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Prazosin Use in Adults With Anxiety Disorders

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ClinicalTrials.gov Identifier: NCT03894345
Recruitment Status : Suspended (COVID-19)
First Posted : March 28, 2019
Last Update Posted : November 2, 2022
Sponsor:
Information provided by (Responsible Party):
University of Manitoba

Tracking Information
First Submitted Date  ICMJE February 14, 2019
First Posted Date  ICMJE March 28, 2019
Last Update Posted Date November 2, 2022
Actual Study Start Date  ICMJE May 24, 2019
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 26, 2019)
  • 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.
  • 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)
  • 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).
  • 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)
  • 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
  • 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
  • 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.
  • 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).
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prazosin Use in Adults With Anxiety Disorders
Official Title  ICMJE Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Anxiety
  • Anxiety Disorders
Intervention  ICMJE Drug: Prazosin
Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy
Other Name: Minipress
Study Arms  ICMJE 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.

Intervention: Drug: Prazosin
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: March 26, 2019)		 20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Estimated Primary Completion Date December 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03894345
Other Study ID Numbers  ICMJE HS21444 (B2018:002) PRA2051N
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party University of Manitoba
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Manitoba
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Jitender Sareen, MD University of Manitoba
PRS Account University of Manitoba
Verification Date October 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP