Prazosin Use in Adults With Anxiety Disorders

Study Overview
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Brief Summary
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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.

Official Title
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Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders

Conditions
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Anxiety, Anxiety Disorders

Intervention / Treatment
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* Drug: Prazosin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Open-label treatment with Prazosin<br>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. | Drug: Prazosin<br>* Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy<br>* Other names: Minipress;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Anxiety Symptoms | The Hamilton Anxiety Rating Scale (HAM-A) consists of 14 items, each defined by a series of, and measures both psychic anxiety (mental agitation and psychological distress) and somatic anxiety (physical complaints related to anxiety). Each item is scored on a scale of 0 (not present) to 4 (severe), with a total score range of 0-56, where <17 indicates mild severity, 18-24 mild to moderate severity and 25-30 moderate to severe. | To be completed at baseline and weekly during weeks 2,3,4,5,6,7, 8 to assess changes over the last week | 
| Change in Anxiety Symptoms | 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. | To be completed at baseline and weekly during weeks 2,3,4,5,6,7,8 to assess changes over the last week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Depressive Symptoms | To examine depressive symptoms following the use of prazosin as measured by the Patient Health Questionnaire (PHQ-9).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. | To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks | 
| Change in Level of Disability | To examine levels of disability following the use of prazosin as measured by the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) | To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks | 
| Change in Overall Symptom Severity | To examine overall symptom severity following the use of prazosin as measured by the DSM-5 Self-Rated Level 1 Cross-Cutting Symptom Measure for Adults (DSM-5). | Previous 2 weeks | 
| Changes in Experienced Symptoms | To examine improvement in symptoms as measured by the Clinical Global Impression-Improvement Scale (CGI-I). Scale ranges from 1 (very much improved since initiation of treatment) to 7 (very much worse since initiation of treatment) | 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 examine the overall tolerability of prazosin by recording heart rate at each visit | 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 examine the overall tolerability of prazosin by recording blood pressure at each visit in the sitting and standing positions | To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 | 
| Side Effects | To examine the overall tolerability and side effects of prazosin by recording potential adverse symptoms using a Vital Signs and Adverse Symptoms Checklist. | To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 | 
| Change in Sleep Impairment | To examine sleep quality following the use of prazosin as measured by the Insomnia Severity Index (ISI). | Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks |