenia and Schizoaffective Disorder, run by Taipei City Hospital at 1 site in Taiwan.
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 8 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 3 Mar 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. 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?
Responder: more than 50% improvement on the total score of the Positive and Negative Syndrome Scale (PANSS) (time frame: Baseline (day 0) and Day 42). 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 3 Mar 2014.