SchizophreniaPhase 3NCT01662648
Safety, Efficacy and Tolerability Study of Paliperidone Extended-Release (ER) in Participants With Schizophrenia
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Janssen Pharmaceutica.
Trial summary
The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously… 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
- 1,117 participants
- Where
- No sites listed yet
- Study dates
- Jun 2007to Apr 2009
- Phase
- Phase 3
- 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
- Participant diagnosed with schizophrenia
- Participant's previous treatment of schizophrenia is considered unsuccessful
- Participant is healthy on the basis of a physical examination and vital signs
- Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- Be willing and able to fill out self-administered questionnaires
Who cannot join
- Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- Judged to be at high risk for adverse events, violence or self-harm
- Inability to swallow the study medication whole with the aid of water
- Pregnant or breast-feeding female
- History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
About this study
Official title: An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
The purpose of this study is to explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.
Read the detailed description
This is a single arm (one group of participants), multi-center, 6-month study to explore the tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication. Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the participant was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout the study the investigators will adjust the dosage of each participant based on the individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once daily. Participants can be either in- or outpatients and they may take their study drug with or without food. Participants who will complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Paliperidone, Paliperidone extended-release (ER)
- 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
Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone ER: Lack of efficacy | Experimental | Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. Receives: Drug: Paliperidone ER |
| Paliperidone ER: Lack of tolerability, compliance or other | Experimental | Paliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons. Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
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. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Secondary outcomes (8)
Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
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. Percentage of participants with greater than or equal to 20 % improvement in PANSS total score is reported here. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Week 26
Change From Baseline in PANSS Total Positive Subscale Score at Week 26
The Positive Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven positive-symptoms of schizophrenia. Positive symptoms refer to an excess of or distortion of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Change From Baseline in PANSS Total Negative Subscale Score at Week 26
The Negative Subscale of PANSS (Positive and Negative Syndrome Scale) assesses seven negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, ranging from 7 (absent) to 49 (extreme psychopathology). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
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. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
The PSP scale assesses the degree of dysfunction 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 (1, absent to 6, very severe) in each of the 4 domains. Participants with a score of 71 to 100 have a mild degree of difficulty; from 31 to 70, varying degrees of disability; less or equal to 30, functioning so poorly as to require intensive supervision. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Change From Baseline in Sleep Quality at Week 26
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how well they have slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Change From Baseline in Daytime Drowsiness at Week 26
Daytime Drowsiness was assessed by an 11-point visual analog scale that rates how well participants sleep. Participants indicated on the scale (from 0 to 100 millimeter) how often they have felt drowsy within the previous 7 days (from 0: "not at all" to 100:"all the time"). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Number of Participants Within Each Category of Patient Satisfaction Score
Participants were interviewed at baseline and at the end of the trial (Week 26) to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor). Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
Measured: Baseline and Week 26
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2012 (estimated)
- Study startJun 2007
- Primary completionApr 2008
- Study completionApr 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 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,117 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01662648
- Sponsor's protocol ID
- CR013534
- Other IDs
- R076477SCH3024
- Status last verified
- Apr 2014
- First submitted
- 8 Aug 2012
- Last updated
- 5 May 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly Dosed Paliperidone ER in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT01662648
- Acronym / sponsor ID
- CR013534
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Paliperidone extended-release (ER)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,117 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Apr 2008 (actual)
- Study completion
- Apr 2009 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 26 Mar 2014
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 explore the efficacy of flexibly dosed paliperidone extended-release (ER) in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self) who were previously unsuccessfully treated with other oral antipsychotics.
Detailed description
This is a single arm (one group of participants), multi-center, 6-month study to explore the tolerability, safety and efficacy of flexibly dosed paliperidone ER in participants with schizophrenia previously unsuccessfully treated with an oral antipsychotic medication. Antipsychotic medications are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Unsuccessfully treated means that, despite the participant was treated with an adequate dose of an appropriate oral antipsychotic for an adequate period of time, previous treatment is considered unsuccessful due to lack of efficacy, lack of tolerability or safety, lack of compliance and/or other reasons. Throughout the study the investigators will adjust the dosage of each participant based on the individual needs. In general, the recommended paliperidone ER dose will be 6 milligram once daily. Participants can be either in- or outpatients and they may take their study drug with or without food. Participants who will complete this 6-month study and would like to continue will be eligible to be enrolled in an extension phase until paliperidone ER is available.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone ER: Lack of efficacy | Experimental | Drug: Paliperidone ERPaliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of efficacy. |
| Paliperidone ER: Lack of tolerability, compliance or other | Experimental | Drug: Paliperidone ERPaliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion to participants who transitioned to Paliperidone ER from other oral antipsychotics for the main reason of lack of tolerability, compliance or other reasons. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participant diagnosed with schizophrenia
- Participant's previous treatment of schizophrenia is considered unsuccessful
- Participant is healthy on the basis of a physical examination and vital signs
- Women must be postmenopausal, surgically sterile, abstinent, or, if sexually active, agree to practice an effective method of birth control before entry and throughout the study
- Be willing and able to fill out self-administered questionnaires
Key exclusion criteria (5 listed)
- Have used clozapine or Risperdal CONSTA during the last month, or have received any other conventional drug used to treat psychosis during the last 3 months
- Judged to be at high risk for adverse events, violence or self-harm
- Inability to swallow the study medication whole with the aid of water
- Pregnant or breast-feeding female
- History or current symptoms of tardive dyskinesia (involuntary movements of the facial muscles and tongue)
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 ERPaliperidone extended-release (ER) tablet in dose range of 3 to 12 milligram (mg) per day will be given orally for 6 months as per Investigator's discretion. | Drug | Paliperidone ER: Lack of efficacy, Paliperidone ER: Lack of tolerability, compliance or other |
Primary outcome
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26
Time frame: Baseline and Week 26
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. Data for two groups is presented here, based on the reason to switch: lack of efficacy and lack of tolerability, compliance or other who switched from other previous antipsychotic drugs to paliperidone.
8 secondary outcomes
Percentage of Participants With Greater Than or Equal to 20 Percent (%) Improvement in PANSS Total Score at Week 26
Time frame: Week 26
Change From Baseline in PANSS Total Positive Subscale Score at Week 26
Time frame: Baseline and Week 26
Change From Baseline in PANSS Total Negative Subscale Score at Week 26
Time frame: Baseline and Week 26
Change From Baseline in Clinical Global Impression-Severity (CGI-S) Score at Week 26
Time frame: Baseline and Week 26
Change From Baseline in Personal and Social Performance (PSP) Scale at Week 26
Time frame: Baseline and Week 26
Change From Baseline in Sleep Quality at Week 26
Time frame: Baseline and Week 26
Change From Baseline in Daytime Drowsiness at Week 26
Time frame: Baseline and Week 26
Number of Participants Within Each Category of Patient Satisfaction Score
Time frame: Baseline and Week 26
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 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 Pharmaceutica Clinical Trial study director
Janssen Pharmaceutica
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone ER in people with Schizophrenia, run by Janssen Pharmaceutica.
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 5 May 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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 26 Mar 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?
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 26 (time frame: Baseline and Week 26). 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 5 May 2014.