Prazosin Use in Adults With Anxiety Disorders

University of Manitoba

Status and phase: Suspended; Phase 1

Conditions: Anxiety Disorders; Anxiety

Treatments: Drug: Prazosin

Study type: Interventional

Funder types: Other

Identifiers

NCT03894345

HS21444 (B2018:002) PRA2051N

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Existing Diagnosis of any anxiety disorder according to DSM-5 criteria (i.e. GAD, Panic Disorder, Agoraphobia, Social Phobia or Specific phobias)
2. Newly diagnosed patients or patients who are either resistant or not adherent to their current treatment are eligible to be enrolled in the study.
3. 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

1. Patients with comorbid condition of psychosis, a diagnosis of PTSD, an active severe substance use disorder, or actively suicidal.
2. Patients actively enrolled in psychotherapy sessions at the time of the study.
3. 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.
4. Pregnant or lactating women.
5. Patients with acute medical or psychiatric conditions that require immediate hospital admission.
6. Patients with a history of allergic reaction to prazosin or any of its components.
7. Patients unable to communicate in English.
8. Patients who are scheduled to undergo cataract surgery are excluded from the study until after the surgery has been completed.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Open-label treatment with Prazosin

Experimental group

Description:

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.

Treatment:

Drug: Prazosin

Sponsor of this trial

Lead Sponsor

University of Manitoba