SchizophreniaPhase 3NCT01009047
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
A Phase 3 study testing Paliperidone extended release (ER) and Aripiprazole in people with Schizophrenia, run by Janssen Research & Development, LLC at 41 sites in 7 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality… Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone extended release (ER) and Aripiprazole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 228 participants
- Where
- 41 sitesin 7 countries
- Study dates
- Dec 2009to Jun 2012
- 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 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
- Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening
- Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
- Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
- Participants with a weight of equal to or greater than 29 kilogram
Who cannot join
- Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
- Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening
- Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
- Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit
- Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)
Trial locations and contacts
41 sites in 7 countries.
41 sites in 7 countries
Russia13 sites
Study site
Chelyabinsk
Study site
Ekaterinburg Na
Study site
Krasnodar
Study site
Moscow
Study site
Moscow Russia
Study site
Nizhny Novgorod
Study site
Novosibirsk
Study site
Saint Petersburg
Study site
Samara
Study site
Saratov
Study site
Smolensk Region N/A
Study site
Tomsk Na
Study site
Yaroslavl
Ukraine8 sites
Study site
Donetsk
Study site
Hlevakha
Study site
Ivano-Frankivsk
Study site
Kharkiv
Study site
Kherson
Study site
Kiev
Study site
Poltava
Study site
Simferopol
Spain7 sites
Study site
Badajoz
Study site
Esplugues de Llobregat
Study site
Madrid
Study site
Paterna
Study site
Sabadell
Study site
Seville
Study site
Valladolid
United States6 sites
Study site
Atlanta, Georgia
Study site
Dothan, Alabama
Study site
Lake Charles, Louisiana
Study site
Santa Ana, California
Study site
Shreveport, Louisiana
Study site
Smyrna, Georgia
India5 sites
Study site
Jaipur
Study site
Kanpur Uttarpradeh
Study site
Lucknow Gpo
Study site
Mangalore
Study site
Varanasi
About this study
Official title: A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age
The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .
Read the detailed description
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone extended release (ER), Aripiprazole
- Keywords
- Schizophrenia, Paliperidone, Aripiprazole
- 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 release (ER)Drug
Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
AripiprazoleDrug
Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone extended-release (ER) | Experimental | Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. Receives: Drug: Paliperidone extended release (ER) |
| Aripiprazole | Active comparator | Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. Receives: Drug: Aripiprazole |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
Measured: Baseline and Day 56
Secondary outcomes (8)
Change From Baseline in PANSS Total Score at Day 182
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: Baseline and Day 182
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
Measured: Baseline, Day 56 and Day 182
Change From Baseline in Other Marder Factors Scores at Day 56 and 182
The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.
Measured: Baseline, Day 56 and 182
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).
Measured: Baseline, Day 56 and 182
Number of Participants With Clinical Stability
Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.
Measured: Day 56 and 182
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
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 participant. A rating of 1 is equivalent to "Normal, not at all ill" and a rating of 7 is equivalent to "Among the most extremely ill participants". Higher scores indicate worsening.
Measured: Baseline, Day 56 and 182
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
Measured: Baseline, Day 56 and Day 182
Number of Participants With PANSS Response
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.
Measured: Day 56 and 182
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2012
- Study completionJun 2012
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Janssen Research & Development, LLCThe sponsor's other registered studies.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 228 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Research & Development, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Research & Development, LLC Clinical Trial, Study director, Janssen Research & Development, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01009047
- Sponsor's protocol ID
- CR016675
- Other IDs
- R076477PSZ3003
- Status last verified
- Jun 2013
- First submitted
- 5 Nov 2009
- Last updated
- 21 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Savitz AJ, Lane R, Nuamah I, Gopal S, Hough D. Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. J Am Acad Child Adolesc Psychiatry. 2015 Feb;54(2):126-137.e1. doi: 10.1016/j.jaac.2014.11.009. Epub 2014 Nov 25.
PubMed 25617253
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age
- ClinicalTrials.gov ID
- NCT01009047
- Acronym / sponsor ID
- CR016675
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Aripiprazole
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 228 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 6 Nov 2009 (estimated)
- Results
- Posted 21 Jun 2013
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 evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .
Detailed description
This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone extended-release (ER) | Experimental | Drug: Paliperidone extended release (ER)Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. |
| Aripiprazole | Active comparator | Drug: AripiprazoleAripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
- Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening
- Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
- Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
- Participants with a weight of equal to or greater than 29 kilogram
Key exclusion criteria (5 listed)
- Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
- Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening
- Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
- Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit
- Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)
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 extended release (ER)Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning. | Drug | Paliperidone extended-release (ER) |
| AripiprazoleAripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning. | Drug | Aripiprazole |
Primary outcome
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
Time frame: Baseline and Day 56
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
8 secondary outcomes
Change From Baseline in PANSS Total Score at Day 182
Time frame: Baseline and Day 182
Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
Time frame: Baseline, Day 56 and Day 182
Change From Baseline in Other Marder Factors Scores at Day 56 and 182
Time frame: Baseline, Day 56 and 182
Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
Time frame: Baseline, Day 56 and 182
Number of Participants With Clinical Stability
Time frame: Day 56 and 182
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
Time frame: Baseline, Day 56 and 182
Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
Time frame: Baseline, Day 56 and Day 182
Number of Participants With PANSS Response
Time frame: Day 56 and 182
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 25617253Savitz AJ, Lane R, Nuamah I, Gopal S, Hough D. Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. J Am Acad Child Adolesc Psychiatry. 2015 Feb;54(2):126-137.e1. doi: 10.1016/j.jaac.2014.11.009. Epub 2014 Nov 25.
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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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
41 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone extended release (ER) and Aripiprazole in people with Schizophrenia, run by Janssen Research & Development, LLC at 41 sites in 7 countries.
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 21 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 41 sites in Russia, Ukraine, Spain, United States, India and 2 more countries. 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 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 21 Jun 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?
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 (time frame: Baseline and Day 56). 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 NCT01009047, which also lists 1 linked publication.
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 21 Jun 2013.