A Fifteen-month, Prospective, Randomized, Active-controlled, Open-label, Flexible Dose Study of Paliperidone Palmitate Compared With Oral Antipsychotic Treatment in Delaying Time to Treatment Failure in Adults With Schizophrenia Who Have Been Incarcerated
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 450
- 主要终点
- Time to First Treatment Failure
研究概览
简要总结
The study will assess the use of paliperidone palmitate compared with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated.
详细描述
The primary objective of this study is to compare the efficacy of paliperidone palmitate with oral antipsychotic treatment in delaying time to a protocol-defined treatment failure over 15 months, in patients diagnosed with schizophrenia who have been incarcerated. Protocol-defined treatment failure is defined as arrest, psychiatric hospitalization, increase in psychiatric services to prevent imminent hospitalization, discontinuation of antipsychotic treatment due to inadequate efficacy, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to safety or tolerability or completed suicide. Protocol was amended on March 15, 2011 to reflect changes in the inclusion/exclusion criteria as well as the study objectives. Patients will receive either paliperidone palmitate 78, 117, 156, or 234 mg monthly by injection for fifteen months OR oral aripiprazole, haloperidol, olanzapine, paliperidone, perphenazine, quetiapine, and risperidone at doses selected by the study doctor.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Must be able to understand and sign the informed consent form approved by the Institutional Review Board (IRB)
- •Must successfully answer all the questions on the Informed Consent quiz indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study
- •Have a current diagnosis of schizophrenia
- •Taking no more than 1 oral antipsychotic on the day before randomization
- •Have been placed into custody at least twice with one of them leading to incarceration within the 24 months previous to study start, with the last release occurring within the 90 days before the first day of screening
- •in the opinion of the investigator, may benefit from a change in their prior antipsychotic treatment
- •Have available a designated individual (eg, family member, case manager, significant other, probation/parole officer) who has knowledge of the patient and is generally aware of the patient's daily activities, and who agrees to let the study site personnel know of changes in the patients circumstances when the patient is not able to provide this information, ie, arrests, protocol-defined hospitalizations, emergency room visits, becoming homeless, etc.
- •Have either an address or phone number where they can be reached, or be accessible to the designated individual
- •Must agree to receive regular injections for 15 months if randomly assigned to the paliperidone palmitate treatment group, or continue with oral study medication treatment for 15 months if randomly assigned to the oral antipsychotic treatment group
- •Women must be postmenopausal (for at least 2 years), surgically sterile (hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy), abstinent, or if sexually active, be practicing a highly effective method of birth control
排除标准
- •Allergies, hypersensitivity (anaphylaxis-type reaction), or intolerance to risperidone or paliperidone
- •Actively abusing intravenous drugs within the past 3 months or have an opiate dependence disorder
- •Have a positive urine drug screen test for barbiturates, cocaine, amphetamines, or opiates at screening
- •Women who are pregnant or breast-feeding, or planning to become pregnant
- •Have received injectable antipsychotic treatment within 2 injection cycles prior to screening
- •Received treatment with clozapine within 3 months of screening
- •Are at a high risk of violence in the next 15 months, in the opinion of the investigator
- •who have a history of sex offenses including felony sex offenses, child molestation
研究组 & 干预措施
001
paliperidone palmitate 78 117 156 or 234 mg monthly injection for 15 months
干预措施: paliperidone palmitate (Drug)
002
aripiprazole flexible dosing as prescribed by the study doctor for 15 months
干预措施: aripiprazole (Drug)
003
haloperidole flexible dosing as prescribed by the study doctor for 15 months
干预措施: haloperidole (Drug)
004
olanzapine flexible dosing as prescribed by the study doctor for 15 months
干预措施: olanzapine (Drug)
005
paliperidone flexible dosing as prescribed by the study doctor for 15 months
干预措施: paliperidone (Drug)
006
perphenazine flexible dosing as prescribed by the study doctor for 15 months
干预措施: perphenazine (Drug)
007
quetiapine flexible dosing as prescribed by the study doctor for 15 months
干预措施: quetiapine (Drug)
008
risperidone flexible dosing as prescribed by the study doctor for 15 months
干预措施: risperidone (Drug)
结局指标
主要结局
Time to First Treatment Failure
时间窗: From date of randomization up to Month 15
Time to first treatment failure was the time from participant randomization to the first treatment failure, which was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event.
Percentage of Participants in Each Event Category of First Treatment Failure
时间窗: From date of randomization up to Month 15
First treatment failure was a composite endpoint consisting of any of the following events: arrest/incarceration, psychiatric hospitalization, discontinuation (D/C) of antipsychotic treatment due to safety or tolerability, treatment supplementation with another antipsychotic due to inadequate efficacy, discontinuation of antipsychotic treatment due to inadequate efficacy, increase in level of psychiatric services to prevent imminent psychiatric hospitalization, suicide. A Treatment Failure Event Monitoring Board (EMB), blinded to individual participant treatment assignment, determined the occurrence and date of the first treatment failure event. Percentage of participants who experienced treatment failure due to any event and for each specific category of event were assessed.
次要结局
- Time to First Psychiatric Hospitalization(From date of randomization up to Month 15)
- Change From Baseline in Clinical Global Impression - Severity (CGI-S) Score During Overall Treatment Duration(Baseline up to Month 15)
- Change From Baseline in Personal and Social Performance (PSP) Total Score During Overall Treatment Duration(Baseline up to Month 15)
- Time to First Psychiatric Hospitalization or Arrest/Incarceration(From date of randomization up to Month 15)