Health Condition 1: null- Screening of Schizophrenia in Adolscent Patient
Conditions
Interventions
Intervention1: Aripiprazole: Treatment in Adolescent aripiprazole monotherapy at a dose of 10 to 30 mg/day can enter Phase 2 on their
current dose of aripiprazole after completing the
screening period
Sponsors
Otsuka Pharmaceutical Development and Commercialization Inc
Covance India Pharmaceutical Services Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Study specific written informed consent/assent obtained from a legally acceptable representative (eg, guardian), prior to the initiation of any protocol-required procedures. In addition, the subject must provide informed assent at screening and as such must be able to understand that he or she can withdraw from the study at any time. All informed consent/assent procedures must be in accordance with the study center?s institutional review board/ethics committee (IRB/IEC) and local regulatory requirements. If the roll-over subject should turn 18 years of age within 4 weeks prior to entry into Study 267 or during Study 267 participation, an informed consent must be obtained from the subject. 2) Adolescent male and female subjects including: ? De novo subjects aged ≥ 13 to subject must have passed his or her 13th birthday but not yet reached their 17th birthday at the time of signing the informed consent/assent) ? Rollover subjects from Study 266 3) Subjects with a current diagnosis of schizophrenia, as defined by DSM-IV-TR criteria (and confirmed by the K-SADS-PL for de novo subjects only), and a history of the illness (diagnosis or symptoms) for at least 6 months prior to screening (as per subject, family, or healthcare provider, or by previous medical records). Schizophrenia must be the primary DSM-IV-TR axis I diagnosis. The diagnosis of schizophrenia must be made and documented initially by an adequately trained clinician (eg, adolescent psychiatrist or local medical equivalent). For de novo subjects, the diagnosis should be confirmed by utilizing the K-SADS-PL performed by an adequately trained clinician once at the time of the entry into Study 267. Rollover subjects could use K-SADS-PL collected during Study 266. 4) Subjects who, in the investigator?s judgment, require treatment with antipsychotic medication(s). 5) Subjects who have shown previous response to antipsychotic treatment (other than clozapine unless clozapine is the only available treatment) and are not resistant to treatment with other antipsychotics, according to the investigator?s clinical judgment. 6) Subjects who are currently being treated with oral or depot antipsychotics other than clozapine, unless clozapine is the only available treatment and subjects are not resistant to treatment with other antipsychotics. De novo subjects who recently have been without antipsychotic treatment (for no more than 3 weeks) prior to screening will be considered as being treated currently for the purpose of determining eligibility for this trial. 7) Inpatient or outpatient status, with the exception of acute hospitalization due to psychiatric reasons at the time of screening or before Phase 2. 8) Ability of the subject and the subject?s legally acceptable representative (eg, guardian) or caregiver(s) to comprehend and satisfactorily comply with the protocol requirements (including the prescribed dosage regimens, tablet ingestion, and discontinuation of prohibited concomitant medications), to read and understand the written word in order to complete subject-reported
Exclusion criteria
Exclusion criteria: 1) Sexually active males who are not practicing doublebarrier birth control or who will not remain abstinent during the study and for 90 days following the last dose of study medication, or sexually active females of childbearing potential who are not practicing doublebarrier birth control or who will not remain abstinent during the study and for 30 days following the last dose of study medication. Abstinence will be permitted if it is confirmed and documented at every study visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill,implant, condom or sponge with spermicide. 2) Females who are breast-feeding and/or who have a positive serum pregnancy test result prior to receiving study drug. Target Disease 3) Patients with and Axis I (DSM-IV-TR) diagnosis for schizoaffective disorder, or a current diagnosis of major depressive disorder. 4) Subjects with a clinical presentation and/or history that is consistent with delirium, dementia, amnesia or other cognitive disorders; subjects with psychotic symptoms that are better accounted for by another general medical condition(s) or direct effect of a substance (ie, medication,illicit drug use, etc.). 5) Any neurological disorder, with the exception of Tourette?s syndrome. 6) Subjects experiencing acute depressive symptoms within the past 30 days prior to screening that require treatment with an antidepressant, according to the investigator?s judgment. 7) Subjects with schizophrenia that is Considered treatment resistant to antipsychotic medication, including relapse while on adequate doses of aripiprazole, by history. 8) Subjects with a history of failure of clozapine treatment or response to clozapine treatment only.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The frequency and severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to AEs Timepoint: Screening Visit Baseline visit Weekly visit Phase 1 Wk 1 - Phase 1 wk 6 Phase 2 Baseline visit Weekly visit Phase 2 Wk 1 - Phase 2 wk 4 Biweekly visit Phase 2 week 6 , Phase 2 wk 8 Months 3, 4 ,6,9,12,15,18,21 Visit Months 5, 7, 8, 10, 11, 13,14, 16, 17, 19, 20,22, 23 Phone Contact End of Study (Month 12 or 24) | — |
Secondary
| Measure | Time frame |
|---|---|
| Mean change from baseline and incidence of clinically significant abnormalities in clinical laboratory tests and urinalysis results (including fasting blood lipids, glucose and insulin, serum prolactin, hemoglobin A1c [HbA1c] and creatinine phosphokinase [CPK]), vital signs (supine and standing positions) and ECG parameters. A central ECG service will be utilized to review all ECGs in order to standardize interpretations for the safety analysis â?¢ Review of physical examination findingsTimepoint: 2.5 YEARS | — |
Countries
Australia, Bulgaria, China, Germany, India, Philippines, Thailand, United Kingdom
Contacts
Public ContactMr Ulhas Shinde
Covance India Pharmaceutical Services Pvt. Ltd.
Outcome results
None listed