Open-label Study to Assess Hospitalization Rates in Adult Schizophrenic Patients Treated With Oral Antipsychotics for 6 Months and IM Depot Aripiprazole for 6 Months, Respectively, in a Naturalistic Community Setting, Europe, Canada and Asia
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 30
- 主要终点
- Comparison of Inpatient Psychiatric Hospitalization Rates
研究概览
简要总结
The purpose of this study is to compare retrospective hospitalization rates of schizophrenic patients treated with oral antipsychotics to prospective hospitalization rates of these patients treated with IM depot aripiprazole.
详细描述
Nonadherence to antipsychotic medications remains a frequent cause of relapse among patients with schizophrenia, increasing hospitalization rates, hospitalization days, and hospitalization costs. Among hospitalized adults, schizophrenia is the fourth most commonly diagnosed illness and has the seventh longest mean duration of hospital stay in the US. Frequent relapses and hospitalization can affect quality of life in these patients. Long-acting injections (intramuscular depot) antipsychotic medication is a means to treatment adherence and increased quality of life for patients with schizophrenia.
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. If the Institutional Review Board (IRB) requires consent by a legally acceptable representative in addition to the subject, all required consents must be obtained prior to any protocol-required procedure.
- •Male and female subjects 18 to 65 years of age, inclusive
- •Current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders (DSM-IV-TR) criteria and a history of the illness for at least 1 year (12 months)
- •Subjects who in the investigator's judgment would benefit from extended treatment with a long-acting injectable formulation
- •Subjects who have at least 1 inpatient psychiatric hospitalization in the 2 years (24 months) prior to screening, but have been managed as outpatients for the 4 weeks prior entering the study
- •Subjects must have been on oral antipsychotic treatment for the full 7 months prior to the screening phase Subjects who have shown response to previous antipsychotic treatment.
- •Subjects who understand the nature of the trial and are able to follow the protocol requirements.
排除标准
- •Prisoners or subjects who are compulsorily detained (involuntarily incarcerated), or have been incarcerated in the past 7 months for any reason must not be enrolled into this trial.
- •Subjects who may require potent CYP2D6 or CYP3A4 inhibitors or CYP3A4 inducers during the trial.
- •Any subject who requires or may need any other antipsychotic medications during the course of the trial, other than allowed rescue medication.
- •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 deemed intolerant of receiving injectable treatment.
- •Subjects who have received electroconvulsive therapy within the last 7 months prior to screening.
- •Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
- •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 requiring hospitalization for any psychiatric reason during the 4 weeks prior to signing the Informed Consent Form (ICF) or during the screening period.
- •Subjects without at least 1 inpatient psychiatric hospitalization in the last 2 years (24 months) prior to screening.
- •Subjects who have met DSM-IV-TR criteria for any significant substance use disorder within 3 months prior to screening.
- •Subjects who are considered treatment-resistant to antipsychotic medication other than clozapine.
- •Treatment with long-acting injectable antipsychotics in which the last dose was within 7 months prior to screening.
- •Subjects who have not been treated with oral antipsychotics for 7 months prior to screening.
- •Subjects who have a significant risk of committing suicide
- •Subjects who have a history or evidence of a medical condition that would expose them to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the course of the trial
- •Sexually active males and females who will not commit to utilizing birth control during the trial and for up to 180 days following the trial.
- •Abnormal laboratory or physical examination results indicating a condition which may interfere with the results of the study or pose a safety risk to the subject.
- •Subjects who have previously enrolled in an aripiprazole IM depot clinical study or who have participated in any clinical trial with an investigational agent within the past 30 days.
研究组 & 干预措施
Aripiprazole IM depot injection
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary.
干预措施: Aripiprazole (Abilify®) IM Depot Injection (Drug)
Aripiprazole IM depot injection
Patients who had no history of tolerability to oral aripiprazole received 10-15 mg/day (up to 30 mg/day) oral aripiprazole for 1 to 4 weeks to determine tolerability in the Tolerability Assessment Phase prior to receiving treatment with aripiprazole IM Depot. In the Open-label Aripiprazole IM Depot Phase, participants received aripiprazole intramuscular (IM) Depot 400 mg injection (dosage could be adjusted to 300 mg at the investigator's discretion) monthly in the clinic for a total of 6 injections + concomitant oral aripiprazole 10-15 mg/day for the first 14 days. Participants at the investigator's discretion were eligible to continue to receive aripiprazole IM depot (400 or 300 mg) injection monthly in the Open-label Aripiprazole IM Depot Extension phase. Oral aripiprazole was available as rescue medication if necessary.
干预措施: Oral aripiprazole (Drug)
结局指标
主要结局
Comparison of Inpatient Psychiatric Hospitalization Rates
时间窗: Retrospective period Months 4-6; Prospective period Months 4-6
The comparison of inpatient psychiatric hospitalization rates (proportion of patients with ≥1 inpatient psychiatric hospitalizations) between the retrospective period Months 4-6 (Weeks-12 to -24) while on oral standard of care antipsychotic treatment and the prospective period Phase B Months 4-6 (Weeks 12 to 24) after the switch to aripiprazole IM depot.
次要结局
- Change From Baseline in the Positive and Negative Syndrome Scale (PANSS) Total Score(Baseline, Week 24)
- Change From Baseline in PANSS Positive and Negative Subscale Scores(Baseline, Week 24)
- Clinical Global Impression of Severity (CGI-S) Score(Baseline, Week 24)
- Clinical Global Impression of Improvement (CGI-I) Score(Baseline, Week 24)