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History of Changes for Study: NCT03894345
Prazosin Use in Adults With Anxiety Disorders
Latest version (submitted October 31, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 26, 2019 None (earliest Version on record)
2 May 22, 2019 Study Status
3 May 24, 2019 Study Status
4 September 15, 2021 Recruitment Status, Study Status and Contacts/Locations
5 October 31, 2022 Study Status
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Study NCT03894345
Submitted Date:  March 26, 2019 (v1)
Open or close this module Study Identification
Unique Protocol ID: HS21444 (B2018:002) PRA2051N
Brief Title: Prazosin Use in Adults With Anxiety Disorders
Official Title: Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
Secondary IDs:
Open or close this module Study Status
Record Verification: February 2019
Overall Status: Recruiting
Study Start: April 2019
Primary Completion: April 2020 [Anticipated]
Study Completion: April 2020 [Anticipated]
First Submitted: February 14, 2019
First Submitted that
Met QC Criteria:		 March 26, 2019
First Posted: March 28, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:		 March 26, 2019
Last Update Posted: March 28, 2019 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: University of Manitoba
Responsible Party: Sponsor
Collaborators:
Open or close this module Oversight
U.S. FDA-regulated Drug: No
U.S. FDA-regulated Device: No
Data Monitoring:
Open or close this module 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.
Detailed Description:
Open or close this module Conditions
Conditions: Anxiety
Anxiety Disorders
Keywords:
Open or close this module Study Design
Study Type: Interventional
Primary Purpose: Treatment
Study Phase: Phase 1
Interventional Study Model: Single Group Assignment
Number of Arms: 1
Masking: None (Open Label)
Allocation: N/A
Enrollment: 20 [Anticipated]
Open or close this module Arms and Interventions
Arms Assigned Interventions
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
Open or close this module Outcome Measures
Primary Outcome Measures:
1. 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.
2. 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.
Secondary Outcome Measures:
1. 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.
2. 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)
3. 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).
4. 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)
5. 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
6. 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
7. 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.
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).
Open or close this module Eligibility
Minimum Age: 18 Years
Maximum Age: 60 Years
Sex: All
Gender Based:
Accepts Healthy Volunteers: No
Criteria:

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.
Open or close this module Contacts/Locations
Central Contact Person: Jacquelyne Wong, MA
Telephone: 204-787-7729
Email: jwong8@hsc.mb.ca
Central Contact Backup: Jitender Sareen, MD
Telephone: 204-294-7344
Email: Jitender.Sareen@umanitoba.ca
Study Officials: Jacquelyne Wong, MA
Study Director
University of Manitoba
Jitender Sareen, MD
Principal Investigator
University of Manitoba
Locations: Canada, Manitoba
University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic
[Recruiting]
Winnipeg, Manitoba, Canada, R3E 3N4
Contact:Contact: Jacquelyne Wong, MA 204-787-7729 jwong8@hsc.mb.ca
Contact:Sub-Investigator: Jitender Sareen, MD
Contact:Sub-Investigator: Yaseen Al-Allaq, MD
Contact:Sub-Investigator: Jacquelyn Wong, MA
Contact:Sub-Investigator: Renee El-Gabalawy, PhD
Contact:Sub-Investigator: Tanya Sala, MD
Contact:Sub-Investigator: Lynda Kong, MD
Contact:Sub-Investigator: Murray Stein, MD
Contact:Sub-Investigator: Murray Raskind, MD
Contact:Sub-Investigator: Murray Enns, MD
Contact:Sub-Investigator: James Bolton, MD
Open or close this module IPDSharing
Plan to Share IPD: No
Open or close this module References
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