Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
试验速览
- 阶段
- 1 期
- 状态
- 暂停
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Change in Anxiety Symptoms
研究概览
简要总结
Prazosin has shown effectiveness in treating Post-Traumatic Stress Disorder through improving sleep quality and global functioning. Given the significant evidence for its utility in treating PTSD, in combination with the fact that many anxiety symptoms overlap with PTSD (e.g.insomnia, hyperarousal, and irritability), it is essential to evaluate its potential effectiveness in treating symptoms of other anxiety disorder and patient tolerability.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Existing Diagnosis of any anxiety disorder according to DSM-5 criteria (i.e. GAD, Panic Disorder, Agoraphobia, Social Phobia or Specific phobias)
- •Newly diagnosed patients or patients who are either resistant or not adherent to their current treatment are eligible to be enrolled in the study.
- •If patient is on anti-hypertensive therapy, the dose of anti-hypertensive(s) must be stable for at least 4 weeks prior to the study and blood pressure must be well controlled.
排除标准
- •Patients with comorbid condition of psychosis, a diagnosis of PTSD, an active severe substance use disorder, or actively suicidal.
- •Patients actively enrolled in psychotherapy sessions at the time of the study.
- •Patients experiencing baseline systolic blood pressure ≤100 mmHg supine, orthostatic hypotension (a decrease in systolic blood pressure from a sitting position of 20 mmHg or more after 2 minutes standing accompanied with light-headedness), or a baseline diastolic blood pressure less than 60 mmHg.
- •Pregnant or lactating women.
- •Patients with acute medical or psychiatric conditions that require immediate hospital admission.
- •Patients with a history of allergic reaction to prazosin or any of its components.
- •Patients unable to communicate in English.
- •Patients who are scheduled to undergo cataract surgery are excluded from the study until after the surgery has been completed.
研究组 & 干预措施
Open-label treatment with Prazosin
Week 1 Day 1-3: 0.5 mg at bedtime Day 4-7: 1.0 mg at bedtime Week 2 Day 8-10: 2.0 mg at bedtime Day 11-14: 4.0 mg at bedtime Week 3 2 mg in the morning, 4 mg at bedtime Week 4 4 mg in the morning, 4 mg at bedtime Week 5 4 mg in the morning, 6 mg at bedtime Week 6 4 mg in the morning, 8 mg at bedtime
Dosage of Prazosin will be titrated at the discretion of the study physician.
干预措施: Prazosin (Drug)
结局指标
主要结局
Change in Anxiety Symptoms
时间窗: To be completed at baseline and weekly during weeks 2,3,4,5,6,7,8 to assess changes over the last week
Generalized Anxiety Disorder 7 Item Scale (GAD-7) objectively determines initial symptoms severity and monitor symptom changes/effect of treatment over time. Each item is scored on a scale of "0" (not at all) to "3" (nearly every day). Scores of 5, 10, and 15 are taken as the cut-off points for mild, moderate and severe anxiety, respectively.
次要结局
- Side Effects(To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8)
- Change in Depressive Symptoms(To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks)
- Change in Overall Symptom Severity(Previous 2 weeks)
- Changes in Experienced Symptoms(Completed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to assess changes over the past week)
- Tolerability of Medication (Heart Rate)(To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to monitor changes since last visit)
- Tolerability of Medication (blood pressure)(To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8)
- Change in Level of Disability(To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks)
- Change in Sleep Impairment(Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks)