Clinical trial NCT01009047: An Efficacy and Safety Study of Extended-Release (ER) Paliperidone in Adolescent Participants With Schizophrenia
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Schizophrenia
Keywords: Schizophrenia
Paliperidone
Aripiprazole
Lead sponsor: Janssen Research & Development, LLC
Sponsor class: INDUSTRY
First posted: 2009-11-06
Enrollment: 228
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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) .

Detailed description: 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.

Eligibility criteria: 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)

Primary outcomes:
measure: Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score at Day 56
timeFrame: Baseline and Day 56
Secondary outcomes:
measure: Change From Baseline in PANSS Total Score at Day 182
timeFrame: Baseline and Day 182
measure: Change From Baseline in Marder Factor Negative Symptoms Score at Day 56 and 182
timeFrame: Baseline, Day 56 and Day 182
measure: Change From Baseline in Other Marder Factors Scores at Day 56 and 182
timeFrame: Baseline, Day 56 and 182
measure: Change From Baseline in Other PANSS Factors and Subscales at Day 56 and 182
timeFrame: Baseline, Day 56 and 182
measure: Number of Participants With Clinical Stability
timeFrame: Day 56 and 182
measure: Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score at Days 56 and 182
timeFrame: Baseline, Day 56 and 182
measure: Change From Baseline in Personal and Social Performance (PSP) Scores at Day 56 and 182
timeFrame: Baseline, Day 56 and Day 182
measure: Number of Participants With PANSS Response
timeFrame: Day 56 and 182
Other outcomes:
Locations:
city: Dothan
country: United States
state: Alabama
city: Santa Ana
country: United States
state: California
city: Atlanta
country: United States
state: Georgia
city: Smyrna
country: United States
state: Georgia
city: Lake Charles
country: United States
state: Louisiana
city: Shreveport
country: United States
state: Louisiana
city: Jaipur
country: India
city: Kanpur Uttarpradeh
country: India
city: Lucknow Gpo
country: India
city: Mangalore
country: India
city: Varanasi
country: India
city: Bucharest
country: Romania
city: Chelyabinsk
country: Russian Federation
city: Ekaterinburg Na
country: Russian Federation
city: Krasnodar N/A
country: Russian Federation
city: Moscow N/A
country: Russian Federation
city: Moscow Russia
country: Russian Federation
city: Nizhniy Novgorod
country: Russian Federation
city: Novosibirsk
country: Russian Federation
city: Saint Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Saratov
country: Russian Federation
city: Smolensk Region N/A
country: Russian Federation
city: St Petersburg
country: Russian Federation
city: St-Petersburg
country: Russian Federation
city: Tomsk Na
country: Russian Federation
city: Yaroslavl N/A
country: Russian Federation
city: Bratislava
country: Slovakia
city: Badajoz
country: Spain
city: Esplugues De Llobregat
country: Spain
city: Madrid
country: Spain
city: Paterna
country: Spain
city: Sabadell
country: Spain
city: Sevilla
country: Spain
city: Valladolid
country: Spain
city: Donetsk
country: Ukraine
city: Glevakha
country: Ukraine
city: Ivano-Frankivsk
country: Ukraine
city: Ivano-Frankovsk
country: Ukraine
city: Kharkiv
country: Ukraine
city: Kherson
country: Ukraine
city: Kiev
country: Ukraine
city: Poltava
country: Ukraine
city: Simferopol
country: Ukraine
Study officials:
affiliation: Janssen Research & Development, LLC
name: Janssen Research & Development, LLC Clinical Trial
role: STUDY_DIRECTOR
References:
citation: 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.