Treatment Effects of Escitalopram (Lexapro®) on Generalized Anxiety Disorder, Adherence to Antiretroviral Therapy,Cognition, and Immune Status Among Patients With HIV and AIDS: A 6-week Open-label, Prospective, Pilot Trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
研究概览
简要总结
The purpose of this study is to evaluate whether escitalopram is safe, well tolerated, and effective in the treatment of HIV-infected patients with generalized anxiety disorder.
详细描述
Anxiety disorders are twice as prevalent among HIV-infected patients as they are in the general population. Approximately 25%-40% of HIV-infected patients have anxiety disorders; Generalized Anxiety Disorder, Panic disorder and post-traumatic Stress Disorder being the most frequent. Non-adherence to anti-retroviral medications is commonly seen in patients with HIV with GAD.The role of specific selective serotonin reuptake (SSRIs) in the treatment of HIV-patients with GAD is unclear. Escitalopram has been used in the treatment of GAD in the general population. It has been shown to be safe in HIV-patients with a tolerable side-effect profile. However, whether it can improve GAD in HIV-infected patients has not yet been investigated.
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
- •age 18 to 65 years,
- •DSM-IV (Diagnostic and Statistical Manual of Mental Disorders) criteria for Generalized Anxiety Disorder
- •confirmed stable HIV disease and attending a HIV treatment program
- •stable dose of highly active anti-retroviral therapy for a minimum of 4 weeks
- •ability to give informed consent
排除标准
- •bipolar disorders, any psychotic disorder
- •current major depression
- •substance dependence (except nicotine dependence) in the previous 3 months
- •currently suicidal or high suicide risk, serious or unstable medical disorders (e.g. uncontrolled hypertension or diabetes)
- •any hospitalization for HIV-related illness in the previous 3 months
- •any active CNS (central nervous system) CNS opportunistic infection or CNS malignancies related to HIV
- •current active treatment for opportunistic infections related to HIV
- •any psychotropic drug treatment in the previous 2 weeks before screening
- •history of hypersensitivity to escitalopram and/or citalopram
- •admission BDI 23
- •seizure disorder, traumatic brain injury
- •pregnant, nursing mother or planning to get pregnant.
- •Concomitant mediations: At least 2-week washout of antidepressant (4 weeks for fluoxetine) or antipsychotic or anti-anxiety medications.
- •In the opinion of the investigator the clinical condition precludes participation in the trial.
研究组 & 干预措施
Escitalopram
Treatment effects of Escitalopram in Generalized Anxiety Disorder in patients with HIV/AIDS.Open label, rater-blinded, prospective, 6-week trial of escitalopram.Subjects received escitalopram 10-20mg. Escitalopram was started at 10mg per day and augmented weekly in 10mg per day increments, the maximum dose being 20mg per day.
干预措施: Escitalopram (Drug)
结局指标
主要结局
Change From Randomization to End of Treatment in Scores on the Hamilton Anxiety Rating Scale (HAM-A)
时间窗: baseline and 7 weeks
The HAM-A is administered by an interviewer who asks a series of questions related to symptoms of anxiety. The interviewer then rates the individual on a five-point scale for each of the 14 items. Seven of the items specifically address psychic anxiety and the remaining seven items address somatic anxiety. The total anxiety score ranges from 0 to 56, lower scores are better. Change from randomization to end of treatment in scores on the Hamilton Anxiety Rating Scale (HAM-A)is measured.
Changes From Randomization to End of Treatment in Scores on the Beck Depression Inventory
时间窗: baseline and 7 weeks
Scoring The BDI consist of twenty-one questions about how the subject has been feeling in the last week. Each question has a set of at least four possible answer choices, ranging in intensity as follows: (0) I do not feel sad. 1. I feel sad. 2. I am sad all the time and I can't snap out of it. 3. I am so sad or unhappy that I can't stand it. A value of 0 to 3 is assigned for each answer and the total score is compared to a key to determine the depression's severity. The standard cut-offs are as follows:\[6\] 0-9: indicates minimal depression 10-18: indicates mild depression 19-29: indicates moderate depression 30-63: indicates severe depression. Higher total scores indicate more severe depressive symptoms.
次要结局
- Change From Randomization to End of Treatment in Scores for the Clinical Global Impression(CGI-S and CGI-I)(baseline and 7 weeks)
- Change From Randomization to End of Treatment for Trail Making Tet (TMT)(baseline to 7 weeks)
- Changes From Randomization to End of Treatment in Scores on the Mini Mental State Examination (MMSE)(baseline and 7 weeks)
- Changes From Randomization to End of Treatment in Scores on the Sheehan Disability Scores (SDS)(baseline and 7 weeks)