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An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Janssen Research & Development, LLC
ClinicalTrials.gov Identifier:
NCT01009047
First received: November 5, 2009
Last updated: June 20, 2013
Last verified: June 2013

November 5, 2009
June 20, 2013
December 2009
June 2012   (final data collection date for primary outcome measure)
Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56 [ Time Frame: Baseline and Day 56 ] [ Designated as safety issue: No ]
The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.
The primary efficacy endpoint will be the change in the PANSS total score from baseline to the Week 8 end point. [ Time Frame: Screening (from 21 days before the study begins [Day -21] to 1 day before the study begins [Day -1]), baseline (Day 1), Day 7, Day 14, Day 28, Day 56 (Week 8), Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01009047 on ClinicalTrials.gov Archive Site
  • Change From Baseline in PANSS Total Score at Day 182 [ Time Frame: Baseline and Day 182 ] [ Designated as safety issue: No ]
    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 From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182 [ Time Frame: Baseline, Day 56 and Day 182 ] [ Designated as safety issue: No ]
    The PANSS negative subscale based on marder factor assesses 7 negative-symptoms of schizophrenia. Negative symptoms represent a diminution or loss of normal functions. The symptoms are rated on a 7-point scale, with a range of 7 (absent) to 49 (extreme psychopathology).
  • Change From Baseline in Other Marder Factors Scores at Day 56 and 182 [ Time Frame: Baseline, Day 56 and 182 ] [ Designated as safety issue: No ]
    The subscales based on marder factors are: positive symptoms, disorganised thoughts factor, uncontrolled hostility/excitement factor, and anxiety/depression factor. The symptoms are rated on a 7-point scale, with a range of 8 to 56 for positive symptoms, 7 to 49 for disorganized thoughts and 4 to 28 for Uncontrolled hostility/excitement and anxiety/depression. Higher score indicate worsening.
  • Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182 [ Time Frame: Baseline, Day 56 and 182 ] [ Designated as safety issue: No ]
    The PANSS provides a total score (sum of the scores of all 30 items) and scores for 3 subscales, the positive subscale (7 items), the negative subscale (7 items), and the general psychopathology subscale (16 items), each rated on a scale of 1 (absent) to 7 (extreme).
  • Number of Participants With Clinical Stability [ Time Frame: Day 56 and 182 ] [ Designated as safety issue: No ]
    Clinical stability is defined as a decrease of 20 percent or more from Baseline in PANSS total score and CGI-S score less than or equal to 4 at Days 56 and 182, no hospitalizations due to psychiatric illness and no emergence of clinically significant suicidal or homicidal ideation during the maintenance phase.
  • Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182 [ Time Frame: Baseline, Day 56 and 182 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182 [ Time Frame: Baseline, Day 56 and Day 182 ] [ Designated as safety issue: No ]
    The PSP scale assesses degree of a participants' dysfunction within 4 domains of behavior: socially useful activities, personal and social relationships, self-care, and disturbing and aggressive behavior. The results of the assessment are converted to a numerical score to rate degree of difficulty (1=absent to 6=very severe) in each of the 4 domains. Based on 4 domains there will be 1 total score (total score ranges from 1 to 100, divided into 10 equal intervals). Participants with score of 71 to 100 have mild degree of difficulty; from 31 to 70, varying degrees of disability; less than or equal to 30, functioning so poorly as to require intensive supervision.
  • Number of Participants With PANSS Response [ Time Frame: Day 56 and 182 ] [ Designated as safety issue: No ]
    The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Participants with PANSS response were defined as those who achieved greater than or equal to 20 percent or higher reduction from Baseline in the PANSS total score at Day 56 and 182.
  • A secondary endpoint will be the change from baseline in the PANSS total score at Week 26. [ Time Frame: Screening (Day -21 to Day -1), baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  • A secondary endpoint will be the change from baseline in CGI-S score at Week 8 and Week 26. [ Time Frame: Baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  • A secondary endpoint will be the change from baseline in Personal and Social Performance score at Week 8 and Week 26. [ Time Frame: Baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  • A secondary endpoint will be the proportion of patients maintaining clinical stability at Week 26 (as measured from Week 8) based on PANSS total score and Clinical Global Impression Severity (CGI-S), suicidality or homicidal ideas, or hospitalization. [ Time Frame: Day 56 (Week 8), Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
  • A secondary endpoint will be the change from baseline in the PANSS negative symptom factor score (based on Marder factor) at Week 8 and Week 26. [ Time Frame: Screening (Day -21 to Day -1), baseline (Day 1), Day 7, Day 14, Day 28, Day 56, Day 98, Day 140, Day 182 (end of study), or at early withdrawal ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
A Randomized, Multicenter, Double-Blind, Active-Controlled, Flexible-Dose, Parallel-Group Study of the Efficacy and Safety of Extended Release Paliperidone for the Treatment of Symptoms of Schizophrenia in Adolescent Subjects, 12 to 17 Years of Age

The purpose of this study is to evaluate the efficacy and safety of extended-release (ER) paliperidone compared to aripiprazole (atypical antipsychotic) in symptomatic (having symptoms) adolescent participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations [imagining things], and withdrawal into the self) .

This is a multi-center (conducted in more than 1 center), double-blind (neither physician nor participant knows the name of the assigned drug), randomized (study drug is assigned by chance), active-controlled (paliperidone ER is compared to aripiprazole), parallel-group (a medical research study comparing the response in 2 or more groups of participants receiving different treatments), flexible-dose (the physician has the freedom to give different doses to the participant depending on how they respond to treatment) study designed to determine the efficacy and safety of paliperidone ER in symptomatic adolescents (12 to 17 years of age) with schizophrenia. The total duration of the study will be approximately 29 weeks. The study consists of 3 phases: a Screening phase up to 3 weeks (with a possible overlapping washout period), a Double-blind acute phase of 8 weeks, and a Double-blind maintenance phase of 18 weeks. Participants will be randomly assigned to 1 of the 2 treatment groups (paliperidone ER or aripiprazole flexible oral doses). Dosage will be adjusted at the scheduled visits. Efficacy of the participants will primarily be evaluated through Positive and Negative Syndromes Scale (PANSS). Participants' safety will be monitored throughout the study.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: Paliperidone extended release (ER)
    Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
  • Drug: Aripiprazole
    Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
  • Experimental: Paliperidone extended-release (ER)
    Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.
    Intervention: Drug: Paliperidone extended release (ER)
  • Active Comparator: Aripiprazole
    Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.
    Intervention: Drug: Aripiprazole
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
228
June 2012
June 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Participants must currently meet the Diagnostic and Statistical Manual of Mental Disorders Fourth Edition (DSM-IV) criteria for schizophrenia and have experienced symptoms of the illness for at least 1 year, and they should have had at least treatment with 1 antipsychotic before participation in this study
  • Participants having a Positive and Negative Syndromes Scale (PANSS) score between 60 and 120 inclusive at Screening
  • Female participants must be incapable of pregnancy, or if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception for at least 1 month before study entry and agree to continue use contraception methods for the duration of the study, or if sexually abstinent (not having sexual intercourse) and capable of pregnancy, must agree to continue abstinence or to use an acceptable method of birth control
  • Participants must not be a danger to themselves or others, and must have family support available to be maintained as out-patients
  • Participants with a weight of equal to or greater than 29 kilogram

Exclusion Criteria:

  • Participants with mild (not serious), moderate (medium level of seriousness), or severe (very serious, life threatening) mental retardation
  • Participants with a known or suspected history of substance dependence (including alcohol, but excluding nicotine or caffeine) as per the DSM-IV criteria in the 3 months before Screening
  • Participants with a history of certain neurological (pertaining to the nervous system) disorders or insulin-dependent diabetes mellitus (disorder in which there is decreased insulin in the body or the body's insulin is not effective, resulting in high blood sugar, increased thirst and urine, and many other side effects)
  • Participants who have received a depot injectable antipsychotic within 2 treatment cycles before the Screening visit
  • Participants who have received clozapine in 2 months before the Baseline visit (Day 1 of Week 1)
Both
12 Years to 17 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   India,   Romania,   Russian Federation,   Slovakia,   Spain,   Ukraine
 
NCT01009047
CR016675, R076477PSZ3003
No
Janssen Research & Development, LLC
Janssen Research & Development, LLC
Not Provided
Study Director: Janssen Research & Development, LLC Clinical Trial Janssen Research & Development, LLC
Janssen Research & Development, LLC
June 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP