Antidepressant Induced Excessive Sweating: Measurement and Treatment With Terazosin
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 23
- 试验地点
- 1
- 主要终点
- To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
研究概览
简要总结
The study consists of measurement of antidepressant-induced excessive sweating and its treatment with an experimental medication, terazosin (approved for hypertension), that will be added to the antidepressant. This study is for people who take an antidepressant due to a depressive disorder. This is an open-label study (no placebo group) that will last 5 weeks, with one week of baseline measurement and four weeks of treatment with the study medication. The study is based on the hypothesis that terazosin will be effective in reducing the severity of excessive sweating caused by antidepressant treatment, and will have minimal side-effects.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 - 75 years
- •Clinical diagnosis of a Depressive disorder (Diagnostic and Statistical Manual of Mental Disorders - IV-TR)
- •Presence of excessive sweating by self-report
- •The excessive sweating started after initiation of an antidepressant and, if treatment with the antidepressant was interrupted, did not persist for more than 4 weeks during that interruption
- •Treatment with the antidepressant is deemed to be clinically necessary due to substantial benefit from this antidepressant, and failure to respond to or tolerate an alternative
- •Excessive sweating has persisted for at least 4 weeks prior to baseline assessment
- •The excessive sweating is rated by the patient as at least moderately bothersome.
- •Episodes of excessive sweating occur at least twice a week for last 4 weeks
排除标准
- •Presence of another known disease that could potentially cause excessive sweating
- •Failure to respond to antiadrenergic (reducing activity of the sympathetic nervous system) treatment in the past
- •Blood pressure less than 110 mm Hg systolic at the screening or baseline visits
- •Orthostatic hypotension by history or on assessment at the screening or baseline visits (defined as a decrease of 10 mm Hg or greater after standing for 2 minutes).
- •Current antihypertensive treatment
- •History of significant cardiac disease, including coronary artery disease
- •Current use of phosphodiesterase type 5 inhibitors: sildenafil (ViagraTM), tadalafil (CialisTM), or vardenafil (LevitraTM)
- •History of priapism (persistent and painful erection)
研究组 & 干预措施
terazosin
open-label treatment group
干预措施: terazosin (Drug)
结局指标
主要结局
To test a novel device for ambulatory monitoring of sweating which is required to study this phenomenon since ADIES is usually episodic
时间窗: 8 weeks
To study whether terazosin 1 to 4 mg/ day is effective in reducing antidepressant-induced sweating
时间窗: 8 weeks
次要结局
- To determine if response to treatment correlated with baseline urinary norepinephrine levels and with changes in these levels during the study.(8 weeks)
- To determine if the severity of sweating at baseline is correlated with baseline urinary norepinephrine levels(8 weeks)