AzTrials
AzTrials

SchizophreniaPhase 4NCT01670071

A Study to Evaluate the Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Cognitive Function in Clinically Stable Patients With Schizophrenia

A Phase 4 study testing Paliperidone extended-release and Risperidone immediate-release in people with Schizophrenia, run by Johnson & Johnson Taiwan Ltd at 3 sites in Taiwan.

Terminated

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

Official record
Search all trials

Trial summary

The purpose of this study is to compare the effect of oral paliperidone extended-release and oral risperidone immediate-release on cognitive function, especially the category fluency of Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an established diagnosis of schizophrenia. Read more about this study

Who is it for?
Ages 20 to 60 years
Conditions the study is for
Schizophrenia
What is being tested?
Paliperidone extended-release and Risperidone immediate-release
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
17 participants
Where
3 sitesTaiwan
Study dates
Jan 2013to Jun 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 20 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Diagnosed with schizophrenia
  • Cognitive abilities screening instrument C-2.0 total score between 50 and 85 (inclusive) at baseline
  • Baseline positive and negative syndrome scale score between 60 and 85 (inclusive)
  • Clinical global impression-severity change less than or equal to 1 in the month prior to randomization
  • Patients on a stable therapeutic dose of oral risperidone IR (between 3-6 mg/day) for at least 4 weeks prior to randomization

Who cannot join

  • Treatment refractory patients, defined as failure of more than or equal to 2 adequate trials of second generation antipsychotic treatment for schizophrenia
  • History of neuroleptic malignant syndrome
  • Allergy or hypersensitivity to risperidone or paliperidone, or to any of the excipients of oral risperidone IR or paliperidone ER tablets
  • Participants who have taken paliperidone ER in the past
  • Participants who have been treated with clozapine or any long-acting injectable (depot) antipsychotic within 3 months before randomization

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Study site

    Bali Township, Taipei County

  • Study site

    Hualien City

  • Study site

    Kaohsiung City

Other trials in Taiwan

About this study

Official title: A Randomized, Open-Label, Study To Evaluate The Effect of Oral Paliperidone Extended-Release and Oral Risperidone Immediate-Release on Selected Cognitive Domains in Clinically Stable Subjects With Schizophrenia

The purpose of this study is to compare the effect of oral paliperidone extended-release and oral risperidone immediate-release on cognitive function, especially the category fluency of Cognitive Abilities Screening Instrument, Chinese version (CASI C-2.0), in patients with an established diagnosis of schizophrenia.

Read the detailed description

This is a 28-week, randomized (the study medication is assigned by chance), open-label (all people know the identity of the intervention), active-controlled (patients are assigned to either a recognized effective treatment or the study medication) comparative study. All patients will enter a run-in period to receive a stable therapeutic dose of oral risperidone immediate-release for at least 4 weeks. After the 4-week run-in period, patients will be randomly assigned to either remain on oral risperidone immediate-release (IR) or to receive a therapeutic dose of oral paliperidone extended-release (ER) and patients will be prospectively followed for a 24-week treatment phase. The treatment phase is composed of a 4-week flexible dose period followed by a 20-week stable dose period. During the 4-week flexible dose period, the dose of paliperidone ER or risperidone IR may be increased or decreased for each patient if clinically indicated (eg, significant side effects emerge or there is evidence of a lack of efficacy). At the end of 4-week flexible dose period, the final dose should be maintained for the 20-week fixed-dose period. Efficacy and safety will be assessed at baseline (Week 0) and Weeks 4, 12, and 24.

Conditions
Schizophrenia
Being tested
Paliperidone extended-release, Risperidone immediate-release
Keywords
Schizophrenia, Paliperidone, Risperidone, Paliperidone extended-release (ER), Risperidone immediate-release (IR)
Medical subject headings
Schizophrenia

What participants receive

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

  • Paliperidone extended-releaseDrug

    Also called Paliperidone

    Patients will receive 6 mg to 12 mg of paliperidone extended-release tablet once daily orally.

  • Risperidone immediate-releaseDrug

    Also called Risperidone IR

    Patients will receive 3 mg to 7 mg of risperidone immediate-release tablet orally.

Study groups in NCT01670071
Study groupRoleWhat they receive
Paliperidone extended-releaseExperimentalNot described
Receives: Drug: Paliperidone extended-release
Risperidone immediate-releaseActive comparatorNot described
Receives: Drug: Risperidone immediate-release

What is being measured

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

  1. Change in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24

    CASI C-2.0 will be used to measure patient's cognitive ability. The range of CASI score is 0 to 100 (a higher score indicating better performance and is influenced by patient's educational level). The CASI C-2.0 provides quantitative assessment on 9 cognitive domains and 20 questions, including attention, concentration, orientation, short-term memory, long-term memory, language abilities, visual construction, category fluency, abstraction, and judgment.

    Measured: Baseline (Week 0), Week 4, Week 12 and Week 24

Secondary outcomes (6)

  1. Change from baseline to Week 24 in score of Modified Wisconsin Card Sorting Test (MWCST) short version

    The WCST was developed to assess abstract reasoning and ability to shift cognitive strategies in response to environmental changes. The materials consist of a pack of 4 stimulus cards and 48 response cards which are devised so that each card contains from 1 to 4 identical figures of a single color. Individually administered, it requires the patient to sort the cards according to different principles (ie, by color, form, or number). As the test progresses, there are unannounced shifts in the sorting principle which require the patient to alter his or her approach.

    Measured: Baseline, Week 4, Week 12 and Week 24

  2. Change from baseline in score of Continuous Performance Test (CPT)

    CPT is an attention test. Response patterns on the CPT II is used as an aid in monitoring treatment effectiveness. For example, some response patterns suggest inattentiveness or impulsivity, while other response patterns may indicate activation/arousal problems or difficulties maintaining vigilance.

    Measured: Baseline, Week 4, Week 12 and Week 24

  3. Change from baseline in score of Personal and Social Performance (PSP) scale

    The PSP is a clinician-rated instrument providing an overall rating of personal and social functioning in subjects with schizophrenia on a scale of 1-100. 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 4, Week 12 and Week 24

  4. Change from baseline in score 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, which provides a total score (sum of the scores of all 30 items). Each scale is rated 1 (absent) to 7 (extreme).

    Measured: Baseline, Week 4, Week 12 and Week 24

  5. Change from baseline in score 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 ranging from 1 (not ill) to 7 (extremely severe). This scale permits a global evaluation of the patient's condition at a given time.

    Measured: Baseline, Week 4, Week 12 and Week 24

  6. Change from baseline in score of Medication Satisfaction Questionnaire (MSQ)

    MSQ is designed to assess treatment satisfaction among patients with schizophrenia. It consists of 1 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, and 7=extremely satisfied.

    Measured: Baseline, Week 4, Week 12 and Week 24

Timeline

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

  1. First posted21 Aug 2012 (estimated)
  2. Study startJan 2013
  3. Primary completionJun 2015
  4. Study completionJun 2015

Why it stopped: The study was terminated due to insufficient sample size and protocol compliance issue.

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
17 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01670071
Sponsor's protocol ID
CR100817
Other IDs
R076477SCH4066
Status last verified
Apr 2016
First submitted
17 Aug 2012
Last updated
13 Apr 2016
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paliperidone extended-release and Risperidone immediate-release in people with Schizophrenia, run by Johnson & Johnson Taiwan Ltd at 3 sites 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 5 inclusion and 5 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 13 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites 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 was stopped early (reason given: The study was terminated due to insufficient sample size and protocol compliance issue.). 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 in category fluency score of cognitive function scale (Cognitive Abilities Screening Instrument, Chinese version [CASI C-2.0]) from baseline to Week 24 (time frame: Baseline (Week 0), Week 4, Week 12 and Week 24). 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 NCT01670071.

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 13 Apr 2016.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in