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Prazosin Use in Adults With Anxiety Disorders

Sponsor
University of Manitoba (Other)
Overall Status
Suspended
CT.gov ID
NCT03894345
Collaborator
(none)
20
Enrollment
1
Location
1
Arm
54.3
Anticipated Duration (Months)
0.4
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
Actual Study Start Date :
May 24, 2019
Anticipated Primary Completion Date :
Dec 1, 2023
Anticipated Study Completion Date :
Dec 1, 2023

Arms and Interventions

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.

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. 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]

      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.

    2. 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

    1. 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.

    2. 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)

    3. 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).

    4. 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)

    5. 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

    6. 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

    7. 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.

    8. 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).

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 60 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic Winnipeg Manitoba Canada R3E 3N4

    Sponsors and Collaborators

    • University of Manitoba

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    University of Manitoba
    ClinicalTrials.gov Identifier:
    NCT03894345
    Other Study ID Numbers:
    • HS21444 (B2018:002) PRA2051N
    First Posted:
    Mar 28, 2019
    Last Update Posted:
    Sep 22, 2021
    Last Verified:
    Sep 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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
    Additional relevant MeSH terms:
    Anxiety Disorders
    Prazosin

    Study Results

    No Results Posted as of Sep 22, 2021