A Clinical Trial to evaluate the safety and Tolerability of Treatment in Adolscent patients with Schizophrenia.
- Conditions
- Health Condition 1: null- Screening of Schizophrenia in Adolscent Patient
- Registration Number
- CTRI/2012/09/002953
- Lead Sponsor
- Otsuka Pharmaceutical Development and Commercialization Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 250
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 < 17 years (ie,
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
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The frequency and severity of AEs, SAEs (clinical and laboratory), and discontinuation from study due to AEs <br/ ><br>Timepoint: Screening Visit <br/ ><br>Baseline visit <br/ ><br> <br/ ><br>Weekly visit Phase 1 Wk 1 - Phase 1 wk 6 <br/ ><br> <br/ ><br>Phase 2 <br/ ><br>Baseline visit <br/ ><br> <br/ ><br>Weekly visit Phase 2 Wk 1 - Phase 2 wk 4 Biweekly visit Phase 2 week 6 , Phase 2 wk 8 <br/ ><br>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) <br/ ><br>
- Secondary Outcome Measures
Name Time Method Mean change from baseline and incidence of clinically significant <br/ ><br>abnormalities in clinical laboratory tests and urinalysis results (including <br/ ><br>fasting blood lipids, glucose and insulin, serum prolactin, hemoglobin A1c <br/ ><br>[HbA1c] and creatinine phosphokinase [CPK]), vital signs (supine and <br/ ><br>standing positions) and ECG parameters. A central ECG service will be <br/ ><br>utilized to review all ECGs in order to standardize interpretations for the <br/ ><br>safety analysis <br/ ><br>â?¢ Review of physical examination findingsTimepoint: 2.5 YEARS