Prazosin Use in Adults With Anxiety Disorders

Phase 1

Suspended

• Conditions: Anxiety; Anxiety Disorders
• Interventions: Drug: Prazosin

• Registration Number: NCT03894345
• Lead Sponsor: University of Manitoba

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-14
• Study First Submitted QC: 2019-03-26
• Study First Posted: 2019-03-28
• Study Start: 2019-05-24
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-31
• Last Update Posted: 2022-11-02
• Primary Completion: 2023-12
• Study Completion: 2023-12

Recruitment & Eligibility

• Status: SUSPENDED
• Sex: All
• Target Recruitment: 20

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Open-label treatment with Prazosin	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.

Primary Outcome Measures

Name	Time	Method
Change in Anxiety Symptoms	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.

Secondary Outcome Measures

Name	Time	Method
Side Effects	To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8	To examine the overall tolerability and side effects of prazosin by recording potential adverse symptoms using a Vital Signs and Adverse Symptoms Checklist.
Change in Depressive Symptoms	To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks	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.
Change in Overall Symptom Severity	Previous 2 weeks	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).
Changes in Experienced Symptoms	Completed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to assess changes over the past week	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)
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	To examine the overall tolerability of prazosin by recording heart rate at each visit
Tolerability of Medication (blood pressure)	To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8	To examine the overall tolerability of prazosin by recording blood pressure at each visit in the sitting and standing positions
Change in Level of Disability	To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks	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)
Change in Sleep Impairment	Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks	To examine sleep quality following the use of prazosin as measured by the Insomnia Severity Index (ISI).

Trial Locations

Locations (1)

University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic; 🇨🇦 Winnipeg, Manitoba, Canada