SchizophreniaPhase 3NCT01662310
An Efficacy Study of Paliperidone for the Prevention of Relapse in Participants With Schizophrenia
A Phase 3 study testing Paliperidone in people with Schizophrenia, run by Janssen Research & Development, LLC at 14 sites in China.
Trial summary
The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants. 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
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 201 participants
- Where
- 14 sitesChina
- Study dates
- Jun 2011to Apr 2013
- 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
- Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
- Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline
- Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
- Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Be willing and capable to complete the questionnaires and able to take oral medications independently
Who cannot join
- Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
- Participants with Crohn's disease and hepatic or renal diseases
- Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
- Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
- Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
- Had been treated with clozapine for treatment refractory or treatment resistant schizophrenia
Show all 9Show fewer
- Has significant risk of suicide or homicidal behavior, or significant risk of deliberate self harm or harm to others
- Has taken isocarboxazid, phenelzine, selegiline and tranylcypromine within 4 weeks before screening
- Has received electroconvulsive therapy within 60 days before screening
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
China14 sites
Study site
Baoding
Study site
Beijing
Study site
Changsha
Study site
Chengdu
Study site
Guangzhou
Study site
Harbin
Study site
Kunming
Study site
Nanjing
Study site
Shanghai
Study site
Taiyuan
Study site
Tianjin
Study site
Wuhan
Study site
Xi'an
Study site
Xinxiang
About this study
Official title: Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
The purpose of this study is to evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants.
Read the detailed description
This is a double-blind (neither physician nor participant knows the name of the assigned drug), randomized (participants are assigned to treatment by a chance), placebo-controlled, and parallel-group study of paliperidone ER tablets. The study will consist of 6 phases: 14 days of screening phase, 8 weeks of open-label run-in phase (participants will be flexibly dosed with paliperidone ER once daily in a dose range of 3 mg to 12 mg), 6 weeks of stabilization phase (participants will continue to receive the fixed dose of paliperidone ER), double-blind (DB) phase of various length (participants will be randomly assigned in a 1:1 ratio to receive either paliperidone ER or placebo and this phase will be completed after 86 relapse events are observed or if the study is positive at the interim analysis), 6 months of open-label extension (participants who experience a relapse event or who remain relapse free for the entire duration of the double-blind phase and participants who are enrolled at the time the study is terminated, will be eligible for this phase. All participants will be treated with paliperidone ER and safety and tolerability information will be collected during this phase) phase and 6 months of follow-up phase (participants who withdraw during the DB phase for any reason other than relapse will be followed for 6 months or until they experience a relapse). Participants' safety will be monitored throughout the study.
- Conditions
- Schizophrenia
- Being tested
- Paliperidone, Placebo
- Keywords
- Schizophrenia, Paliperidone, Paliperidone Extended-Release
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PaliperidoneDrug
Also called R076477
Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day.
PlaceboDrug
Participants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study.
| Study group | Role | What they receive |
|---|---|---|
| Paliperidone: Run-in or Stabilization phase | Experimental | Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose will be increased from milligram per day (3 mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day. Receives: Drug: Paliperidone |
| Paliperidone: Double blind (DB) phase | Experimental | Participants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg. Receives: Drug: Paliperidone |
| Placebo: DB phase | Active comparator | Participants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Double Blind (DB) Phase: Median Time to Relapse
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
Measured: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)
Secondary outcomes (14)
Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
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 14
Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
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. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Measured: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
The CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill.
Measured: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Measured: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported.
Measured: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Measured: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well").
Measured: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
Sleep quality was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how well they slept in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Measured: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well").
Measured: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
Daytime drowsiness was assessed by an 11-point visual analog scale that rates how well participants slept. Participants indicated on the scale (from 0 to 100 millimeter) how often they felt drowsy in the previous 7 days (from 0: "very badly" to 100: "very well"). Change at DB endpoint was calculated as value at interim analysis data cut-off (09 November 2012) minus value at DB Baseline (Day 1 of week 15).
Measured: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed final analysis at the end of double-blind treatment (09 November 2012).
Measured: DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
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. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Measured: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
CGI-S is a 7-point clinician-rated scale to assess severity of participant's current illness state, ranging from (1)Normal, not ill at all, (2)Borderline mentally ill, (3)Mildly ill, (4)Moderately ill, (5)Markedly ill, (6)Severely ill, (7)Among the most severely ill. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Measured: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
The PSP is 100-point validated clinician-rated scale that assesses degree of difficulty in 4 areas of functioning: socially useful activities, personal and social relationships, self-care, disturbing and aggressive behaviors rated on 6-point scale (1=absent to 6=very severe).Total transformed score from 1 to 100 is generated from raw score based on clinical interpretation of scores generated in 4 areas of functioning, with higher transformed score indicating better function. Total score is divided into 3 levels: 71-100 (mild difficulty); 31-70 (marked difficulty) and 1-30 (severe difficulty). Percentage of participants achieving improvement in PSP score by at least one category was reported. Change at OLE endpoint was calculated as value at OLE endpoint (24 weeks after DB phase (26 April 2013) minus value at OLE Baseline (09 November 2012).
Measured: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
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 2011
- Primary completionApr 2013
- Study completionApr 2013
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.
- 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
- 201 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
- NCT01662310
- Sponsor's protocol ID
- CR100427
- Other IDs
- R076477-SCH-3041
- Status last verified
- Sep 2014
- First submitted
- 29 Mar 2012
- Last updated
- 29 Sep 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Paliperidone Extended Release Tablets for the Prevention of Relapse in Subjects With Schizophrenia: A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study
- ClinicalTrials.gov ID
- NCT01662310
- Acronym / sponsor ID
- CR100427
- Conditions
- Schizophrenia
- Keywords
- Schizophrenia, Paliperidone, Paliperidone Extended-Release
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 10 Aug 2012 (estimated)
- Results
- Posted 6 Jun 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 evaluate the efficacy, tolerability and safety of paliperidone extended release (ER) tablets (between 3 to 12 milligram (mg), once a day) in the prevention of relapse in schizophrenia participants.
Detailed description
This is a double-blind (neither physician nor participant knows the name of the assigned drug), randomized (participants are assigned to treatment by a chance), placebo-controlled, and parallel-group study of paliperidone ER tablets. The study will consist of 6 phases: 14 days of screening phase, 8 weeks of open-label run-in phase (participants will be flexibly dosed with paliperidone ER once daily in a dose range of 3 mg to 12 mg), 6 weeks of stabilization phase (participants will continue to receive the fixed dose of paliperidone ER), double-blind (DB) phase of various length (participants will be randomly assigned in a 1:1 ratio to receive either paliperidone ER or placebo and this phase will be completed after 86 relapse events are observed or if the study is positive at the interim analysis), 6 months of open-label extension (participants who experience a relapse event or who remain relapse free for the entire duration of the double-blind phase and participants who are enrolled at the time the study is terminated, will be eligible for this phase. All participants will be treated with paliperidone ER and safety and tolerability information will be collected during this phase) phase and 6 months of follow-up phase (participants who withdraw during the DB phase for any reason other than relapse will be followed for 6 months or until they experience a relapse). 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
- 3
| Arm | Type | Receives |
|---|---|---|
| Paliperidone: Run-in or Stabilization phase | Experimental | Drug: PaliperidonePaliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) once daily for 8 weeks. Dose will be increased from milligram per day (3 mg/day) after 5 days based on Investigator's discretion, up to maximum of 12 mg/day. |
| Paliperidone: Double blind (DB) phase | Experimental | Drug: PaliperidoneParticipants who transitioned from run-in or stabilization phase received 3 to 12 mg fixed dose of paliperidone ER oral tablet once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg. |
| Placebo: DB phase | Active comparator | Drug: PlaceboParticipants who transitioned from run-in or stabilization phase received matching placebo to paliperidone ER once daily during DB phase of the study. Participants who will experience a relapse event during the DB phase or who will remain relapse free for the entire duration of the DB phase and participants, who will be enrolled at the time the study termination will enter in open label extension phase, wherein paliperidone ER oral tablet will be administered once daily as 3 to 12 mg. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Have a diagnosis of schizophrenia according to Diagnostic and Statistical Manual of Mental Disorders, 4th Edition (DSM-IV)
- Have experienced an acute episode, with a Positive and Negative Syndrome Scale (PANSS) total score between 70 and 120 inclusive, at Screening and Baseline
- Women must be postmenopausal (for at least 1 year), surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), practicing a highly effective method of birth control, if sexually active
- Men must be using a highly effective method of birth control and must not donate sperm during the study and for 3 months after receiving the last dose of study drug
- Be willing and capable to complete the questionnaires and able to take oral medications independently
Key exclusion criteria (9 listed)
- Has drug dependence diagnosis according to DSM-IV (excluding nicotine and caffeine dependence) within 6 months before screening
- Participants with Crohn's disease and hepatic or renal diseases
- Has had relevant history of any significant and/or unstable cardiovascular, respiratory, neurologic (including seizures or significant cerebrovascular dysfunction), renal, hepatic, endocrine, or immunologic diseases
- Has had history of neuroleptic malignant syndrome (the disorder caused by antipsychotic drugs with symptoms of fever, muscle rigidity and delirium)
- Has had known or suspected Stevens Johnson Syndrome (an immune disease with symptoms of fever, sore throat, ulcers and conjunctivitis) after exposure to phenytoin, carbamazepine, barbiturates, or lamotrigine
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 |
|---|---|---|
| PaliperidoneAlso: R076477Paliperidone extended-release (ER) oral tablet will be administered at a starting dose of 3 milligram (mg) up to 12 mg once daily for 8 weeks in Run-in or Stabilization phase, and 3-12 mg fixed dose oral tablet will be administered in DB phase. Participants who will enter open-label extension phase will receive paliperidone as 3-12 mg per day. | Drug | Paliperidone: Double blind (DB) phase, Paliperidone: Run-in or Stabilization phase |
| PlaceboParticipants who transitioned from run-in or stabilization phase will receive matching placebo to paliperidone ER once daily during DB phase of the study. | Drug | Placebo: DB phase |
Primary outcome
Double Blind (DB) Phase: Median Time to Relapse
Time frame: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)
A relapse is defined as any one of the following: 1. involuntary or voluntary psychiatric hospitalization 2. deliberate self-injury or violent behavior; 3. Suicidal or homicidal ideation and clinically significant aggressive behavior; 4. 25 percent (%) increase in Positive and Negative Syndrome Scale (PANSS) total score for 2 consecutive assessments for participants whose score was greater than 40 at randomization, or a 10-point increase for participants who scored less than or equal to (≤) 40 at randomization; 5. increase for 2 consecutive assessments in PANSS items (delusions, conceptual disorganization, hallucinatory behavior, suspiciousness, hostility or uncooperativeness) to greater than or equal to (≥) 5 for participants who scored ≤3 at randomization, or to ≥6 for participants with initial score of 4. Independent Data Monitoring Committee performed ongoing safety monitoring during double-blind treatment and conducted the interim analysis after 61 relapse events had taken place.
14 secondary outcomes
Run-In and Stabilization Phase: Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 14
Time frame: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at DB Endpoint
Time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Number of Participants Assessed With Categorical Scores Based on Clinical Global Impression-Severity Scale (CGI-S)
Time frame: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at DB Endpoint
Time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Personal and Social Performance (PSP) Scale Total Score at Week 14
Time frame: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Personal and Social Performance (PSP) Scale Total Score at DB Endpoint
Time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at Week 14
Time frame: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Sleep Quality Based on Visual Analog Scale (VAS) at DB Endpoint
Time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Run-In and Stabilization Phase: Change From Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at Week 14
Time frame: Baseline and Week 14
Double Blind (DB) Phase: Change From DB Baseline in Daytime Drowsiness Based on Visual Analog Scale (VAS) at DB Endpoint
Time frame: DB Baseline (Day 1 of Week 15) up to DB endpoint (study completion [09 November 2012] [Approximately 1 year])
Double Blind (DB) Phase: Median Time to Relapse (Final Analysis)
Time frame: DB Baseline (Day 1 of Week 15) up to study completion (09 November 2012) (Approximately 1 year)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at OLE Endpoint
Time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Clinical Global Impression-Severity Scale (CGI-S) Total Score at OLE Endpoint
Time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Open-label Extension (OLE) Phase: Change From OLE Baseline in Personal and Social Performance (PSP) Scale Total Score at OLE Endpoint
Time frame: OLE Baseline (09 November 2012) up to OLE endpoint (that is, up to 24 Weeks [26 April 2013] from DB endpoint)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 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 Research & Development, LLC Clinical Trial study director
Janssen Research & Development, LLC
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone in people with Schizophrenia, run by Janssen Research & Development, LLC at 14 sites in China.
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 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in China. 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 6 Jun 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?
Double Blind (DB) Phase: Median Time to Relapse (time frame: DB Baseline (Day 1 of Week 15) up to interim analysis data cut-off (24 August 2012) (Approximately 1 year)). 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 29 Sep 2014.