CTRI/2012/09/002953已完成4 期
A Long-term, Multicenter, Open-Label Study to Evaluate the Safety and Tolerability of Flexible-Dose Oral Aripiprazole (OPC- 14597) as Maintenance Treatment in Adolescent Patients with Schizophrenia or Child and Adolescent Patients with Bipolar I Disorder, Manic or Mixed Episode with or without Psychotic Features - ATTAI
Otsuka Pharmaceutical Development and Commercialization Inc0 个研究点目标入组 250 人开始时间: 待定最近更新:
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •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
- 另有 8 项未显示
排除标准
- •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
- •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.
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