Symptomatic Remission and Social Function in Participants Treated With Paliperidone Extended Release (ER)

A Phase 4 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Taiwan Ltd.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to explore the relationship between achieving symptomatic remission status by means of the 8 items of Positive and Negative Syndrome Scale (PANSS), and personal and social functioning by means of the Personal and Social Performance (PSP) scale in participants treated with flexibly dosed… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Schizophrenia
What is being tested?: Paliperidone ER
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 480 participants
Where: No sites listed yet
Study dates: Jul 2008to Jun 2009
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study
Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening

Who cannot join

Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Participants with known hypersensitivity to paliperidone ER or risperidone
Participants with inability to swallow the whole study medication tablet with aid of water

About this study

Official title: Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER

Read the detailed description

This is an open label (all people know the identity of the intervention), multicenter (when more than one hospital or medical school team work on a medical research study) and prospective (study following participants forward in time) 12-week study. Participants can be either in- or outpatients. The total study duration will be 12 weeks for each participant and will include following visits: Screening, Week 0, 4, 8, and 12 (end of treatment or early withdrawal). Throughout the study, participants will receive paliperidone ER in a flexible dosing range of 3 to 12 milligram per day (mg/day). Efficacy will primarily be evaluated by PANSS and PSP scale. Participants' safety will also be monitored throughout the study.

Conditions: Schizophrenia
Being tested: Paliperidone ER
Keywords: Schizophrenia, Paliperidone Extended Release
Medical subject headings: Schizophrenia

What participants receive

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

Paliperidone ERDrug
Participants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.

Study groups in NCT01577186
Study group	Role	What they receive
Paliperidone Extended Release (ER)	Experimental	Not described Receives: Drug: Paliperidone ER

What is being measured

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

Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Measured: End of study (Up to Week 12)
Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Measured: End of study (Up to Week 12)

Secondary outcomes (1)

Social Functioning Scale (SFS) Score
The SFS is a 36-item scale designed to assess social functioning in schizophrenia. It assesses abilities and performance in seven areas: social engagement, interpersonal communication, activities of daily living, recreation, social activities, competence at independent living, and occupation/employment. Total score ranges from 1 to 100 where higher score indicates a more favorable health state.
Measured: End of study (Up to Week 12)

Timeline

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

Jul 2008Jun 2009

First posted13 Apr 2012 (estimated)
Study startJul 2008
Primary completionJun 2009
Study completionJun 2009

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 480 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01577186
Sponsor's protocol ID: CR015667
Other IDs: R076477SCH4035, PAL-TWN-MA3
Status last verified: Dec 2013
First submitted: 12 Apr 2012
Last updated: 17 Jan 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 17 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Symptomatic Remission and Social Function in Patients Treated With Paliperidone ER
ClinicalTrials.gov ID: NCT01577186
Acronym / sponsor ID: CR015667
Conditions: Schizophrenia
Keywords: Schizophrenia, Paliperidone Extended Release
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 480 participants (actual)
Lead sponsor: Johnson & Johnson Taiwan LtdIndustry (pharma, biotech, devices)
Study start: Jul 2008
Primary completion: Jun 2009 (actual)
Study completion: Jun 2009 (actual)
First posted: 13 Apr 2012 (estimated)
Results: Posted 17 Jan 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Paliperidone Extended Release (ER)	Experimental	Drug: Paliperidone ER

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Participants who meet the Diagnostic and Statistical Manual of Mental Disorders, 4th edition (DSM-IV) criteria for schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self)
Participant is drug naive or participant's previous treatment is considered unsuccessful due to one or more of the following reasons: lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons
Participants or their legally acceptable representatives had signed an informed consent document indicating that they understand the purpose of and procedures required for the study and were willing to participate in the study
Women must be postmenopausal for at least 1 year, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study and must have a negative urine pregnancy test at screening

Key exclusion criteria (5 listed)

Participants with use of clozapine, paliperidone extended release (ER), any conventional depot neuroleptic or Risperdal CONSTA during the last 3 months
Participants with serious unstable medical condition, including known clinically relevant laboratory abnormalities
Participants with history of neuroleptic malignant syndrome (high fever, rigid muscles, shaking, confusion, sweating more than usual, increased heart rate or blood pressure, or muscle pain or weakness)
Participants with known hypersensitivity to paliperidone ER or risperidone
Participants with inability to swallow the whole study medication tablet with aid of water

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 ERParticipants will receive paliperidone ER tablet in flexible dose range of 3 to 12 milligram per day (mg/day) orally once daily up to Week 12 as per Investigator's discretion.	Drug	Paliperidone Extended Release (ER)

Primary outcome

Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)
Time frame: End of study (Up to Week 12)
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self). The PANSS provides a total score and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each item scored on a scale of 1 (absent), 2 (minimal), 3 (mild), 4 (moderate), 5 (moderately severe), 6 (severe) and 7 (extreme). The total score ranges from 30 to 210 and higher score indicates greater severity. Symptomatic remission was defined as achieving intensity level of mild or moderate on PANSS scale by all 8 items as the determinants for symptomatic remission: delusions, unusual thought content, hallucinatory behavior, conceptual disorganization, mannerisms/posturing, blunted affect, social withdrawal, lack of spontaneity.
Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale
Time frame: End of study (Up to Week 12)
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.

1 secondary outcome

Social Functioning Scale (SFS) Score
Time frame: End of study (Up to Week 12)

Results and safety

Results posted to the registry on 17 Jan 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Paliperidone ER	480	350

Primary outcome: Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS)

Time frame: End of study (Up to Week 12). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Paliperidone Extended Release (ER) n = 426
Value	11.74 (8.84 to 15.18)

Population analysed: Intent-to-treat (ITT) population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.

Primary outcome: Percentage of Participants Achieving Improvement in Personal and Social Performance (PSP) Score by at Least One Category on PSP Scale

Time frame: End of study (Up to Week 12). Number (95% Confidence Interval). Unit: percentage of participants

Measure	Paliperidone Extended Release (ER) n = 426
Value	47.42 (42.59 to 52.28)

Population analysed: ITT population included all participants who received at least 1 dose of study drug and had at least one post-baseline assessment.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: 12 weeks. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Paliperidone ER	37 of 480 (7.7%)	169 of 480 (35.2%)	Not reported

Limitations and caveats (from the sponsor): Some Adverse Events summaries were reported based on estimates due to the fact that they were not prepared in the original study report and the relevant definitions of the data elements were not available for these summaries to be regenerated.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Schizophrenia

RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
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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.

Johnson & Johnson Taiwan Ltd Clinical Trial study director

Johnson & Johnson Taiwan Ltd

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Paliperidone ER in people with Schizophrenia, run by Johnson & Johnson Taiwan Ltd.

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 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: finished, as of the sponsor's last update on 17 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.

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?

Yes. Results are posted in the registry (first posted 17 Jan 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percentage of Participants Achieving Symptomatic Remission by Means of Positive and Negative Syndrome Scale (PANSS) (time frame: End of study (Up to Week 12)). The study lists 2 primary outcomes in all. 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 NCT01577186.

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 17 Jan 2014.