Back to resultsPrazosin Use in Adults With Anxiety Disorders
Primary Purpose
Anxiety, Anxiety Disorders
Status
Suspended
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Prazosin
Sponsored by
About this trial
This is an interventional treatment trial for Anxiety
Eligibility Criteria
Inclusion Criteria:
- Existing Diagnosis of any anxiety disorder according to DSM-5 criteria (i.e. GAD, Panic Disorder, Agoraphobia, Social Phobia or Specific phobias)
- Newly diagnosed patients or patients who are either resistant or not adherent to their current treatment are eligible to be enrolled in the study.
- 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:
- Patients with comorbid condition of psychosis, a diagnosis of PTSD, an active severe substance use disorder, or actively suicidal.
- Patients actively enrolled in psychotherapy sessions at the time of the study.
- 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.
- Pregnant or lactating women.
- Patients with acute medical or psychiatric conditions that require immediate hospital admission.
- Patients with a history of allergic reaction to prazosin or any of its components.
- Patients unable to communicate in English.
- Patients who are scheduled to undergo cataract surgery are excluded from the study until after the surgery has been completed.
Sites / Locations
- University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Open-label treatment with Prazosin
Arm Description
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.
Outcomes
Primary Outcome Measures
Change in Anxiety Symptoms
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
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
Change in Depressive Symptoms
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
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
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
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 examine the overall tolerability of prazosin by recording heart rate at each visit
Tolerability of Medication (blood pressure)
To examine the overall tolerability of prazosin by recording blood pressure at each visit in the sitting and standing positions
Side Effects
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
To examine sleep quality following the use of prazosin as measured by the Insomnia Severity Index (ISI).
Full Information
NCT ID
NCT03894345
First Posted
February 14, 2019
Last Updated
October 31, 2022
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT03894345
Brief Title
Prazosin Use in Adults With Anxiety Disorders
Official Title
Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Suspended
Why Stopped
COVID-19
Study Start Date
May 24, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Manitoba
4. Oversight
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
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anxiety, Anxiety Disorders
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Open-label treatment with Prazosin
Arm Type
Experimental
Arm Description
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 Type
Drug
Intervention Name(s)
Prazosin
Other Intervention Name(s)
Minipress
Intervention Description
Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy
Primary Outcome Measure Information:
Title
Change in Anxiety Symptoms
Description
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.
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
Title
Change in Anxiety Symptoms
Description
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.
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
Secondary Outcome Measure Information:
Title
Change in Depressive Symptoms
Description
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.
Time Frame
To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks
Title
Change in Level of Disability
Description
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)
Time Frame
To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks
Title
Change in Overall Symptom Severity
Description
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).
Time Frame
Previous 2 weeks
Title
Changes in Experienced Symptoms
Description
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)
Time Frame
Completed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to assess changes over the past week
Title
Tolerability of Medication (Heart Rate)
Description
To examine the overall tolerability of prazosin by recording heart rate at each visit
Time Frame
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to monitor changes since last visit
Title
Tolerability of Medication (blood pressure)
Description
To examine the overall tolerability of prazosin by recording blood pressure at each visit in the sitting and standing positions
Time Frame
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
Title
Side Effects
Description
To examine the overall tolerability and side effects of prazosin by recording potential adverse symptoms using a Vital Signs and Adverse Symptoms Checklist.
Time Frame
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
Title
Change in Sleep Impairment
Description
To examine sleep quality following the use of prazosin as measured by the Insomnia Severity Index (ISI).
Time Frame
Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Existing Diagnosis of any anxiety disorder according to DSM-5 criteria (i.e. GAD, Panic Disorder, Agoraphobia, Social Phobia or Specific phobias)
Newly diagnosed patients or patients who are either resistant or not adherent to their current treatment are eligible to be enrolled in the study.
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:
Patients with comorbid condition of psychosis, a diagnosis of PTSD, an active severe substance use disorder, or actively suicidal.
Patients actively enrolled in psychotherapy sessions at the time of the study.
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.
Pregnant or lactating women.
Patients with acute medical or psychiatric conditions that require immediate hospital admission.
Patients with a history of allergic reaction to prazosin or any of its components.
Patients unable to communicate in English.
Patients who are scheduled to undergo cataract surgery are excluded from the study until after the surgery has been completed.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jitender Sareen, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3E 3N4
Country
Canada
12. IPD Sharing Statement
Plan to Share IPD
No
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Prazosin Use in Adults With Anxiety Disorders
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