SchizophreniaPhase 3NCT01299389
An Efficacy and Safety Study of Paliperidone Palmitate in Participants With Schizophrenia
A Phase 3 study testing Paliperidone palmitate in people with Schizophrenia, run by Janssen Pharmaceutical K.K. at 56 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong… Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Paliperidone palmitate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 323 participants
- Where
- 56 sitesin 3 countries
- Study dates
- Oct 2010to May 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants meeting Diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
- Women had to be: postmenopausal (for at least 2 years), surgically sterile (had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (as judged by the investigator; per local regulations), or if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel], male partner sterilization) as local regulations permitted, before entry, and had to agree to continue to use the same method of contraception throughout the study
- A Positive and Negative Syndrome Scale (PANSS) total score at screening and at baseline (Day 1) of 60 to 120
- Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1) (Even if the participant's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the participant will be able to meet this criterion if the participant takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the participant)
- Women of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at the screening urine pregnancy test
Who cannot join
- Primary active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision Axis I diagnosis other than schizophrenia
- A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
- History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
- Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, Intralipid, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)
Trial locations and contacts
56 sites in 3 countries.
56 sites in 3 countries
Japan40 sites
Study site
Fujioka
Study site
Fujisawa
Study site
Fukui
Study site
Fukuoka
Study site
Hadano
Study site
Ichikawa
Study site
Itoman
Study site
Kanzaki
Study site
Kashihara
Study site
Kasuya
Study site
Kawasaki
Study site
Kitagunma
Study site
Kitakyushu
Study site
Kobe
Study site
Kodaira
Study site
Koshigaya
Study site
Kumagaya
Study site
Kumamoto
Study site
Kurayoshi
Study site
Kure
Study site
Kurume
Study site
Mitaka
Study site
Miyazaki
Study site
Moriguchi
Study site
Nanyō
Study site
Nishinomiya
Study site
Ohta
Study site
Okinawa
Study site
Oyabe
Study site
Sakai
Study site
Shibukawa
Study site
Takatsuki
Study site
Tamana
Study site
Tokyo
Study site
Toyama
Study site
Toyoake
Study site
Urasoe
Study site
Yatsushiro
Study site
Yokkaichi
Study site
Yokohama
South Korea9 sites
Study site
Busan
Study site
Chungcheongbuk-Do
Study site
Daegu
Study site
Deajun
Study site
Incheon
Study site
Inchun
Study site
Jeonju
Study site
Seongnam
Study site
Seoul
Taiwan7 sites
Study site
Bali Township, Taipei County
Study site
Changhua
Study site
Hualien City
Study site
Kaohsiung City
Study site
Tainan
Study site
Taipei
Study site
Taoyuan
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
The purpose of this study is to evaluate the efficacy and safety of paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self).
Read the detailed description
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (comparing the response in two groups of participants receiving different treatments), fixed-dose, multi-center (when more than one hospital or medical school team work on a medical research study) study of paliperidone palmitate in participants with schizophrenia. The study will consist of 3 periods: an up to 2-week pre-observation (screening) period, a double-blind period from Day 1 (baseline) to Week 13 (end of double-blind period) assessment, and a post-observation period starting after the Week 13 assessment to Week 21. For participants who discontinue the study before the last assessment in Week 13, the post-observation period will start after the discontinuation from double-blind period assessment with follow-up visits at 4, 8, and 12 weeks after the last injection. After completion of the double-blind period (Week 13), discontinuation of double-blind period treatment or withdrawal from the study, participants may receive treatment consistent with the usual standard of care. The total duration of the study will be 21 weeks, including the double-blind and post-observation periods. Participants will be randomly assigned to 1 of 2 treatment groups in a 1:1 ratio (intramuscular injections of either paliperidone palmitate or matching placebo). Injections of paliperidone palmitate or placebo will be given at Day 1 and at Weeks 1, 5, and 9 by a study drug manager and/or injector. For those participants receiving paliperidone palmitate, the Day 1 injection will be 150 milligram equivalent (mg eq.) paliperidone palmitate, followed by 100 mg eq. injections of paliperidone palmitate at Week 1, and 75 mg eq. injections of paliperidone palmitate at Weeks 5 and 9. Participants randomly assigned to placebo will receive injections matching the paliperidone palmitate injections on the same days. Efficacy will be assessed using Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Severity (CGI-S). Participant's safety will be monitored throughout the study.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone palmitate, Placebo
- Keywords
- Paliperidone palmitate, Schizophrenia
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone palmitateDrug
Paliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.
PlaceboDrug
Matching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone palmitate | Experimental | Not described Receives: Drug: Paliperidone palmitate |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
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 Week 13 or Early Discontinuation
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 Week 13 or early discontinuation
Secondary outcomes (6)
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation
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 and Week 13 or early discontinuation
Participants With Response to the Treatment as Per PANSS Total Score.
Participants with response were defined as those participants who shows 30 percent or more and 20 percent or more reduction in PANSS total score.
Measured: up to Week 13 or early discontinuation
Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation
The PANSS is a 30-item scale to assess the neuropsychiatric symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). Positive symptoms subscale consists of 8 items with total score range of 8-56; negative symptoms subscale and disorganized thoughts subscale, each consists of 7 items with total score range of 7-49, uncontrolled hostility/excitement subscale and anxiety/depression subscale, each consists of 4 items with total score range of 4-28, higher score indicates greater severity.
Measured: Baseline and Week 13 or early discontinuation (ED)
Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation
Negative Syndrome Scale (range 7-49): Sum of scores for items 1-7 in negative subscale: blunted effect, emotional withdrawal, poor rapport, passive apathetic social withdrawal, difficulty in abstract thinking, lack of spontaneity and flow of conversation, and stereotyped thinking, higher scores indicate worsening.
Measured: Baseline and Week 13 or early discontinuation
Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation
Positive Syndrome Scale (range 7-49): Sum of scores for items 1-7 in positive subscale: delusions, conceptual disorganization, hallucinatory behavior, excitement, grandiosity, suspiciousness/persecution, and hostility, higher scores indicate worsening.
Measured: Baseline and Week 13 or early discontinuation
Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation
General Psychopathology (range 16-112): Sum of scores for somatic concern, anxiety, guilt feelings, tension, mannerisms/posturing, depression, motor retardation, uncooperativeness, unusual thought content, disoriented, poor attention, lack of judgment/insight, disturbance of volition, poor impulse control, preoccupation, and active social avoidance, higher scores indicate worsening.
Measured: Baseline and Week 13 or early discontinuation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2011 (estimated)
- Study startOct 2010
- Primary completionMay 2012
- Study completionMay 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.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 323 participants (actual)
Sponsor and investigators
- Lead sponsor
- Janssen Pharmaceutical K.K.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Janssen Pharmaceutical K.K. Clinical Trial, Study director, Janssen Pharmaceutical K.K.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01299389
- Sponsor's protocol ID
- CR017026
- Other IDs
- PALM-JPN-4
- Status last verified
- Jun 2013
- First submitted
- 27 Jan 2011
- Last updated
- 17 Jun 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Fixed-Dose, Multicenter Study of JNS010 (Paliperidone Palmitate) in Patients With Schizophrenia
- ClinicalTrials.gov ID
- NCT01299389
- Acronym / sponsor ID
- CR017026
- Conditions
- Schizophrenia
- Keywords
- Paliperidone palmitate, Schizophrenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 323 participants (actual)
- Lead sponsor
- Janssen Pharmaceutical K.K.Industry (pharma, biotech, devices)
- Study start
- Oct 2010
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 18 Feb 2011 (estimated)
- Results
- Posted 17 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 paliperidone palmitate as compared with placebo in the treatment of participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions [a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder] and hallucinations [imagining things], and withdrawal into the self).
Detailed description
This is a randomized (the study drug is assigned by chance), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-controlled (an inactive substance; a pretend treatment [with no drug in it] that is compared in a clinical trial with a drug to test if the drug has a real effect), parallel-group (comparing the response in two groups of participants receiving different treatments), fixed-dose, multi-center (when more than one hospital or medical school team work on a medical research study) study of paliperidone palmitate in participants with schizophrenia. The study will consist of 3 periods: an up to 2-week pre-observation (screening) period, a double-blind period from Day 1 (baseline) to Week 13 (end of double-blind period) assessment, and a post-observation period starting after the Week 13 assessment to Week 21. For participants who discontinue the study before the last assessment in Week 13, the post-observation period will start after the discontinuation from double-blind period assessment with follow-up visits at 4, 8, and 12 weeks after the last injection. After completion of the double-blind period (Week 13), discontinuation of double-blind period treatment or withdrawal from the study, participants may receive treatment consistent with the usual standard of care. The total duration of the study will be 21 weeks, including the double-blind and post-observation periods. Participants will be randomly assigned to 1 of 2 treatment groups in a 1:1 ratio (intramuscular injections of either paliperidone palmitate or matching placebo). Injections of paliperidone palmitate or placebo will be given at Day 1 and at Weeks 1, 5, and 9 by a study drug manager and/or injector. For those participants receiving paliperidone palmitate, the Day 1 injection will be 150 milligram equivalent (mg eq.) paliperidone palmitate, followed by 100 mg eq. injections of paliperidone palmitate at Week 1, and 75 mg eq. injections of paliperidone palmitate at Weeks 5 and 9. Participants randomly assigned to placebo will receive injections matching the paliperidone palmitate injections on the same days. Efficacy will be assessed using Positive and Negative Syndrome Scale (PANSS), Clinical Global Impression - Severity (CGI-S). Participant's safety will be monitored throughout the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paliperidone palmitate | Experimental | Drug: Paliperidone palmitate |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants meeting Diagnostic criteria for schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision
- Women had to be: postmenopausal (for at least 2 years), surgically sterile (had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent (as judged by the investigator; per local regulations), or if sexually active, be practicing a highly effective method of birth control (eg, prescription oral contraceptives, contraceptive injections, contraceptive patch, intrauterine device, double-barrier method [eg, condoms, diaphragm, or cervical cap, with spermicidal foam, cream, or gel], male partner sterilization) as local regulations permitted, before entry, and had to agree to continue to use the same method of contraception throughout the study
- A Positive and Negative Syndrome Scale (PANSS) total score at screening and at baseline (Day 1) of 60 to 120
- Documented history of exposure to either a risperidone formulation or a paliperidone formulation and known to be tolerated before baseline (Day 1) (Even if the participant's experience of taking risperidone or paliperidone cannot be confirmed at the time of informed consent, the participant will be able to meet this criterion if the participant takes oral risperidone 2 mg/day or more or paliperidone ER 6 mg/day or more for at least 4 days between the day of informed consent and the day before baseline, and it is possible to confirm that there is no lack of tolerability in the participant)
- Women of childbearing potential must have a negative beta human chorionic gonadotropin pregnancy test at the screening urine pregnancy test
Key exclusion criteria (5 listed)
- Primary active Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision Axis I diagnosis other than schizophrenia
- A Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition Text Revision diagnosis of active substance dependence within 3 months before screening (nicotine and caffeine are not exclusionary)
- Relevant history or current presence of any significant or unstable cardiovascular, respiratory, neurological (including seizures or significant cerebrovascular), renal, hepatic, hematologic, endocrine, immunologic, or other systemic disease
- History or current presence of neuroleptic malignant syndrome or tardive dyskinesia
- Known or suspected hypersensitivity or intolerance to risperidone, paliperidone, Intralipid, or any of their excipients (including egg yolks, soybean oil, phospholipids, and glycerol)
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 palmitatePaliperidone palmitate will be given intramuscularly as an initial loading dose of 150 milligram (mg) equivalents (eq.) on Day 1 and 100 mg eq. on Day 8, followed by 75 mg eq. on Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period. | Drug | Paliperidone palmitate |
| PlaceboMatching Placebo will be given intramuscularly (Injection of a drug into a muscle) on Day 1, Day 8, Day 36 and Day 64. Participants who complete double-blind period or discontinued early from double-blind period will have follow-up visits during post-observational period at Weeks 4, 8 and 12 after the last injection in the double-blind period. Participants will not receive any study drug during post-observational period. | Drug | Placebo |
Primary outcome
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation
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
Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation
Participants With Response to the Treatment as Per PANSS Total Score.
Time frame: up to Week 13 or early discontinuation
Change From Baseline in PANSS Marder Subscale Scores at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation (ED)
Change From Baseline in PANSS Negative Subscale Score at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation
Change From Baseline in PANSS Positive Subscale Score at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation
Change From Baseline in PANSS General Psychopathology Subscale Score at Week 13 or Early Discontinuation
Time frame: Baseline and Week 13 or early discontinuation
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2013.
- 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 Pharmaceutical K.K. Clinical Trial study director
Janssen Pharmaceutical K.K.
56 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone palmitate in people with Schizophrenia, run by Janssen Pharmaceutical K.K. at 56 sites in 3 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 17 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 56 sites in Japan, South Korea, Taiwan. 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. Some participants in this study may receive a placebo. 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 17 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 Week 13 or Early Discontinuation (time frame: Baseline and Week 13 or early discontinuation). 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 17 Jun 2013.