A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study of Paliperidone Palmitate Evaluating Time to Relapse in Subjects With Schizoaffective Disorder
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 520
- 试验地点
- 14
- 主要终点
- Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period
研究概览
简要总结
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to evaluate the efficacy and safety of paliperidone palmitate, as monotherapy or as an adjunct to mood stabilizers or antidepressants, relative to placebo in delaying the time to relapse in patients with schizoaffective disorder. The study will consist of 4 periods: Screening (up to 7 days), Open-Label Flexible Dose Lead-in (13 weeks), Open-Label Fixed Dose Stabilization (12 weeks), and Double-Blind Relapse Prevention (15 months). Approximately 520 subjects (approximately 126 in India) are to be enrolled in the open-label Lead-in Period in the USA, Bulgaria, Malaysia, Philippines, Romania, Russia, Ukraine, South Africa and India. Of these 520 subjects, it is expected that approximately 286 subjects will qualify to enter the double-blind Relapse Prevention Period. Efficacy will be evaluated during the study using a relapse assessment, the Positive and Negative Symptom Scale (PANSS), the Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA), the Personal and Social Performance Scale (PSP), the Young Mania Rating Scale (YMRS), and the Hamilton Rating Scale for Depression (HAM-D). Safety will be assessed throughout the study by monitoring of adverse events, clinical laboratory tests, electrocardiograms (ECGs), vital sign measurements (temperature, pulse, and blood pressure), weight, and the monitoring of extrapyramidal symptoms using the Extrapyramidal Symptom Rating Scale-Abbreviated (ESRS-A). Suicidality will be assessed by the Columbia Suicide Severity Rating Scale (C-SSRS). The tentative date of enrollment of first patient in India is January 25, 2011.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •DSM-IV diagnosis of schizoaffective disorder.
- •Experiencing an acute exacerbation of psychotic symptoms.
- •A score of more than or equual to 4 on at least 3 of the following 7 PANSS items: Delusions (P1), Hallucinatory behavior (P3), Excitement (P4), Hostility (P7), Tension (G4), Uncooperativeness (G8), and Poor Impulse Control (G14).
- •A score of more than or equual to 16 on YMRS and/or a score of more than or equual to 16 on the HAM-D-
- •Healthy based on physical examinations, electrocardiogram (ECG), laboratory tests, medical history, and vital signs measurements.
排除标准
- •A primary active mental illness diagnosis other than schizoaffective disorder- Have attempted suicide within 12 months or are at imminent risk of suicide or violent behavior- Subjects with first episode of psychosis- Received electroconvulsive therapy in the past 3 months- History of hypersensitivity to or intolerance of paliperidone, risperidone, or 20% Intralipid (placebo)- Received long-acting antipsychotic medication within 2 injection cycles- Received therapy with clozapine within 3 months- A history of neuroleptic malignant syndrome- Previous history of lack of response to antipsychotic medication- Subjects receiving therapy with antidepressants or mood stabilizers that has been initiated and/or changed in dose <30 days prior to screening- Receiving therapy with carbamazepine- Receiving therapy with monoamine oxidase inhibitors- Pregnant, breast-feeding, or planning to become pregnant.
结局指标
主要结局
Time between subject randomization to treatment and the first occurrence of a relapse during the Relapse Prevention Period
时间窗: Monthly during the 15 month double-blind Relapse Prevention Period
次要结局
- Symptom change as measured by the Positive and Negative Syndrome Scale (PANSS) total and PANSS factor scores(Up to 15 Months)
- Illness severity change as measured by Clinical Global Impression of Severity for Schizoaffective Disorder (CGI-S-SCA)(Up to 15 Months)
- Change in subject functioning using the Personal and Social Performance Scale (PSP)(Up to 15 Months)
- Change in subject medication satisfaction using the Medication Satisfaction Questionnaire (MSQ)(Up to 15 Months)
- Change in mood symptoms as measured by YMRS (in subjects with YMRS=16 at enrollment) and HAM-D-21) (in subjects with HAM-D-21=16 at enrollment)(Up to 15 Months)