SchizophreniaPhase 4NCT01682161
A Comparative Study to Evaluate the Evolution of Medication Satisfaction and Adherence in Patients Unsatisfied With Current Oral Atypical Antipsychotics by Switching Medication to Paliperidone Palmitate
A Phase 4 study testing Paliperidone palmitate in people with Schizophrenia, run by Janssen Korea, Ltd., Korea at 9 sites in South Korea.
Trial summary
The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode. Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone palmitate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 9 sitesSouth Korea
- Study dates
- Jan 2012to Sep 2013
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- History of neuroleptic malignant syndrome
- Presence of congenital prolongation of the QT interval - History of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days
- Any relevant medical history or current presence of systemic disease
- Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
South Korea9 sites
Study site
Buchun
Study site
Cheonan
Study site
Chungcheongbuk-Do
Study site
Daegu
Study site
Goyang
Study site
Gyeonggi-do
Study site
Incheon
Study site
Seognam-Si, Kyungki-Do
Study site
Seoul
About this study
Official title: An Open-Label, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence
The purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.
Read the detailed description
This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.
The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.
Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.
The total duration of the study will be approximately 148 days.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone palmitate
- Keywords
- Schizophrenia, Paliperidone Palmitate, Invega Sustenna, Antipsychotics, Atypical antipsychotics, Medication Satisfaction and Adherence
- 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 INVEGA SUSTENNA
Paliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent.
| Study group | Role | What they receive |
|---|---|---|
| Group 1 (Immediate switch) | Experimental | Paliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase. Receives: Drug: Paliperidone palmitate |
| Group 2 (Delayed switch) | Experimental | Current oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered. Receives: Drug: Paliperidone palmitate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied.
Measured: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Secondary outcomes (5)
Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
The TSQM is a 14-item subject assessed evaluation of treatment medication using a 7-point Likert-type scale rated as follows: 1=Extremely Dissatisfied, 2=Very Dissatisfied, 3=Somewhat Dissatisfied, 4=Neither Satisfied Nor Dissatisfied, 5=Somewhat Satisfied, 6=Very Satisfied, 7= Extremely Satisfied.
Measured: Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)
The PANSS is a medical scale used for measuring symptom severity of patients with schizophrenia. The neuropsychiatric symptoms of schizophrenia will be assessed using the 30-item PANSS scale. Each item is rated as follows: 1=absent, 2=Minimal, 3=Mild, 4=Moderate, 5=Moderate Severe, 6=Severe, and 7=Extreme.
Measured: Baseline, Week 8, and Week 21
Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale
The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale. It is rated as follows: 1=Normal, not at all ill, 2=Borderline mentally ill, 3=Mildly ill, 4=Moderately ill, 5=Markedly ill, 6=Severely ill, and 7=Among the most extremely ill.
Measured: Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale
The PSP is a clinician rated instrument providing an overall rating of personal and social functioning in patients with schizophrenia on a scale of 1-100. The scale defines a continuum from grossly impaired functioning, in which total lack of autonomy in basic functioning and survival risk is evident, to excellent functioning. Four domains of functioning are considered in the rating: 1) socially useful activities, including work and study, 2) personal and social relationships, 3) self-care, and 4) disturbing and aggressive behavior.
Measured: Baseline, Week 8, and Week 21
Score of Mediation Adherence Rating Scale (MARS)
The MARS is a 10-items self-rating scale to measure the adherence of the drug medication for psychosis. Each item is answered "yes/no" and the total score ranges from 0 points (Low medication adherence) to 10 points (High medication adherence).
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2012 (estimated)
- Study startJan 2012
- Primary completionSep 2013
- Study completionSep 2013
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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Korea, Ltd., Korea
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Korea, Ltd., Korea Clinical Trial, Study director, Janssen Korea, Ltd., Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01682161
- Sponsor's protocol ID
- CR100740
- Other IDs
- R092670SCH4010, PALM-KOR-4001
- Status last verified
- Jul 2014
- First submitted
- 6 Sep 2012
- Last updated
- 1 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Comparative Study of Immediate or Delayed Switch to Paliperidone Palmitate in Patients Unsatisfied With Current Oral Atypical Antipsychotics to Evaluate the Evolution of Medication Satisfaction and Adherence
- ClinicalTrials.gov ID
- NCT01682161
- Acronym / sponsor ID
- CR100740
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone Palmitate, Invega Sustenna, Antipsychotics, Atypical antipsychotics, Medication Satisfaction and Adherence
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Janssen Korea, Ltd., KoreaIndustry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 10 Sep 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 purpose of this study is to evaluate the change of medication satisfaction measured by Medication Satisfaction Questionnaire (MSQ) from baseline to endpoint for patients who are switched into paliperidone palmitate, either immediately or in a delayed mode.
Detailed description
This is a prospective (patients are first identified and then followed forward as time passes), multicenter (study conducted at multiple sites), randomized (the study medication is assigned by chance), comparative and open-labeled (all people know the identity of the intervention) study.
The study mainly consists of 3 phases including, the screening phase (14 days before administration of study medication), treatment phase, and the follow-up phase (28 days after the last dose of the study medication). In the treatment phase, patients will be randomly assigned equally in 2 groups (Group 1 and Group 2), on the basis of known and unknown characteristics. Group 1 (immediate switch group): Patients will be administered with paliperidone palmitate immediately after randomization and will continue throughout the treatment phase. Group 2 (delayed switch group): Patients will remain on current oral antipsychotics until Week 8, and later on will be completely switched to paliperidone palmitate. However, during the first 8 weeks if the symptoms or satisfaction with MSQ further deteriorates for Group 2, they may be switched into paliperidone palmitate earlier.
Safety evaluations will include evaluation of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination and these will be monitored throughout the study.
The total duration of the study will be approximately 148 days.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 1 (Immediate switch) | Experimental | Drug: Paliperidone palmitatePaliperidone palmitate will be administered immediately after randomization and will be continued throughout the treatment phase. |
| Group 2 (Delayed switch) | Experimental | Drug: Paliperidone palmitateCurrent oral antipsychotics will be continued until Week 8, and later on paliperidone palmitate will be administered. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (4 listed)
- History of neuroleptic malignant syndrome
- Presence of congenital prolongation of the QT interval - History of treatment with depot antipsychotics, including long-acting injectable risperidone and paliperidone palmitate, within 90 days of the screening visit; or any treatment with clozapine within the previous 60 days
- Any relevant medical history or current presence of systemic disease
- Significant risk of suicidal, homicidal or violent ideation or behavior as clinically assessed by the investigator
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: INVEGA SUSTENNAPaliperidone palmitate will be administrated in accordance with each product's information. Recommended initial loading doses are 150 mg equivalent on Day 1 and 100 mg equivalent on Day 8, followed by subsequent once-monthly administration with 75 mg equivalent or flexible dose between 25 mg and 150 mg equivalent. | Drug | Group 1 (Immediate switch), Group 2 (Delayed switch) |
Primary outcome
Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ)
Time frame: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
MSQ is designed to assess treatment satisfaction among patients with schizophrenia. The responses will be assessed on a 7-point Likert-type scale rated as follows: 1=extremely dissatisfied, 2=very dissatisfied, 3=somewhat dissatisfied, 4=neither satisfied nor dissatisfied, 5=somewhat satisfied, 6=very satisfied, and 7=extremely satisfied.
5 secondary outcomes
Change from baseline to Week 21 in scores of Treatment Satisfaction Questionnaire for Medication (TSQM)
Time frame: Screening, baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Change from baseline to Week 21 in scores of Positive and Negative Syndrome Scale (PANSS)
Time frame: Baseline, Week 8, and Week 21
Change from baseline to Week 21 in scores of Clinical Global Impression - Severity (CGI-S) scale
Time frame: Baseline, Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21
Change from baseline to Week 21 in scores of Personal and Social Performance (PSP) scale
Time frame: Baseline, Week 8, and Week 21
Score of Mediation Adherence Rating Scale (MARS)
Time frame: Baseline
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 1 Aug 2014.
- An open-label, comparative study of immediate or delayed switch to paliperidone palmitate in patients unsatisfied with current oral atypical antipsychotics to evaluate the evolution of medication satisfaction and adherenceLink 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 Korea, Ltd., Korea Clinical Trial study director
Janssen Korea, Ltd., Korea
9 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 palmitate in people with Schizophrenia, run by Janssen Korea, Ltd., Korea at 9 sites 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 0 inclusion and 4 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 1 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites 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?
Change from baseline to Week 21 in scores of Medication Satisfaction Questionnaire (MSQ) (time frame: Screening (Week -2), baseline (Week 0), Week 1, Week 5, Week 8, Week 9, Week 13, Week 17, and Week 21). 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 1 Aug 2014.