SchizophreniaNCT01698216
Switching From Consta® to Sustenna® in Patients With Schizophrenia
An observational study of Schizophrenia, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- Type of treatment
- Injection or infusion
- How many people
- 50 participants
- Where
- 1 siteSouth Korea
- Study dates
- Dec 2011to May 2015
- 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: Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection
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.
- Maintenance therapy more than 6 months with Risperidone Long Acting Injection monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone Long Acting Injection was maintained 8 weeks more. The stable dose of other antipsychotics has been maintained 8 months and more.
- Patient wants to switch antipsychotics to Paliperidone Palmitate.
- PANSS total score ≤ 80
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- Each score of conceptual disorganization(P2), hallucinatory behavior(P3), Suspiciousness/persecution(P6), unusual thought content(G9)in PANSS ≤ 4
- 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 use.
- Past history of NMS.
- Allergy or hypersensitivity to Risperidone or Paliperidone ER.
- Concomitant antipsychotics was oral Risperidone or Paliperidone ER.
- Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study)
- Initiating of Lithium, Valproic acid, Carbamazepine, Topiramate, Lamotrigine or other mood stabilizer within 2months (maintenance is allowed).
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- 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 substance dependence(DSM-IV) or past history of dependence (more than 6months)
- Significant biochemical or hematological abnormality or abnormal finding of urinalysis, based on clinician's opinion.
- History of cardiac disease which predispose to QT prolongation(sick sinus, complete AV block, CHF, ventricular tachycardia, hypokalemia or hypocalcemia) or current medication of QT prolonging drugs
- Pregnant or breast-feeding female patient.
- 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: Switching From Risperidone Long Acting Injection (Consta®) to Paliperidone Palmitate (Sustenna®) in Patients With Schizophrenia and Its Influence on Subjective Well-Being: A Prospective Observational Study
The aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.
Read the detailed description
In this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. And investigators will examine the effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side effect related variables will be studied.
- Conditions
- Schizophrenia
- Keywords
- Paliperidone, Palmitate, switching, schizophrenia, subjective well-being
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Consta Sustenna switching | The patients group who switched to paliperidone palmitate from risperidone long acting injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subjective Well-being Under Neuroleptic Treatment (SWN)
Measured: Change from Baseline in SWN score at 108 weeks
Secondary outcomes (12)
Korean Drug Attitude Inventory-10
Measured: Change from Baseline in score at 108 weeks
Positive and Negative Syndrome Scale
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Clinical Global Impression-Severity, Improvement
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Personal and Social Performance Scale
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Symptom Check List-90-Revised
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Drug-Induced ExtraPyramidal Symptoms Scale
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Liverpool University Neuroleptic Side Effect Rating Scale
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
Visual Analog Scale
injection site pain
Measured: 0,4,8,16,24,36,48,60,72,84,96,108 week
ECG
electrocardiogram
Measured: 8, 24, 48, 72, 108 week
blood pressure
Measured: 0,4,8,16,24,48,72,108 week
Body weight
Measured: 0,4,8,16,24,48,72,108 week
waist circumference
Measured: 0,4,8,16,24,48,72,108 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2012 (estimated)
- Study startDec 2011
- Primary completionMay 2015
- Study completionMay 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 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, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01698216
- Sponsor's protocol ID
- Consta_Sustenna
- Status last verified
- Dec 2015
- First submitted
- 27 Sep 2012
- 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
- Switching From Risperidone Long Acting Injection (Consta®) to Paliperidone Palmitate (Sustenna®) in Patients With Schizophrenia and Its Influence on Subjective Well-Being: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT01698216
- Acronym / sponsor ID
- Consta_Sustenna
- Conditions
- Schizophrenia
- Keywords
- Paliperidone, Palmitate, switching, schizophrenia, subjective well-being
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Dec 2011
- Primary completion
- May 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 2 Oct 2012 (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 aim of this study is observation of effectiveness and side effect of patients with schizophrenia who will switch the antipsychotics from risperidone long acting injection to paliperidone palmitate.
Detailed description
In this study, investigators are going to enroll the patients who will switch the risperidone long acting injection to paliperidone palmitate. And investigators will examine the effectiveness and side effect of paliperidone palmitate. In addition, effectiveness and side effect related variables will be studied.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Consta Sustenna switching | – | –The patients group who switched to paliperidone palmitate from risperidone long acting injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with schizophrenia who would be switched to Paliperidone Palmitate from Risperidone Long Acting Injection
Key inclusion criteria (9 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.
- Maintenance therapy more than 6 months with Risperidone Long Acting Injection monotherapy or other with concomitant antipsychotics, and stable dose of Risperidone Long Acting Injection was maintained 8 weeks more. The stable dose of other antipsychotics has been maintained 8 months and more.
- Patient wants to switch antipsychotics to Paliperidone Palmitate.
Key exclusion criteria (13 listed)
- No history of antipsychotics use.
- Past history of NMS.
- Allergy or hypersensitivity to Risperidone or Paliperidone ER.
- Concomitant antipsychotics was oral Risperidone or Paliperidone ER.
- Initiating or dose-changing of SSRI, MAOI, TCA within 2 months(maintenance is allowed if those have been stable for at least 30days prior to study entry and would not be any dose changes during the study)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Subjective Well-being Under Neuroleptic Treatment (SWN)
Time frame: Change from Baseline in SWN score at 108 weeks
12 secondary outcomes
Korean Drug Attitude Inventory-10
Time frame: Change from Baseline in score at 108 weeks
Positive and Negative Syndrome Scale
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Clinical Global Impression-Severity, Improvement
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Personal and Social Performance Scale
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Symptom Check List-90-Revised
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Drug-Induced ExtraPyramidal Symptoms Scale
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Liverpool University Neuroleptic Side Effect Rating Scale
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
Visual Analog Scale
Time frame: 0,4,8,16,24,36,48,60,72,84,96,108 week
ECG
Time frame: 8, 24, 48, 72, 108 week
blood pressure
Time frame: 0,4,8,16,24,48,72,108 week
Body weight
Time frame: 0,4,8,16,24,48,72,108 week
waist circumference
Time frame: 0,4,8,16,24,48,72,108 week
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 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?
An observational study of 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 9 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.
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?
Subjective Well-being Under Neuroleptic Treatment (SWN) (time frame: Change from Baseline in SWN score at 108 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.