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

NCT01009047 | Completed Phase 3 Results

• 2 other identifiers: CR016675R076477PSZ3003
• Study Type: interventional
• Target: 228
• Locations: 7 countries
• Sites: 41

Brief Summary

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

Conditions

Schizophrenia

Keywords

Schizophrenia; Paliperidone; Aripiprazole

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56

  The PANSS is a 30-item scale with each item rated on a scale of 1 (absent) to 7 (extreme psychopathology), designed to assess various symptoms of schizophrenia including delusions, grandiosity, blunted affect, poor attention, and poor impulse control. The PANSS total score consists of the sum of all 30 PANSS items and ranges from 30 to 210. Higher scores indicate worsening.

  Baseline and Day 56

Secondary Outcomes (8)

• Change From Baseline in PANSS Total Score at Day 182

  Baseline and Day 182

• Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182

  Baseline, Day 56 and Day 182

• Change From Baseline in Other Marder Factors Scores at Day 56 and 182

  Baseline, Day 56 and 182

• Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182

  Baseline, Day 56 and 182

• Number of Participants With Clinical Stability

  Day 56 and 182

Study Arms (2)

Paliperidone extended-release (ER)

EXPERIMENTAL

Paliperidone ER will be administered as oral capsule at a dose of 6 milligram (mg) for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

Drug: Paliperidone extended release (ER)

Aripiprazole

ACTIVE COMPARATOR

Aripiprazole will be administered as oral capsule at a dose of 2 mg on Days 1 and 2, 5 mg on Days 3 and 4, 10 mg Days 5, 6 and 7; and then will be administered as a dose of either 5 or 10 or 15 mg up to Week 26, once daily in the morning.

Drug: Aripiprazole

Interventions

Paliperidone extended release (ER) DRUG

Paliperidone ER will be administered as oral capsule at a dose of 6 mg for 1 week and then will be administered at a dose of either 3, 6 or 9 mg up to Week 26, once daily in the morning.

Paliperidone extended-release (ER)

Aripiprazole DRUG

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.

Aripiprazole

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Janssen Research & Development, LLC: lead

Study Sites (41)

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Dothan, Alabama, United States

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Santa Ana, California, United States

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Atlanta, Georgia, United States

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Smyrna, Georgia, United States

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Lake Charles, Louisiana, United States

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Shreveport, Louisiana, United States

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Jaipur, India

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Kanpur Uttarpradeh, India

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Lucknow Gpo, India

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Mangalore, India

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Varanasi, India

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Bucharest, Romania

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Chelyabinsk, Russia

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Ekaterinburg Na, Russia

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Krasnodar, Russia

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Moscow, Russia

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Moscow Russia, Russia

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Nizhny Novgorod, Russia

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Novosibirsk, Russia

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Saint Petersburg, Russia

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Samara, Russia

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Saratov, Russia

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Smolensk Region N/A, Russia

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Tomsk Na, Russia

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Yaroslavl, Russia

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Bratislava, Slovakia

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Badajoz, Spain

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Esplugues de Llobregat, Spain

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Madrid, Spain

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Paterna, Spain

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Sabadell, Spain

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Seville, Spain

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Valladolid, Spain

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Donetsk, Ukraine

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Hlevakha, Ukraine

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Ivano-Frankivsk, Ukraine

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Kharkiv, Ukraine

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Kherson, Ukraine

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Kiev, Ukraine

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Poltava, Ukraine

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Simferopol, Ukraine

Location

Related Publications (1)

• Savitz AJ, Lane R, Nuamah I, Gopal S, Hough D. Efficacy and safety of paliperidone extended release in adolescents with schizophrenia: a randomized, double-blind study. J Am Acad Child Adolesc Psychiatry. 2015 Feb;54(2):126-137.e1. doi: 10.1016/j.jaac.2014.11.009. Epub 2014 Nov 25.

  PMID: 25617253 DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

Aripiprazole

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Senior Director, Clinical Leader
• Organization: Janssen Research & Development, LLC

+1-609-730-2436

Study Officials

• Janssen Research & Development, LLC Clinical Trial

  Janssen Research & Development, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2009
• First Posted: November 6, 2009
• Study Start: December 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 21, 2013
• Results First Posted: June 21, 2013

Record last verified: 2013-06

Locations

RU (13); SL (1); RO (1); ES (7); UA (8); US (6); IN (5)