SchizophreniaPhase 4sustennaNCT01860781
The Effect of Paliperidone Palmitate in Schizophrenia
A Phase 4 study testing paliperidone palmitate in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients. 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 palmitate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteSouth Korea
- Study dates
- Aug 2011to Dec 2015
- 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
- Age: 18 ~ 65
- Patient with schizophrenia according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- PANSSS total score <120
- each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
- three different groups ( other antipsychotics refractory schizophrenia patitents : CGI> 4 chronic akathisia : DIEPSS overall severity >1, at least 1 month lasting symptoms poor compliance schizophrenia : CRS <3)
- Competent patient who is manage to answer the questionnaires.
- In case of female at child-bearing age, consent to use appropriate contraceptive methods(oral pill, contraceptive injection, intrauterine device, double barrier method and contraceptive patch) during entire duration of this study.
Who cannot join
- No history of antipsychotics prescription
- History of NMS(Neuroleptic malignant syndrome)
- Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
- clozapine medication within 1 month before screening
- SSRI, MAOI, TCA medication within 2 months
- Lithium, valproic acid, carbamazepine, topiramate, lamotrigine medication starting within 2 months
Show all 13Show fewer
- patient who is supposed to be impossible to participate to this study due to clinical risk of suicide or aggressive behavior based on clinician's opinion
- current or previous history of drug depedence according to DSM-IV
- Pregnant or breast-feeding female patient
- Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion
- history of cardiac disease, which is related to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia)
- History of participating to other investigational drug trial within 1month prior to screening
- Investigator or employee at clinical trial center, personnel related to investigator or trial center on this or other study, or family of employee or investigator
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study
The purpose of this study is the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.
Read the detailed description
In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.
- Conditions
- Schizophrenia
- Being tested
- paliperidone palmitate
- Keywords
- Schizophrenia, Injection, Switch, Paliperidone, refractory, chronic akathisia, poor complianc
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
paliperidone palmitateDrug
Also called paliperidone palmitate(sustenna)
paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly)
| Study group | Role | What they receive |
|---|---|---|
| paliperidone palmitate | Experimental | paliperidone palmitate Receives: Drug: paliperidone palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
CGI-S,I: Clinical Global Impression-Severity, Improvement
Measured: 24 weeks
Secondary outcomes (7)
PANSS: Positive and Negative Syndrome Scale
Measured: 24 weeks
CRS: Clinician Rating Scale
Measured: 24 weeks
KDAI-10: Korean Drug Attitude Inventory-10
Measured: 24 weeks
SWN: Subjective Well-being Under Neuroleptic Treatment
Measured: 24 weeks
DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae
Measured: 24 weeks
injection site pain -VAS: Visual Analog Scale
Measured: 24 weeks
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2013 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionDec 2015
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.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yong Min Ahn, Seoul National University Hospital
- Investigators
- Yong Min Ahn, MD, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01860781
- Sponsor's protocol ID
- R092670-SCH-4008
- Acronym
- sustenna
- Status last verified
- Dec 2015
- First submitted
- 21 May 2013
- Last updated
- 8 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Paliperidone Palmitate in Schizophrenia: A Prospective Naturalistic Case Series Study
- ClinicalTrials.gov ID
- NCT01860781
- Acronym / sponsor ID
- sustenna / R092670-SCH-4008
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Injection, Switch, Paliperidone, refractory, chronic akathisia, poor complianc
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 23 May 2013 (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 the evaluation of effectiveness of paliperidone palmitate within three different group of schizophrenia patients.
Detailed description
In this study, the investigators are going to examine the effectiveness of paliperidone palmitate after changing from other antipsychotics. This study design is a Prospective Naturalistic Case Series Study. The effectiveness of paliperidone would be compared within three different groups of schizophrenia. Investigators would also assess the safety during 24 weeks follow up period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| paliperidone palmitate | Experimental | Drug: paliperidone palmitatepaliperidone palmitate |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age: 18 ~ 65
- Patient with schizophrenia according to DSM-IV criteria
- Patient have signed on the informed consent, and well understood the objective and procedure of this study.
- PANSSS total score <120
- each Score of disorganized thought, paranoia hallucinatory behavior, abnormal tbought contests < 16
Key exclusion criteria (13 listed)
- No history of antipsychotics prescription
- History of NMS(Neuroleptic malignant syndrome)
- Allergic reaction or hypersensitive reaction of risperidone or paliperidone ER
- clozapine medication within 1 month before screening
- SSRI, MAOI, TCA medication within 2 months
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 palmitateAlso: paliperidone palmitate(sustenna)paliperidone palmitate 150mgeq(1 day), 100mgeq(8days), 75mg(monthly) | Drug | paliperidone palmitate |
Primary outcome
CGI-S,I: Clinical Global Impression-Severity, Improvement
Time frame: 24 weeks
7 secondary outcomes
PANSS: Positive and Negative Syndrome Scale
Time frame: 24 weeks
CRS: Clinician Rating Scale
Time frame: 24 weeks
KDAI-10: Korean Drug Attitude Inventory-10
Time frame: 24 weeks
SWN: Subjective Well-being Under Neuroleptic Treatment
Time frame: 24 weeks
DIEPSS: Drug-Induced ExtraPyramidal Symptoms Sclae
Time frame: 24 weeks
injection site pain -VAS: Visual Analog Scale
Time frame: 24 weeks
LUNSERS: Liverpool University Neuroleptic Side Effect Rating Scale
Time frame: 24 weeks
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 8 Dec 2015.
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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.
Yong Min Ahn, MD, PhD principal investigator
Seoul National University Hospital
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 palmitate in people with Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
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 8 inclusion and 13 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 8 Dec 2015. 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 South Korea. 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?
CGI-S,I: Clinical Global Impression-Severity, Improvement (time frame: 24 weeks). 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 8 Dec 2015.