Prazosin Use in Adults With Anxiety Disorders

October 31, 2022 updated by: University of Manitoba

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

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.

Study Overview

Status

Suspended

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Manitoba
      • Winnipeg, Manitoba, Canada, R3E 3N4
        • University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.

Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy
Other Names:
  • Minipress

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Anxiety Symptoms
Time Frame: To be completed at baseline and weekly during weeks 2,3,4,5,6,7, 8 to assess changes over the last week
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
Time Frame: 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.
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
Time Frame: 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.
To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks
Change in Level of Disability
Time Frame: 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)
To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks
Change in Overall Symptom Severity
Time Frame: 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).
Previous 2 weeks
Changes in Experienced Symptoms
Time Frame: 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)
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)
Time Frame: 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
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)
Time Frame: 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
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
Side Effects
Time Frame: 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.
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
Change in Sleep Impairment
Time Frame: 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).
Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jitender Sareen, MD, University of Manitoba

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 24, 2019

Primary Completion (Anticipated)

December 1, 2023

Study Completion (Anticipated)

December 1, 2023

Study Registration Dates

First Submitted

February 14, 2019

First Submitted That Met QC Criteria

March 26, 2019

First Posted (Actual)

March 28, 2019

Study Record Updates

Last Update Posted (Actual)

November 2, 2022

Last Update Submitted That Met QC Criteria

October 31, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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