Prazosin Use in Adults With Anxiety Disorders

NCT03894345 | Suspended Phase 1

• 1 other identifier: HS21444 (B2018:002) PRA2051N
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anxiety; Anxiety Disorders

Outcome Measures

Primary Outcomes (2)

• 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.

  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

  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 Outcomes (8)

• Change in Depressive Symptoms

  To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks

• Change in Level of Disability

  To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks

• Change in Overall Symptom Severity

  Previous 2 weeks

• Changes in Experienced Symptoms

  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)

  To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to monitor changes since last visit

Study Arms (1)

Open-label treatment with Prazosin

EXPERIMENTAL

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

Interventions

Prazosin DRUG

Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy

Also known as: Minipress

Open-label treatment with Prazosin

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic

Winnipeg, Manitoba, R3E 3N4, Canada

Location

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MeSH Terms

Conditions

Anxiety Disorders

Interventions

Prazosin

Condition Hierarchy (Ancestors)

Mental Disorders

Intervention Hierarchy (Ancestors)

Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Jitender Sareen, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2019
• First Posted: March 28, 2019
• Study Start: May 24, 2019
• Primary Completion: December 1, 2023
• Study Completion: December 1, 2023
• Last Updated: November 2, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)