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临床试验/EUCTR2010-018911-13-HU
EUCTR2010-018911-13-HU进行中（未招募）不适用

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 & Commercialization, Inc.0 个研究点目标入组 350 人开始时间: 2011年2月10日最近更新:
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试验速览

阶段
不适用
状态
进行中（未招募）
入组人数
350
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •Inclusion Criteria Assessed at Screening
  • •1. Study specific written informed consent/assent obtained from a parent/guardian or legally acceptable representative, as applicable for local laws, prior to the initiation of any protocol-required procedures. In addition, the subject must provide informed assent at screening and must be able to understand that he or she can withdraw from the study at any time. If the rollover subject should turn 18 years of age (or the age of adulthood as specified by local laws or regulations) 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:
  • •Schizophrenia:
  • •De novo subjects aged 13 to 17 years at the time of signing the informed consent/assent
  • •Rollover subjects from Study 266
  • •Bipolar Manic or Mixed Episode:
  • •De novo subjects aged 10 to 17 years at the time of signing the informed consent/assent.
  • •3. All Subjects: Co-morbid diagnoses are permitted including Attention Deficit Disorder (ADD), Attention Deficit Hyperactivity Disorder (ADHD), Conduct disorder (CD), and Oppositional Defiant Disorder (ODD) and anxiety disorders (except Post Traumatic Stress Disorder [PTSD] and Obsessive Compulsive Disorder
  • •Subjects with Schizophrenia: 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. If a rollover subject does not have a completed K-SADS-PL assessment from Study 266, then this assessment must be completed at Screening for Study 267.
  • •Subjects with Bipolar Manic or Mixed Episode: Subjects with a current diagnosis of Bipolar I Disorder, manic or mixed episode with or without psychotic features experiencing symptoms at least for a week, as defined by Axis I (DSM-IV-TR) criteria, confirmed by K-SADS-PL, and have a YMRS score = 20 at Baseline.
  • •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) 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 antipsychotics other than clozapine, and subjects are not resistant to treatment with other antipsychotics. De novo subjects who 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. Subjects who rollover from Study 266 who meet the criteria for impending relapse are exempt from this criteria.
  • •8. Ability of the

排除标准

  • •Sex and Reproductive Status
  • •ALL SUBJECTS:
  • •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, two of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device (IUD), birth control pill, birth control depot injections, 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) All Subjects: Axis I (DSM-IV-TR) diagnosis for schizoaffective disorder, autism, pervasive developmental disorder (PDD), OCD, or PTSD.
  • •Subjects with Schizophrenia: Subjects with a current major depressive episode.
  • •Subjects with Bipolar Manic or Mixed Episode:
  • •Subjects presenting with a clinical picture and/or history that is consistent with an Axis I (DSM-IV-TR) diagnosis of Bipolar II Disorder or Bipolar Disorder not otherwise
  • •specified (NOS).
  • •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.
  • •5. Any neurological disorder, with the exception of Tourette’s syndrome.
  • •6. Subjects experiencing symptoms consistent with a major depressive episode at the time of screening other than subjects diagnosed with Bipolar I Disorder Mixed Episode.
  • •7. Subjects with schizophrenia or Bipolar Manic or Mixed Episode that is considered treatment resistant to antipsychotic medication, including relapse while on adequate doses of aripiprazole, by history.
  • •8. Subjects who are currently receiving clozapine or have
  • •received clozapine, regardless of dose or duration, at any
  • •time in the past are ineligible for entry into the study.
  • •9. Subjects who have a significant risk of committing suicide based on history or routine psychiatric status examination, or who have an answer of yes” on Questions 4 or 5 on the suicidal ideation section of the baseline screening version of the C-SSR.
  • •10. Subjects who have met DSM-IV-TR criteria for substance dependence within the past 180 days prior to screening.
  • •11. Subjects who have epilepsy, a history of seizures (except for a single childhood febrile seizure or post-traumatic seizure), or a history of severe head trauma or stroke, or
  • •have a history or current evidence of other unstable
  • •medical conditions that would expose them to undue risk
  • •of a significant AE or interfere with assessments of safety or efficacy during the course of the trial, including but
  • •not limited to hepatic, renal, respiratory, cardiovascular,
  • •endocrine, neurologic, hematologic, or immunologic
  • •disease as determined by the clinical judgment of the
  • •investigator (eg, history of myocardial infarction or
  • •ischemic heart disease, arrhythmia, congestive heart
  • •failure, or cancer); subjects with a comorbid serious
  • •systemic illness that requires pharmacotherapy.
  • •12. Subject with a history of subclinical

研究者

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