Clinical trial NCT03894345: 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
Overall status: SUSPENDED
Phase: PHASE1
Conditions: Anxiety
Anxiety Disorders
Lead sponsor: University of Manitoba
Sponsor class: OTHER
First posted: 2019-03-28
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Change in Anxiety Symptoms
timeFrame: To be completed at baseline and weekly during weeks 2,3,4,5,6,7, 8 to assess changes over the last week
measure: Change in Anxiety Symptoms
timeFrame: 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:
measure: Change in Depressive Symptoms
timeFrame: To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks
measure: Change in Level of Disability
timeFrame: To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks
measure: Change in Overall Symptom Severity
timeFrame: Previous 2 weeks
measure: Changes in Experienced Symptoms
timeFrame: Completed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to assess changes over the past week
measure: Tolerability of Medication (Heart Rate)
timeFrame: To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to monitor changes since last visit
measure: Tolerability of Medication (blood pressure)
timeFrame: To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
measure: Side Effects
timeFrame: To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
measure: Change in Sleep Impairment
timeFrame: Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks
Other outcomes:
Locations:
city: Winnipeg
country: Canada
facility: University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic
state: Manitoba
Study officials:
affiliation: University of Manitoba
name: Jitender Sareen, MD
role: PRINCIPAL_INVESTIGATOR
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