SchizophreniaPhase 4NCT01726335

Switching From Oral Antipsychotics to Long-Acting Risperidone in Participants With Schizophrenia

A Phase 4 study testing Risperidone prolonged release in people with Schizophrenia, run by Janssen-Cilag Ltd. at 5 sites in Brazil.

Completed

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

Official record

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Trial summary

The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Schizophrenia
What is being tested?: Risperidone prolonged release
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 53 participants
Where: 5 sitesBrazil
Study dates: Jan 2006to Mar 2008
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 to 50 years
All sexes
No healthy volunteers
Adult

Who may be able to join

Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
Be not pregnant as showed on negative pregnancy serum test

Who cannot join

Contraindication or known hypersensitivity to risperidone
Previous history of unsatisfactory response to risperidone
Previous history of refractivity to the other second generation antipsychotics
Use of antipsychotic of intramuscular deposit in the last 12 months
Other mental disturbances of DSM-IV axis

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

Brazil5 sites

Study site
Curitiba
Study site
Porto Alegre
Study site
Rio de Janeiro
Study site
Salvador
Study site
São Paulo

Other trials in Brazil

About this study

Official title: An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment

Read the detailed description

This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Conditions: Schizophrenia
Being tested: Risperidone prolonged release
Keywords: Schizophrenia, Risperidone, Risperdal consta
Medical subject headings: Schizophrenia

What participants receive

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

Risperidone prolonged releaseDrug
Also called - Risperdal consta
Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Study groups in NCT01726335
Study group	Role	What they receive
Risperidone prolonged release	Experimental	Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3. Receives: Drug: Risperidone prolonged release

What is being measured

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

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 2
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 4
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 8
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 16
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 24
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 38
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Week 50

Secondary outcomes (6)

Clinical Global Impressions (CGI) - Disease Severity Score
The CGI rating scale is a 7-point global assessment that measures the clinician's impression of the severity of illness exhibited by a participant. A rating of 1 indicates to "normal, not at all ill" and a rating of 7 indicates "among the most extremely ill participants". Higher scores indicate worsening.
Measured: Baseline and Week 2, 4, 8, 16, 24, 38 and 50
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
The ESRS is used to assess four types of drug-induced movement disorders administered as a questionnaire. Score range from 0 to 6 (0 is absent and 6 is extremely severe).
Measured: Baseline and Week 2, 4, 8, 16, 24 and 50
Drug Attitude Inventory (DAI-10)
The DAI-10 is a 10-item questionnaire to assess 1) subjective experience of drug and 2) attitudes and beliefs toward neuroleptics which may influence compliance in schizophrenia participants. It is the binary scale assessing the participant's subjective response. A 'compliant' response is scored as +1; a dysphoric response is scored as -1. A positive sum of items indicates a positive subjective response (SR); a negative sum of scores indicates a negative SR (non-compliant). The final score is the grand total of the positive and negative points. Total score ranges from (-) 10 to (+) 10, higher score indicates positive SR (compliant) and lower score indicates negative SR (non-compliant).
Measured: Screening, and Week 8, 24 and 50
Short Form-36 (SF-36) - Quality of Life
The SF-36 is a survey of participant health. It consists of eight scaled scores, which are the weighted sums of the questions in their section. The eight sections are: vitality, physical functioning, bodily pain, general health perceptions, physical role functioning, emotional role functioning, social role functioning, and mental health. Each item is scored on a 0-100 range so that the lowest and highest possible scores are set at 0 and 100, respectively. All items are scored so that a high score defines a more favorable health state.
Measured: Baseline and Week 50
Personal and Social Performance (PSP) Scale Score
The PSP scale assesses the degree of a participant's dysfunction (ranging from i [absent] to vi [very severe) within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behavior. The overall score ranges from 1 to 100. Based on the 4-domains there was one total score. Participants with a score of 71 to 100 had a mild degree of difficulty; from 31 to 70, varying degrees of disability; participants with scores of 30 or less function so poorly as to require intensive supervision.
Measured: Screening, and Week 8, 16, 24, 38 and 50
Global Assessment of Functioning (GAF) Scale Score
The GAF scale is a 100-point tool rating overall psychological, social and occupational functioning of adults. The higher score range (91-100) refers to a superior functioning in a wide range of activities, and absence of symptoms. The lower score range (1-10) refers to persistent danger of severely hurting self or others; or persistent inability to maintain minimum personal hygiene; or serious suicidal act with clear expectation of death.
Measured: Screening, and Week 8, 16, 24, 38 and 50

Timeline

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

Jan 2006Mar 2008

First posted14 Nov 2012 (estimated)
Study startJan 2006
Primary completionMar 2008
Study completionMar 2008

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: 53 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01726335
Sponsor's protocol ID: CR012484
Other IDs: RISSCH4135
Status last verified: Apr 2014
First submitted: 9 Nov 2012
Last updated: 29 Apr 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?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open-Label Study of Oral Antipsychotics Replacement by Prolonged Release Risperidone (Risperdal Consta) in Schizophrenic Subjects With Bad Adhesion to the Treatment
ClinicalTrials.gov ID: NCT01726335
Acronym / sponsor ID: CR012484
Conditions: Schizophrenia
Keywords: Schizophrenia, Risperidone, Risperdal consta
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 53 participants (actual)
Lead sponsor: Janssen-Cilag Ltd.Industry (pharma, biotech, devices)
Study start: Jan 2006
Primary completion: Mar 2008 (actual)
Study completion: Mar 2008 (actual)
First posted: 14 Nov 2012 (estimated)
Results: Posted 24 Jul 2013

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
Risperidone prolonged release	Experimental	Drug: Risperidone prolonged releaseRisperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

Have schizophrenia diagnosis by Diagnostic and Statistical Manual of Mental Disorders, fourth edition (DSM-IV)
Be on treatment with oral antipsychotic of first or second generation, for a minimum time of 12 months
Previous history of bad adhesion to oral antipsychotic treatment in the last 12 months
Total Positive and Negative Syndrome Scale score less than or equal to 90, the conceptual disorganization, hallucinatory behavior, suspicion and not usual content of thought must be less than or equal to 4
Be not pregnant as showed on negative pregnancy serum test

Key exclusion criteria (5 listed)

Contraindication or known hypersensitivity to risperidone
Previous history of unsatisfactory response to risperidone
Previous history of refractivity to the other second generation antipsychotics
Use of antipsychotic of intramuscular deposit in the last 12 months
Other mental disturbances of DSM-IV axis

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
Risperidone prolonged releaseAlso: - Risperdal constaRisperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.	Drug	Risperidone prolonged release

Primary outcome

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2
Time frame: Week 2
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4
Time frame: Week 4
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8
Time frame: Week 8
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16
Time frame: Week 16
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 24
Time frame: Week 24
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 38
Time frame: Week 38
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Positive and Negative Syndromes Scale (PANSS) Total Score at Week 50
Time frame: Week 50
The PANSS is a 30-item scale designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The 30 symptoms are rated on a 7-point scale that ranges from 1 (absent) to 7 (extreme psychopathology). The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

6 secondary outcomes

Clinical Global Impressions (CGI) - Disease Severity Score
Time frame: Baseline and Week 2, 4, 8, 16, 24, 38 and 50
Extrapyramidal Symptoms Rating Scale (ESRS) Total Score
Time frame: Baseline and Week 2, 4, 8, 16, 24 and 50
Drug Attitude Inventory (DAI-10)
Time frame: Screening, and Week 8, 24 and 50
Short Form-36 (SF-36) - Quality of Life
Time frame: Baseline and Week 50
Personal and Social Performance (PSP) Scale Score
Time frame: Screening, and Week 8, 16, 24, 38 and 50
Global Assessment of Functioning (GAF) Scale Score
Time frame: Screening, and Week 8, 16, 24, 38 and 50

Results and safety

Results posted to the registry on 24 Jul 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Risperidone Prolonged Release	53	29

Primary outcome: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2

Time frame: Week 2. Mean (Standard Error). Unit: Units on a scale

Measure	Risperidone Prolonged Release n = 51
Value	55.53 (1.82)

Population analysed: Intent-to-treat-efficacy evaluation (ITTe) population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.

Primary outcome: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 4

Time frame: Week 4. Mean (Standard Error). Unit: Units on a scale

Measure	Risperidone Prolonged Release n = 51
Value	53.82 (1.83)

Population analysed: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.

Primary outcome: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 8

Time frame: Week 8. Mean (Standard Error). Unit: Units on a scale

Measure	Risperidone Prolonged Release n = 51
Value	51.28 (1.86)

Population analysed: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.

Primary outcome: Positive and Negative Syndromes Scale (PANSS) Total Score at Week 16

Time frame: Week 16. Mean (Standard Error). Unit: Units on a scale

Measure	Risperidone Prolonged Release n = 51
Value	50.55 (1.98)

Population analysed: The ITTe population included all the Participants who received at least one dose of study medication and provided one measure post-baseline of efficacy.

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline up to Week 50. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Risperidone Prolonged Release	3 of 53 (5.7%)	40 of 53 (75.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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-Cilag Ltd. Clinical trial study director

Janssen-Cilag Ltd.

5 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 Risperidone prolonged release in people with Schizophrenia, run by Janssen-Cilag Ltd. at 5 sites in Brazil.

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: finished, as of the sponsor's last update on 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in Brazil. 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?

Yes. Results are posted in the registry (first posted 24 Jul 2013). 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?

Positive and Negative Syndromes Scale (PANSS) Total Score at Week 2 (time frame: Week 2). The study lists 7 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 NCT01726335.

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 29 Apr 2014.