SchizophreniaPhase 3NCT00488319
Open-label Study of Flexible-dose Paliperidone ER (Extended Release) to Treat Adolescent Schizophrenia.
A Phase 3 study testing Paliperidone ER in people with Schizophrenia and Schizophrenic Disorders, run by Janssen Research & Development, LLC at 53 sites in 11 countries.
Trial summary
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia. Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Schizophrenia, Schizophrenic Disorders, Psychotic Disorders
- 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
- 400 participants
- Where
- 53 sitesin 11 countries
- Study dates
- Jun 2007to Jul 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
- Meets the DSM-IV criteria for schizophrenia, otherwise physically healthy
- Weight >=63.9 pounds (29 kg)
- Must not be a danger to self or others and must have family support available to be maintained as outpatients
- Responsible adult must be available to accompany the patient to the investigational site at each visit.
Who cannot join
- Meets the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder
- mild, moderate, or severe mental retardation
- History of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months before screening
- pregnancy (for females)
- History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval.
Trial locations and contacts
53 sites in 11 countries.
53 sites in 11 countries
United States14 sites
Study site
Cerritos, California
Study site
Chicago, Illinois
Study site
Cincinnati, Ohio
Study site
Cleveland, Ohio
Study site
Coeur d'Alene, Idaho
Study site
Jacksonville, Florida
Study site
Lake Charles, Louisiana
Study site
Las Vegas, Nevada
Study site
Middletown, Connecticut
Study site
Oklahoma City, Oklahoma
Study site
San Diego, California
Study site
Santa Ana, California
Study site
Shreveport, Louisiana
Study site
Washington D.C., District of Columbia
Russia11 sites
Study site
Ekaterinburg Na
Study site
Kazan'
Study site
Moscow
Study site
Moscow Russia
Study site
Nizhny Novgorod
Study site
Saint Petersburg
Study site
Saratov
Study site
Smolensk Region N/A
Study site
Stavropol Na
Study site
Tomsk Na
Study site
Yaroslavl
Poland6 sites
Study site
Gdansk
Study site
Lódź
Study site
Poznan
Study site
Sosnowiec
Study site
Torun
Study site
Warsaw
Ukraine6 sites
Study site
Dnipro
Study site
Hlevakha
Study site
Kharkiv
Study site
Kiev
Study site
Odesa
Study site
Simferopol
India4 sites
Study site
Chennai
Study site
Hyderabad
Study site
Mangalore
Study site
Varanasi
South Korea4 sites
Study site
Cheonan
Study site
Gyeonggi-do
Study site
Kyunggi-Do
Study site
Seoul
About this study
Official title: A 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
The purpose of this open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
Read the detailed description
This is a 6-month, open-label study (the patient, investigator, and sponsor know the study drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose (1.5 to 12mg per day), extended-release (ER) paliperidone in adolescents with a diagnosis of schizophrenia. Patients who have completed study R076477PSZ3001 or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study. Patients may also enter this study directly without participating in R076477PSZ3001. This study consists of a 21-day screening and washout phase (to discontinue and "wash out" any medication not allowed in the study), an open-label treatment phase of up to 26 weeks during which all patients will take oral paliperidone ER every day, and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone ER. The study, including the screening and posttreatment phase, will last approximately 30 weeks. Screening and washout may be conducted while a patient is either an inpatient or an outpatient. Safety will be assessed by laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid assessments, prolactin [blinded], urinalysis, and urine drug screens); body weight, height, and waist circumference measurements; ECGs; and physical examinations (including Tanner staging). The Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Rating Scale (SAS) will be used to assess extrapyramidal symptoms (EPS) and dyskinesias. Adverse events will be monitored including psychiatric adverse events of interest (i.e., suicide and related phenomena, homicidal ideation, depressed mood, and worsening of psychosis) that may be associated with paliperidone ER in this population. The primary aim of this study is to evaluate the long-term (6-month) safety and tolerability of paliperidone ER in adolescents with schizophrenia. As exploratory secondary aims, the study will assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores, the global improvement in severity of illness as measured by the Clinical Global Impression-Severity (CGI-S) scale, the benefits in psychological, social, and school functioning as measured by the Children's Global Assessment Scale (CGAS), the changes in multiple domains of cognitive functioning measured by the modified Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery, and the effect on sleep as measured by the sleep Visual Analog Scale (VAS). Patients begin the study at 6.0 mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day or 1.5 mg/day. Patients will be dosed for up to 6 months.
- Being tested
- Paliperidone ER
- Keywords
- Schizophrenia, Adolescent, Paliperidone, Antipsychotic agents, Antipsychotic drugs, Psychosis.
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paliperidone ERDrug
1.5 to 12 mg tablet once daily for 6 months
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | Paliperidone ER1.5 to 12 mg tablet once daily for 6 months Receives: Drug: Paliperidone ER |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability
A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
Measured: Up to 2 years
Secondary outcomes (19)
Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward
The PANSS is a medical scale that assesses various symptoms of schizophrenia. The symptoms are rated on a 7-point scale from 1 (absent) to 7 (extreme psychopathology). The total score is the sum of all 30 PANSS items, with a range of 30 (absent) to 210 (extreme ill).
Measured: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward
Neuropsychiatric symptoms of schizophrenia were assessed using the 30-item PANSS scale. PANSS scale provides a total score (sum of scores of all 30 items) and scores for 3 subscales, ie, positive (7 items), negative (7 items), and general psychopathology (16 items) subscales. Each item is scored on a scale of 1 (absent) to 7 (extreme). Positive Factor Score (range: 8 to 56): sum of select scores from positive, negative, and general psychopathology subscales. Negative Factor Score (range: 7 to 49): sum of select scores from negative and general psychopathology subscales. Disorganized Thoughts Factor Score (range: 7 to 49): sum of select scores from positive, negative, and general psychopathology subscales. Uncontrolled Hostility/Excitement Factor Score (range: 4 to 28): sum of select scores from positive and general psychopathology subscales. Anxiety/Depression Factor Score (range: 4 to 28): sum of select scores from general psychopathology subscale. Higher scores indicate worsening.
Measured: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward
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, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward
The CGAS is a 100 point rating scale which measures the psychological, social, and school functioning for children 6 to 17 years of age. The score ranges from 1 to 100, divided into 10 equal intervals to rate the impairment level of general functioning (poor to superior functioning). Higher scores denote better functioning.
Measured: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward
A comprehensive neuropsychological examination that measures different domains of cognitive functioning is provided. They are either assessed as T-scores [mean=50, SD=10 range 1-100]; z-scores [mean=0, SD=1, and can be positive or negative] or scaled scores [mean=10, SD=3, and can be positive or negative]. The theory-of-mind total score is a raw score that ranges from 1 to 100. Higher scores for all scales denote better performance.
Measured: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward
Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.
Measured: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward
Sleep VAS is a self administered scale that rates the quality of sleep and daytime drowsiness. Participants make a mark on a line to represent how well they have slept in the previous 7 days ("very badly" to "very well") and how often they have felt drowsy within the previous 7 days ("not at all" to "all the time"). The score for each item ranges from 0 to 100 mm. For quality of sleep, a score of 0 indicates "Very badly" and a score of 100 indicates "Very well." For daytime drowsiness, a score of 0 indicates "Not at all" and a score of 100 indicates "All the time." Improvement of the condition is indicated by the positive change for the quality of sleep and the negative change for the daytime drowsiness.
Measured: Baseline, Week 104 or the last post-baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2007 (estimated)
- Study startJun 2007
- Primary completionJul 2012
- Study completionJul 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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
- NCT00488319
- Sponsor's protocol ID
- CR012616
- Other IDs
- R076477PSZ3002
- Status last verified
- Nov 2013
- First submitted
- 18 Jun 2007
- Last updated
- 10 Feb 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Gopal S, Lane R, Nuamah I, Copenhaver M, Singh J, Hough D, Bach M, Savitz A. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. CNS Drugs. 2017 Sep;31(9):797-808. doi: 10.1007/s40263-017-0437-9.
PubMed 28660406
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 6-Month, Open-Label, Single-Arm Safety Study of Flexibly Dosed Paliperidone Extended Release (1.5 - 12 mg/Day) in the Treatment of Adolescents (12 to 17 Years of Age) With Schizophrenia
- ClinicalTrials.gov ID
- NCT00488319
- Acronym / sponsor ID
- CR012616
- Keywords
- Schizophrenia, Adolescent, Paliperidone, Antipsychotic agents, Antipsychotic drugs, Psychosis.
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Janssen Research & Development, LLCIndustry (pharma, biotech, devices)
- Study start
- Jun 2007
- Primary completion
- Jul 2012 (actual)
- Study completion
- Jul 2012 (actual)
- First posted
- 20 Jun 2007 (estimated)
- Results
- Posted 6 Jan 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 open-label study is to evaluate the long-term (6-month) safety and tolerability of extended-release paliperidone, an atypical antipsychotic, given in flexible dosages to adolescents with schizophrenia.
Detailed description
This is a 6-month, open-label study (the patient, investigator, and sponsor know the study drug and dosage being taken by the patient) of the safety and tolerability of flexible-dose (1.5 to 12mg per day), extended-release (ER) paliperidone in adolescents with a diagnosis of schizophrenia. Patients who have completed study R076477PSZ3001 or who discontinued from that study because of lack of efficacy but completed a minimum of 21 days of the study may enter this study. Patients may also enter this study directly without participating in R076477PSZ3001. This study consists of a 21-day screening and washout phase (to discontinue and "wash out" any medication not allowed in the study), an open-label treatment phase of up to 26 weeks during which all patients will take oral paliperidone ER every day, and a post-treatment phase consisting of a follow-up visit completed 1 week after a patient has received the final dose of paliperidone ER. The study, including the screening and posttreatment phase, will last approximately 30 weeks. Screening and washout may be conducted while a patient is either an inpatient or an outpatient. Safety will be assessed by laboratory measurements (chemistry, liver function tests, hematology, hormone, lipid assessments, prolactin [blinded], urinalysis, and urine drug screens); body weight, height, and waist circumference measurements; ECGs; and physical examinations (including Tanner staging). The Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Rating Scale (SAS) will be used to assess extrapyramidal symptoms (EPS) and dyskinesias. Adverse events will be monitored including psychiatric adverse events of interest (i.e., suicide and related phenomena, homicidal ideation, depressed mood, and worsening of psychosis) that may be associated with paliperidone ER in this population. The primary aim of this study is to evaluate the long-term (6-month) safety and tolerability of paliperidone ER in adolescents with schizophrenia. As exploratory secondary aims, the study will assess the effect of paliperidone ER on the long-term symptoms of schizophrenia as measured by the changes in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) scores, the global improvement in severity of illness as measured by the Clinical Global Impression-Severity (CGI-S) scale, the benefits in psychological, social, and school functioning as measured by the Children's Global Assessment Scale (CGAS), the changes in multiple domains of cognitive functioning measured by the modified Measurements and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) assessment battery, and the effect on sleep as measured by the sleep Visual Analog Scale (VAS). Patients begin the study at 6.0 mg/day of oral paliperidone ER. If a higher dosage is needed, the dosage will be increased (in increments of 3 mg/day not more frequently than once every 5 days) to 12 mg/day. If the 6.0 mg/day dosage is not well tolerated, the dosage may be decreased (not more frequently than once every 5 days) to 3.0 mg/day or 1.5 mg/day. Patients will be dosed for up to 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: Paliperidone ERPaliperidone ER1.5 to 12 mg tablet once daily for 6 months |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Meets the DSM-IV criteria for schizophrenia, otherwise physically healthy
- Weight >=63.9 pounds (29 kg)
- Must not be a danger to self or others and must have family support available to be maintained as outpatients
- Responsible adult must be available to accompany the patient to the investigational site at each visit.
Key exclusion criteria (5 listed)
- Meets the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder
- mild, moderate, or severe mental retardation
- History of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months before screening
- pregnancy (for females)
- History or presence of circumstances that may increase the risk of the occurrence of torsade de pointes or sudden death in association with the use of drugs that prolong the QTc interval.
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 ER1.5 to 12 mg tablet once daily for 6 months | Drug | 001 |
Primary outcome
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability
Time frame: Up to 2 years
A serious adverse event as defined by the International Conference on Harmonisation (ICH) is any untoward medical occurrence that at any dose results in death, is life-threatening (the subject was at risk of death at the time of the even; it does not refer to an event that hypothetically might have caused death if it were more severe), requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, or is a congenital anomaly/birth defect.
19 secondary outcomes
Change From Open-label Baseline to Open-label Endpoint in Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Scores - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Positive and Negative Syndrome Scale for Schizophrenia (PANSS) Based on Marder Factors - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Clinical Global Impression Severity (CGI-S) Scale - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Children's Global Assessment Scale (CGAS) - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Motor Speed Domain Test Variable, Finger Tapping Dominant- and Non-Dominant Hand, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Coding, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Attention/Working Memory Domain Test Variable Digit Span, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label - Cognitive Domain: Verbal Learning and Memory Domain Test Variable Wide Range Assessment of Memory and Learning Story - Total, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Verbal Learning and Memory Domain Test Variable California Verbal Learning Test-Total Trials, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Visual Learning and Memory Domain Test Variable, Rey Complex Figure Test - Total, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Social Cognition Domain Test Variable - Theory of Mind-Total - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open Label Baseline to Open Label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Trials Part A Time: Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Child Color Trials Test 1 Time: Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Phonetic Verbal Fluency: Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Speed of Processing Domain Test Variable Semantic Verbal Fluency, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable, Trials Part B Time, Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint - Cognitive Domain: Executive Functioning (Reasoning and Problem Solving) Domain Test Variable - Wisconsin Card Sort Test-Total Errors: Scaled - Last Observation Carried Forward
Time frame: Baseline, Week 24
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Quality of Sleep - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Change From Open-label Baseline to Open-label Endpoint in the Sleep Visual Analog Scale (VAS): Daytime Drowsiness - Last Observation Carried Forward
Time frame: Baseline, Week 104 or the last post-baseline assessment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 28660406Gopal S, Lane R, Nuamah I, Copenhaver M, Singh J, Hough D, Bach M, Savitz A. Evaluation of Potentially Prolactin-Related Adverse Events and Sexual Maturation in Adolescents with Schizophrenia Treated with Paliperidone Extended-Release (ER) for 2 Years: A Post Hoc Analysis of an Open-Label Multicenter Study. CNS Drugs. 2017 Sep;31(9):797-808. doi: 10.1007/s40263-017-0437-9.
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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
53 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Paliperidone ER in people with Schizophrenia and Schizophrenic Disorders, run by Janssen Research & Development, LLC at 53 sites in 11 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 4 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 10 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 53 sites in United States, Russia, Poland, Ukraine, India and 6 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 6 Jan 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?
The Number of Participants Who Experienced Adverse Events as a Measure of Safety and Tolerability (time frame: Up to 2 years). 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 NCT00488319, 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 10 Feb 2017.