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AzTrials

SchizophreniaPhase 4NCT01592201

A Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

A Phase 4 study testing Paliperdidone ER and Aripiprazole, olanzapine and risperidone (Antipsychotics) in people with Schizophrenia, run by Janssen Korea, Ltd., Korea at 9 sites in South Korea.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone) Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperdidone ER and Aripiprazole, olanzapine and risperidone (Antipsychotics)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
13 participants
Where
9 sitesSouth Korea
Study dates
Jul 2012to Jun 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

  • Must be diagnosed with schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria
  • Have taken atypical antipsychotics (aripiprazole, olanzapine, risperidone) at least 6 weeks prior to start of study.
  • Have Medication Satisfaction Questionnaire (MSQ) score of ≤3
  • Competent patients who manage to answer the questionnaires

Who cannot join

  • Have had a history or current symptoms of tardive dyskinesia or neuroleptic malignant syndrome
  • Have had relevant history of or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, morbid obesity (BMI≥40), or other systemic disease
  • Had received two or more different kind of antipsychotics.
  • Had a history of taking paliperidone extended release (ER).
  • Allergy or hypersensitivity to risperidone or paliperidone ER.
  • Have been on clozapine or long-acting injectable antipsychotic medication during the last 3 months.
Show all 10Show fewer
  • Have had Medication Satisfaction Questionnaire (MSQ) score>3
  • Have been hospitalized for longer than 8 continuous weeks during the past 6 months
  • Had history of any severe preexisting gastrointestinal narrowing (pathologic or iatrogenic) or inability to swallow the oral tolerability medication whole with the aid of water for patients requiring oral tolerability testing
  • Current substance dependence (DSM-IV) or past history of dependence (more than 6 months)

Trial locations and contacts

9 sites in 1 country.

9 sites in 1 country

South Korea9 sites

  • Study site

    Busan

  • Study site

    Cheonan

  • Study site

    Chuncheon

  • Study site

    Chungju

  • Study site

    Daegu

  • Study site

    Daejeon

  • Study site

    Goyang-si

  • Study site

    Gyeonggi-do

  • Study site

    Seoul

Other trials in South Korea

About this study

Official title: An Open-label, Prospective, Randomized and Comparative Study of Patient Satisfaction Between Continued Administration of Previous Antipsychotics Versus Switched Administration to Paliperidone ER in Non-satisfied Patients With Previous Antipsychotic Drug

The purpose of this study is to compare the patient satisfaction between continued administration of previous antipsychotics versus switched administration to paliperidone ER in non-satisfied patients with previous (paliperidone)

Read the detailed description

This is a randomized (patients are assigned to intervention by chance), prospective, open-label (all people involved know the identity of the assigned drug), switch study designed to evaluate patient-assessed medication satisfaction after 12 weeks of treatment in patients with schizophrenia. The total duration of this study is 12 weeks. Outpatients who treated atypical antipsychotics and report dissatisfaction (Medication Satisfaction Questionnaire [MSQ] <4) with their current treatment response are eligible to participate in the study. Patients will be randomized into two groups, 1) Patients randomized to an immediate initiation of paliperidone ER for a total 12 weeks 2) Patients randomized to a delayed initiation will continue their previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. During the study treatment optimization will be done by dose adjustment (dose increase or decrease) and by adding psychotropic agents except the antipsychotics.

Conditions
Schizophrenia
Being tested
Paliperdidone ER, Aripiprazole, olanzapine and risperidone (Antipsychotics)
Keywords
Schizophrenia, Paliperidone ER, Antipsychotics, Mental disorder, Comparative study
Medical subject headings
Schizophrenia, Mental Disorders

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Paliperdidone ERDrug

    Form = osmotic release oral system, route = oral

  • Aripiprazole, olanzapine and risperidone (Antipsychotics)Drug

    Form = tablet, route = oral

Study groups in NCT01592201
Study groupRoleWhat they receive
Paliperidone ERExperimentalImmediate initiation of Paliperidone ER for a total of 12 weeks
Receives: Drug: Paliperdidone ER
Antipsychotics and paliperidone ERExperimentalDelayed initiation included previous atypical antipsychotics for 8 weeks and then be initiated on paliperidone ER at Day 56 for 4 weeks. The atypical antipsychotics includes aripiprazole, olanzapine and risperidone. These antipsychotics belongs to the class of second generation bipolar atypical antipsychotics.
Receives: Drug: Paliperdidone ER; Drug: Aripiprazole, olanzapine and risperidone (Antipsychotics)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change From Baseline in the medication satisfaction questionnaire (MSQ) score at Week 8

    A single-item, global, patient-completed instrument that is read aloud to patients by clinicians designed to assess treatment satisfaction among patients with schizophrenia. It consists of one question: "Overall, how satisfied are you with your current antipsychotic medication(s)?" with responses assessed on a 7-point 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: Baseline and Week 8

Secondary outcomes (8)

  1. Positive and negative symptoms scale (PANSS) score

    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme). It's designed to capture symptoms of schizophrenia. (Gold standard)

    Measured: Baseline to Week 12

  2. Drug Attitude Inventory (DAI)-10 Score

    DAI-10 is a 10-item scale developed to assess how the attitude of schizophrenia patients toward their medications may affect compliance (-10~+10)

    Measured: Baseline to Week 12

  3. Clinical Global Impression-Severity (CGI-S) Score

    The CGI-S rating scale is used to rate the severity of a patient's psychotic condition on a 7-point scale ranging from 1 (not ill) to 7 (extremely severe)

    Measured: Baseline to Week 12

  4. Personal and Social Performance Scale (PSP)

    This scale assesses the degree of dysfunction a patient exhibits within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The score ranges from 1 to 100, divided into 10 equal intervals to rate the degree of difficulty (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patient's with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; ≤ 30, functioning so poorly as to require intensive supervision

    Measured: Baseline to Week 12

  5. Sleep Visual Analog Scale (Sleep VAS)

    This self-administered scale rates quality of sleep and daytime drowsiness. Patient's will indicate on an 11- point scale (from 0 to 10) how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). On the sleep evaluation scale, score '0' corresponds to 'very badly' and score '10' to 'very well'. On the daytime drowsiness scale, score '0' corresponds to 'not at all' and score '10' to 'all the time

    Measured: Baseline to Week 12

  6. Number of patients with adverse events

    Measured: Baseline to Week 12

  7. Number of patients with vital signs and physical examination

    Measured: Baseline to Week 12

  8. Number of patients with laboratory test (prolactin, blood glucose, glycosylated hemoglobin, cholesterol, triglyceride)

    Measured: Baseline to Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionJun 2013
  4. Study completionJun 2013

Why it stopped: This study was early terminated due to insufficient enrollment required for hypothesis testing.

Resources

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
13 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01592201
Sponsor's protocol ID
CR100782
Other IDs
PAL-KOR-4019, R076477SCH4064
Status last verified
Jun 2014
First submitted
10 Feb 2012
Last updated
25 Jun 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paliperdidone ER and Aripiprazole, olanzapine and risperidone (Antipsychotics) 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 4 inclusion and 10 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: stopped early, as of the sponsor's last update on 25 Jun 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 was stopped early (reason given: This study was early terminated due to insufficient enrollment required for hypothesis testing.). Results are not available in the source record.

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 the medication satisfaction questionnaire (MSQ) score at Week 8 (time frame: Baseline and Week 8). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592201.

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 25 Jun 2014.

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Clinical Trial NCT01592201 | AzTrials