NCT01552772已完成1 期
An Open-label, Safety and Tolerability Trial of Aripiprazole IM Depot Treatment Initiation in Adult Subjects With Schizophrenia Stabilized on Atypical Oral Antipsychotics Other Than Aripiprazole
Otsuka Pharmaceutical Development & Commercialization, Inc.10 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Number of Participants With Adverse Events (AE).
研究概览
简要总结
This study will test the safety of an aripiprazole injection in subjects with schizophrenia that are currently taking oral antipsychotic medication other than aripiprazole. Subjects in this study will receive one injection of aripiprazole and will need to stop taking their other antipsychotic medication two weeks after the injection. The study will last one month. Subjects will be required to come to a clinic for evaluations and drug and urine collection five times during the course of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female individuals between 18 and 64 years of age, inclusive, with a diagnosis of schizophrenia as defined by DSM-IV-TR criteria.
- •Good physical health as determined by no clinically significant deviation from normal in medical history, clinical laboratory determination, ECGs, or physical examinations.
- •Ability to provide written informed consent or consent obtained from a legally acceptable representative (as required by IRB) prior to the initiation of any protocol-required procedures.
- •Body mass index of 18 to 35 kg/m2, inclusive.
- •Prior history of tolerating aripiprazole.
- •Subjects must be treated with one of the following atypical oral antipsychotic medications: risperidone, olanzapine, quetiapine, ziprasidone, or paliperidone and be clinically stable, per the investigator's judgment, for 14 days prior to the administration of aripiprazole IM depot
排除标准
- •Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or have not had an orchidectomy or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide. Note: Women of childbearing potential (WOCBP) are defined as all women unless they have had an oophorectomy or hysterectomy or have been postmenopausal for 12 consecutive months.
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine. Subjects with a positive drug screen for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana).a
- •Subjects likely to require prohibited concomitant therapy during the trial, and use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days prior to dosing and for the duration of the trial.
- •Females who are pregnant or lactating.
- •Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous IM depot trial within the last 6 months; or who had previously enrolled and received trial medication in an aripiprazole IM depot clinical trial.
- •Any major surgery within 30 days prior to enrollment.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical, electrocardiographic, or clinical laboratory examinations.
- •Subjects who have a significant risk of committing suicide based on history or routine psychiatric status examination
- •Subjects currently in an acute relapse of schizophrenia.
- •Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
- •Subjects who were considered treatment-resistant to antipsychotic medication. (Subjects needed to have shown a previous response to an antipsychotic medication other than clozapine.)
- •Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia.
- •Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
研究组 & 干预措施
Aripiprazole IM Depot
Experimental
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AE).
时间窗: From the time the informed consent (ICF) was signed until follow-up at 30 days after the last trial visit (Day 28).
An AE was defined as any new medical problem, or exacerbation of an existing problem, experienced by a participant while enrolled in the trial, whether or not it was considered drug related by the study physician. A serious adverse event (SAE) was any untoward medical occurrence that resulted in death or was life-threatening or required inpatient hospitalization or prolonged hospitalization. TEAE stands for treatment emergent adverse events.
次要结局
- Change From Baseline in PANSS Positive Sub-scale Score for OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
- Change From Baseline in PANSS Positive Sub-scale Score for LOCF Data.(Baseline, Week 1, 2 and 4)
- Change From Baseline in PANSS Negative Sub-scale Score for LOCF Data.(Baseline, Week 1, 2 and 4)
- Change From Baseline in Total Score of PANSS for Last Observation Carried Forward (LOCF) Data.(Baseline, Week 1, 2 and 4)
- Change From Baseline in Total Score of Positive and Negative Syndrome Scale (PANSS) for Observed Cases (OC) Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
- Change From Baseline in PANSS Negative Sub-scale Score for OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
- Change From Baseline in Clinical Global Impression Severity (CGI-S) Score in OC Data.(Baseline, Week 1, 2, 4 and Last visit (Day 28).)
- Change From Baseline in CGI-S Score in LOCF Data.(Baseline, Week 1, 2 and 4.)
- CGI-I Scale Score in LOCF Data.(Week 1, 2 and 4)
- Clinical Global Impression Improvement (CGI-I) Scale Score in OC Data.(Week 1, 2, 4 and Last visit (Day 28).)
研究者
研究点 (10)
Loading locations...
相似试验
已完成
3 期
Aripiprazole Oral Acceptability TrialSchizophreniaNCT00101569Otsuka Pharmaceutical Development & Commercialization, Inc.59
已完成
不适用
Efficacy and Safety of Aripiprazole in Patients With Schizophrenia or Bipolar DisorderSchizophreniaBipolar DisorderNCT00216723Korea Otsuka Pharmaceutical Co., Ltd.3,000
终止
4 期
Best Event Schizophrenia Trial--A Randomized Double-Blind Trial of Aripiprazole and Risperidone in SchizophreniaSchizophreniaNCT00712270Kettering Health Network21
已完成
4 期
Effect on Cognitive Function of a Treatment With AripiprazoleSchizophreniaNCT00329810Otsuka Pharmaceutical Development & Commercialization, Inc.500
已完成
4 期
Aripiprazole for the Treatment of Schizophrenia With Co-Morbid Social AnxietySchizophreniaSchizoaffective DisorderSocial Anxiety DisorderNCT00177008University of Medicine and Dentistry of New Jersey18