A 52-week, Multicenter, Open-label Study to Evaluate the Effectiveness of Aripiprazole Intramuscular Depot as Maintenance Treatment in Patients With Schizophrenia
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,081
- 试验地点
- 1
- 主要终点
- Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
研究概览
简要总结
To evaluate the overall effectiveness of aripiprazole intramuscular (IM) depot as maintenance treatment in patients with schizophrenia.
详细描述
This will be an open-label, uncontrolled study which will enroll subjects from Phase 4 of Study 31-07-246 and Phase 3 of Study 31- 07-247 and new subjects not participating in Studies 246/247. The treatment history of subjects prior to enrollment in the open-label study will vary according to the design of the pivotal double-blind study (i.e., 31-07-246 or 31-07-247).
This open-label study will be comprised of phases similar to the pivotal double-blind studies (i.e., Studies 246/247): a screening phase (if applicable), a conversion phase (Phase 1, if applicable), an oral stabilization phase (Phase 2), and an IM depot open-label maintenance phase (Phase 3). Phase 3 will be a 52-week treatment period with a 26-week follow-up period.
During Phase 3 (the open-label maintenance phase) oral aripiprazole rescue medication will be allowed for subjects who do not meet stability criteria or meet the criteria for impending relapse/exacerbation of psychotic symptoms.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are able to provide written informed consent and/or consent obtained from a legally acceptable representative (as require by IRB/IEC), prior to the initiation of any protocol-required procedures.
- •Male and female subjects 18 to 65 years of age, inclusive, at time of informed consent.
- •Subjects who complete Studies 246/247 or who withdrew from the double-blind maintenance phase of either study (Phase 4 of Study 246 or Phase 3 of Study 247), or new subjects not participating in Studies 246/
- •# Subjects who, in the investigator's judgment, require chronic treatment with an antipsychotic medication.
- •Subjects able to understand the nature of the study and follow protocol requirements, including the prescribed dosage regimens, tablet ingestion, IM depot injection, discontinuation of prohibited concomitant medications, who can read and understand the written word in order to complete patient-reported outcomes measures, and who can be reliably rated on assessment scales.
排除标准
- •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 with schizophrenia that are considered resistant/refractory to antipsychotic treatment by history or response only to clozapine.
- •Subjects with a significant risk of violent behavior or a significant risk of committing suicide based on history or investigator's judgment.
- •Subjects who currently meet DSM-IV-TR criteria for substance dependence; including alcohol and benzodiazepines, but excluding caffeine and nicotine, or two positive drug screens for cocaine.
- •Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
- •Subjects with a history of hypersensitivity to antipsychotic agents.
- •Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia at screening.
研究组 & 干预措施
1
Active Treatment of aripiprazole IM depot (300mg or 400mg)
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Percentage of Stable Participants at Baseline Who Remained Stable at Endpoint (Last Visit).
时间窗: Baseline to Week 52/Last visit
"Stable" was defined as meeting all of the following criteria: Outpatient status; Positive and negative syndrome scale (PANSS) total score ≤ 80; Lack of specific psychotic symptoms on the PANSS as measured by a score of ≤ 4 on each of the following items (possible scores of 1 to 7 for each item): 1) conceptual disorganization 2) suspiciousness 3) hallucinatory behavior 4) unusual thought content; Clinical Global Impression of Severity (CGI-S) ≤ 4 (moderately ill); and Clinical Global Impression for Severity of Suicidality (CGI-SS) ≤ 2 (mildly suicidal) on Part 1 and ≤ 5 (minimally worsened) on Part 2. The percentage of stable participants at baseline who remain stable at endpoint (last visit) is described here.
次要结局
- Percentage of Participants Meeting Exacerbation of Psychotic Symptoms/Impending Relapse Criteria.(Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48,52, and Last visit (upto 4 weeks ± 3 days after completion or withdrawal))
- Percentage of Participants Achieving Remission.(Overall remission from Weeks 2,4,8,12,16,20,24,28,32,36,40,44,48 and 52)
- Percentage of Participants Stable at Baseline and Remaining Stable at Week 28.(Baseline to Week 28)
- Percentage of Participants With Time to First Exacerbation of Psychotic Symptoms/Impending Relapse.(Baseline to Week 52)
- Mean Change From Baseline to Endpoint (Last Visit) in Positive and Negative Syndrome Scale (PANSS) Total Score.(Baseline, Weeks 12, 24, 52 and last visit)
- Mean Change From Baseline in Clinical Global Impression of Severity (CGI-S) Score.(Baseline, Weeks 12, 24, 52 and last visit)
- Mean Change From Baseline to Endpoint in PANSS Positive and Negative Subscales.(Baseline, Weeks 12, 24, 52 and last visit)
- Mean Clinical Global Impression of Improvement (CGI-I) Score.(Weeks 2, 4, 12, 24, 52 and last visit)
- Percentage of Participants Who Discontinued Due to All Causes.(Baseline to Week 52)