Amantadine Addition to Paliperidone ER or Risperidone Consta Therapy for Prolactin Elevation
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
研究概览
简要总结
The purpose of this study is to show that amantadine might help to reduce the side effect of the medications which are prescribed to treat schizophrenia or schizoaffective disorder. High level of hormone prolactin, or hyperprolactinemia, is one of the side effects which might be developed in patients treated with the paliperidone ER or risperidone Consta.
High level of prolactin might stimulate breast development, might decrease sexual desire (libido). The goals of this study are to demonstrate that amantadine lowers prolactin levels, decreases side effects, and improves psychiatric symptoms.
详细描述
Trial Description: A double-blind, placebo-controlled, prospective, randomized trial to evaluate the effects of two doses of amantadine or placebo in the management of antipsychotic-induced hyperprolactinemia and psychiatric status in patients with schizophrenia or schizoaffective disorder who are clinically stable on paliperidone ER or risperidone Consta. Placebo or amantadine 100 mg or 200 mg BID will be administered to participants for 4 consecutive weeks as an adjunctive therapy in 72 schizophrenia subjects treated with paliperidone or risperidone Consta to examine amantadine effects on fasting AM serum prolactin levels. Participants will be followed after suspension of amantadine or placebo for an additional 4 weeks for safety purposes. The goals of this study are to prospectively demonstrate that amantadine lowers prolactin levels, and evaluate the impact of amantadine on psychiatric symptoms, and on prolactin-related side effects in patients treated with paliperidone ER or risperidone Consta.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female
- •Age 18-65 years
- •Diagnosis of schizophrenia, schizoaffective disorder, any subtype or schizophreniform disorder
- •Well established compliance with out-patient medications including paliperidone ER or risperidone Consta for 3 months
排除标准
- •Current substance or alcohol abuse
- •Significant medical illness
- •Women who are pregnant, breastfeeding, or who are unwilling or unable to use an effective form of birth control during the entire study
- •Subjects treated with more than one antipsychotic drug
研究组 & 干预措施
Amantadine 100mg BID
Subjects take amantadine 100mg tablets twice per day (BID)
干预措施: Amantadine Hydrochloride, USP (Drug)
Amantadine, 200mg BID
Subjects take amantadine 200mg tablets twice per day (BID)
干预措施: Amantadine Hydrochloride, USP (Drug)
Amantadine, placebo BID
Subjects take placebo tablets twice per day (BID)
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Prolactin Levels for Individuals Treated With Adjunctive Amantadine Versus Placebo.
时间窗: week 4 and week 8
次要结局
未报告次要终点
研究者
David C. Henderson, MD
Associate Professor
North Suffolk Mental Health Association