A 2-Year, 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

• Conditions: Adolescent Schizophrenia; MedDRA version: 9.1Level: LLTClassification code 10008525Term: Childhood schizophrenia

• Registration Number: EUCTR2007-000577-38-EE
• Lead Sponsor: Janssen-Cilag International NV, Turnhoutseweg 30, 2340 Beerse, Belgium

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2007-06-04
• Last Update Posted: 19 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 400

Inclusion Criteria

• Male or female between 12 and 17 years of age, inclusive. (Subject may become 18 years of age during the study but should be 17 years of age at the time of signing the informed consent)
• Subject must give assent to participate before screening procedures begin
• Parent(s) or the legal guardian(s) of the subject must sign an informed consent document indicating that they understand the purpose of and the procedures required for the study and give permission for their child’s participation in the study before screening procedures begin
• Subjects must not be a danger to themselves or others, and must have family support available to be maintained as outpatients. The K-SADS-PL diagnostic interview: item a), recurrent thoughts of death; item b), suicidal thoughts; item c), suicide attempts and their seriousness; item d), suicide attempts and their lethality; and item e) self-harming behavior must have a score of =2 for each item.
• Weight =29 Kg
• Female subjects must either:
– be incapable of pregnancy because of hysterectomy or tubal ligation.
– if heterosexually active and capable of pregnancy, have been using an acceptable method of contraception (hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier methods) for at least 1 month before study entry and agree to continue the use of one of these contraception methods for the duration of the study.
– if sexually abstinent and capable of pregnancy, agree to continue abstinence or to use an acceptable method of birth control (either hormonal contraceptives, intrauterine device, spermicide and barrier or double barrier method) should sexual activity commence.
• A responsible adult must be available to accompany the subject to the investigational site at each visit, to provide reliable information for all study related evaluations, and to accurately and reliably dispense the study drug as directed
• Subjects must agree to be hospitalized at any time during the study, if it is deemed clinically necessary by the investigator.
• Subjects must be able to meet study requirements. If a subject is unable to read study information, study personnel may read the questions to the subject and mark his or her choices
• Subjects must meet the DSM-IV criteria for schizophrenia for at least one year. The K-SADS-PL questionnaire will be used to establish the diagnosis (including all supplements). Subjects should have had at least one adequate treatment with an antipsychotic before participation in this study.
• Parent(s) or the legal guardian(s) of the subject must have signed the informed consent form for DNA research indicating consent or refusal to participate in the DNA component of the study (where local regulations permit). Participation in this component is not required for participation in the main study
• Subjects must be otherwise physically healthy on the basis of a physical examination, medical history, ECG, and the results of clinical laboratory tests carried out within 21 days before baseline.
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· Subjects who, at screening, meet the DSM-IV criteria for dissociative disorder, bipolar disorder, major depressive disorder, schizoaffective disorder, schizophreniform disorder, autistic disorder, or primary substance-induced psychotic disorder. Other comorbid disorders e.g., attention-deficit hyperactivity disorder (ADHD) are allowed, as long as the diagnosis of schizophrenia is the primary diagnosis and the comorbid disorders in the investigator’s judgment do not require medications (See Section 8, Concomitant Therapy)
· Subjects with mild, moderate, or severe mental retardation (i.e., documented intelligence quotient [IQ] <70), established by previous IQ testing or history
· Subjects with a known or suspected history of substance dependence (including alcohol, but excluding nicotine and caffeine) according to the DSM-IV criteria in the 3 months preceding screening.
· 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, including:
– heart rate of <50 bpm for subjects between 13 to 17 years of age, inclusive, and heart rate <55 bpm for subjects less than 13 year of age.
– demonstration of repeated prolonged QTc Fridericia interval >450 msec, as measured on more than one ECG (either during screening, or from a previous medical record).
– the following cardiac conditions: sick sinus syndrome, complete AV block, congestive heart failure, polymorphic ventricular tachycardia
– clinically relevant hypocalcemia, hypokalemia, or hypomagnesemia
· Concomitant use of drugs that prolong the QTc interval (including Class A [e.g., quinidine, procainamide] or Class III [e.g., amiodarone, sotalol] antiarrhythmic medications); presence of congenital prolongation of the QT interval (Romano-Ward Syndrome, Jervell, and Lange-Nielsen syndrome)
· Female subjects who are pregnant (as confirmed by urine pregnancy test performed at screening or baseline), planning to become pregnant or are nursing
• Subjects with a known or suspected history of seizure disorder, including
neuroleptic malignant syndrome, encephalopathic syndrome, tardive
dyskinesia, or insulin dependent diabetes mellitus
• Presence of any significant or unstable cardiovascular, respiratory, renal,
hepatic, hematologic, endocrine, immunologic, or other systemic disease
• Have active and clinically relevant hypo- or hyperthyroidism unless
stabilized on appropriate medications for at least 3 months
• History of severe preexisting gastrointestinal narrowing (pathologic or
iatrogenic) or an inability to swallow oral study drug with the aid of water
• Subjects who, in the opinion of the investigator, should not discontinue or
participate in washout of prohibited concomitant psychotropic
medications (Section 8, Concomitant Therapy)
• Subjects who have received electroconvulsive therapy in the 3 months
preceding baseline
• Subjects who, despite washout, continue to use any prohibited
concomitant medication, substance of abuse, or alcohol within 5 half-lives
(up to a maximum of 5 days) before baseline, as evidenced by history or
as suggested by a positive urine drug screen at baseline
• Subjects who have received clozapine in the 2 months before the baseline
visit.
• Subjects who have received a depot antipsychotic within 2 treatment
cycles before the baseline visit
• Clinically significant abnormalities in medical history, physical
examination, ECG or bioche

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified