SchizophreniaPhase 3NCT01606228
A Trial to Explore the Tolerability, Safety and Efficacy of Paliperidone Extended Release in Patients 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 tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- 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
- 188 participants
- Where
- No sites listed yet
- Study dates
- Dec 2007to Dec 2008
- 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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients diagnosed with schizophrenia
- Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
- Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
- Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
- Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
Who cannot join
- Serious unstable medical condition, including known clinically relevant laboratory abnormalities
- 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 (patients may not chew, divide, dissolve, or crush the study medication)
- Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
- Patients with a current use or known history (over the past 6 months) of substance dependence
- Positive urine drug examination
About this study
Official title: An Open-Label Prospective Trial to Explore the Tolerability, Safety and Efficacy of Flexibly-Dosed Paliperidone ER Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
The purpose of this study is to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
Read the detailed description
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Paliperidone ER, Treatment naive patients, Newly diagnosed patients
- 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
Type= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone 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.
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Measured: Baseline, Day 90
Secondary outcomes (11)
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Measured: Baseline
Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
Measured: Day 90
Clinical Global Impression-Severity (CGIS) Scores at Baseline
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Measured: Baseline
Clinical Global Impression-Severity (CGIS) Scores at Day 90
The CGI-S rating scale is a 7 point global assessment that measures the clinician's impression of the severity of illness exhibited by a patient. The rating varies from "Normal (not at all ill)" to "Extreme (among the most extremely ill patients)".
Measured: Day 90
Personal and Social Performance (PSP) Scores at Baseline
This PSP assesses the degree of a patient's 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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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
Personal and Social Performance (PSP) Scores at Day 90
This PSP assesses the degree of a patient's 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 (i, absent to vi, very severe) in each of the 4 domains. Based on the four domains there will be one total score. Patients 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: Day 90
Patient Satisfaction With Paliperidone Treatment
Patients will be interviewed to assess their satisfaction with the current treatment on a 5-point scale (very good, good, reasonable, moderate or poor).
Measured: 90 days
Quality of Sleep at Baseline
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Measured: Baseline
Quality of Sleep at Day 90
The quality of sleep is measured by a self-administered scale in which patients indicate how well they have slept in the previous 7 days, from 0 (very badly) to 100 (very well).
Measured: Day 90
Daytime Drowsiness at Baseline
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Measured: Baseline
Daytime Drowsiness at Day 90
The daytime drowsiness is measured by a self-administered scale in which patients indicate how often they have felt drowsy within the previous 7 days, from 0 (not at all) to 100 (all the time).
Measured: Day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2012 (estimated)
- Study startDec 2007
- Primary completionDec 2008
- Study completionDec 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 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 188 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Janssen Pharmaceutica Clinical Trial, Study director, Janssen Pharmaceutica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01606228
- Sponsor's protocol ID
- CR014452
- Other IDs
- R076477SCH3033, PAL-PHL-MA3
- Status last verified
- Sep 2012
- First submitted
- 16 May 2012
- Last updated
- 22 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2012. 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 Among Treatment-Naïve and Newly Diagnosed Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01606228
- Acronym / sponsor ID
- CR014452
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone ER, Treatment naive patients, Newly diagnosed patients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 188 participants (actual)
- Lead sponsor
- Janssen PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Dec 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 25 May 2012 (estimated)
- Results
- Posted 22 Oct 2012
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 tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among patients with schizophrenia.
Detailed description
This is a single arm (the same intervention is given to all patients), multicenter study that aimed to explore the tolerability, safety and efficacy of flexibly dosed paliperidone extended release (ER) among Filipino patients with schizophrenia who have not taken any antipsychotics in the past, and among newly diagnosed schizophrenia patients who have not taken any antipsychotics for at least one month prior to screening. Antipsychotics are drugs that are helpful in the treatment of psychosis and have a capacity to ameliorate thought disorders. Flexible dosing allows the investigators to adjust the dosage of each patient based on the individual needs.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Paliperidone ER | Experimental | Drug: Paliperidone ER |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients diagnosed with schizophrenia
- Patient with Positive and Negative Syndrome Scale (PANSS) score of 80 to 120 at screening
- Patients who have not taken any antipsychotics in the past, and those were newly diagnosed with schizophrenia who have not taken any antipsychotics for at least one month prior to screening
- Patient healthy on the basis of a physical examination, laboratory examination, and vital signs
- Women must have a negative pregnancy test, and agree to practice an effective method of birth control before entry and throughout the study
Key exclusion criteria (6 listed)
- Serious unstable medical condition, including known clinically relevant laboratory abnormalities
- 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 (patients may not chew, divide, dissolve, or crush the study medication)
- Biochemistry results that are out of the laboratory's normal reference range and are deemed to be clinically significant by the investigator
- Patients with a current use or known history (over the past 6 months) of substance dependence
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 ERType= range, unit= mg/day, number= 3 to 12, form= tablet, route= oral use. Paliperidone ER 6 mg orally administered once daily for the first five days. Thereafter, flexible dosing in a range of 3 to 12 mg/day. | Drug | Paliperidone ER |
Primary outcome
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90)
Time frame: Baseline, Day 90
The PANSS is a 30-item scale (range 30-210) 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. Higher scores indicate worsening.
11 secondary outcomes
Positive and Negative Syndrome Scale (PANSS) Scores at Baseline
Time frame: Baseline
Positive and Negative Syndrome Scale (PANSS) Scores at Day 90
Time frame: Day 90
Clinical Global Impression-Severity (CGIS) Scores at Baseline
Time frame: Baseline
Clinical Global Impression-Severity (CGIS) Scores at Day 90
Time frame: Day 90
Personal and Social Performance (PSP) Scores at Baseline
Time frame: Baseline
Personal and Social Performance (PSP) Scores at Day 90
Time frame: Day 90
Patient Satisfaction With Paliperidone Treatment
Time frame: 90 days
Quality of Sleep at Baseline
Time frame: Baseline
Quality of Sleep at Day 90
Time frame: Day 90
Daytime Drowsiness at Baseline
Time frame: Baseline
Daytime Drowsiness at Day 90
Time frame: Day 90
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2012.
- 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 6 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 22 Oct 2012. 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 22 Oct 2012). 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?
The Proportion of Patients Improving 20% in Total Positive and Negative Syndrome Scale (PANSS) at Endpoint (Day 90) (time frame: Baseline, Day 90). 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 22 Oct 2012.