- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03894345
Prazosin Use in Adults With Anxiety Disorders
October 31, 2022 updated by: University of Manitoba
Open Label 8-Week Study of Prazosin Use in Adults With Anxiety Disorders
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
20
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Manitoba
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Winnipeg, Manitoba, Canada, R3E 3N4
- University of Manitoba - PsycHealth - Mood and Anxiety Disorders Clinic
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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. |
Competitive alpha-1 adrenergic receptor blocker which has been used to treat PTSD and Benign Prostatic Hypertrophy
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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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
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.
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
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To be completed at baseline,weeks 2, 4 and 8 to assess changes since last previous 2 weeks
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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
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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)
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To be completed at baseline, weeks 2, 4 and 8 to assess changes over the previous 2 weeks
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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).
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Previous 2 weeks
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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
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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)
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Completed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to assess changes over the past week
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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
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To examine the overall tolerability of prazosin by recording heart rate at each visit
|
To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8 to monitor changes since last visit
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Tolerability of Medication (blood pressure)
Time Frame: To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
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To examine the overall tolerability of prazosin by recording blood pressure at each visit in the sitting and standing positions
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To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
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Side Effects
Time Frame: To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
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To examine the overall tolerability and side effects of prazosin by recording potential adverse symptoms using a Vital Signs and Adverse Symptoms Checklist.
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To be assessed at Baseline, and at weeks 2, 3, 4, 5, 6, 7, 8
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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
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To examine sleep quality following the use of prazosin as measured by the Insomnia Severity Index (ISI).
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Will be completed by patients at baseline, weeks 2,4 and 8 to assess changes over the previous 2 weeks
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jitender Sareen, MD, University of Manitoba
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Wittchen HU, Carter RM, Pfister H, Montgomery SA, Kessler RC. Disabilities and quality of life in pure and comorbid generalized anxiety disorder and major depression in a national survey. Int Clin Psychopharmacol. 2000 Nov;15(6):319-28. doi: 10.1097/00004850-200015060-00002.
- Morin CM, Belleville G, Belanger L, Ivers H. The Insomnia Severity Index: psychometric indicators to detect insomnia cases and evaluate treatment response. Sleep. 2011 May 1;34(5):601-8. doi: 10.1093/sleep/34.5.601.
- Zaider TI, Heimberg RG, Fresco DM, Schneier FR, Liebowitz MR. Evaluation of the clinical global impression scale among individuals with social anxiety disorder. Psychol Med. 2003 May;33(4):611-22. doi: 10.1017/s0033291703007414.
- Raskind MA, Peskind ER, Kanter ED, Petrie EC, Radant A, Thompson CE, Dobie DJ, Hoff D, Rein RJ, Straits-Troster K, Thomas RG, McFall MM. Reduction of nightmares and other PTSD symptoms in combat veterans by prazosin: a placebo-controlled study. Am J Psychiatry. 2003 Feb;160(2):371-3. doi: 10.1176/appi.ajp.160.2.371.
- Taylor FB, Martin P, Thompson C, Williams J, Mellman TA, Gross C, Peskind ER, Raskind MA. Prazosin effects on objective sleep measures and clinical symptoms in civilian trauma posttraumatic stress disorder: a placebo-controlled study. Biol Psychiatry. 2008 Mar 15;63(6):629-32. doi: 10.1016/j.biopsych.2007.07.001. Epub 2007 Sep 14.
- Kessler RC, Nelson CB, McGonagle KA, Edlund MJ, Frank RG, Leaf PJ. The epidemiology of co-occurring addictive and mental disorders: implications for prevention and service utilization. Am J Orthopsychiatry. 1996 Jan;66(1):17-31. doi: 10.1037/h0080151.
- Bland RC, Newman SC, Orn H. Period prevalence of psychiatric disorders in Edmonton. Acta Psychiatr Scand Suppl. 1988;338:33-42. doi: 10.1111/j.1600-0447.1988.tb08545.x.
- Dick CL, Bland RC, Newman SC. Epidemiology of psychiatric disorders in Edmonton. Panic disorder. Acta Psychiatr Scand Suppl. 1994;376:45-53.
- Baldwin DS, Waldman S, Allgulander C. Evidence-based pharmacological treatment of generalized anxiety disorder. Int J Neuropsychopharmacol. 2011 Jun;14(5):697-710. doi: 10.1017/S1461145710001434. Epub 2011 Jan 7.
- Opbroek A, Delgado PL, Laukes C, McGahuey C, Katsanis J, Moreno FA, Manber R. Emotional blunting associated with SSRI-induced sexual dysfunction. Do SSRIs inhibit emotional responses? Int J Neuropsychopharmacol. 2002 Jun;5(2):147-51. doi: 10.1017/S1461145702002870.
- Birnbaum S, Gobeske KT, Auerbach J, Taylor JR, Arnsten AF. A role for norepinephrine in stress-induced cognitive deficits: alpha-1-adrenoceptor mediation in the prefrontal cortex. Biol Psychiatry. 1999 Nov 1;46(9):1266-74. doi: 10.1016/s0006-3223(99)00138-9.
- Hieble JP, Ruffolo RR Jr. The use of alpha-adrenoceptor antagonists in the pharmacological management of benign prostatic hypertrophy: an overview. Pharmacol Res. 1996 Mar;33(3):145-60. doi: 10.1006/phrs.1996.0022.
- Skelly MJ, Weiner JL. Chronic treatment with prazosin or duloxetine lessens concurrent anxiety-like behavior and alcohol intake: evidence of disrupted noradrenergic signaling in anxiety-related alcohol use. Brain Behav. 2014 Jul;4(4):468-83. doi: 10.1002/brb3.230. Epub 2014 Apr 14.
- Pickworth WB, Sharpe LG, Nozaki M, Martin WR. Sleep suppression induced by intravenous and intraventricular infusions of methoxamine in the dog. Exp Neurol. 1977 Dec;57(3):999-1011. doi: 10.1016/0014-4886(77)90123-6. No abstract available.
- Boynton L, Bentley J, Strachan E, Barbato A, Raskind M. Preliminary findings concerning the use of prazosin for the treatment of posttraumatic nightmares in a refugee population. J Psychiatr Pract. 2009 Nov;15(6):454-9. doi: 10.1097/01.pra.0000364287.63210.92.
- Raskind MA, Peterson K, Williams T, Hoff DJ, Hart K, Holmes H, Homas D, Hill J, Daniels C, Calohan J, Millard SP, Rohde K, O'Connell J, Pritzl D, Feiszli K, Petrie EC, Gross C, Mayer CL, Freed MC, Engel C, Peskind ER. A trial of prazosin for combat trauma PTSD with nightmares in active-duty soldiers returned from Iraq and Afghanistan. Am J Psychiatry. 2013 Sep;170(9):1003-10. doi: 10.1176/appi.ajp.2013.12081133.
- George KC, Kebejian L, Ruth LJ, Miller CW, Himelhoch S. Meta-analysis of the efficacy and safety of prazosin versus placebo for the treatment of nightmares and sleep disturbances in adults with posttraumatic stress disorder. J Trauma Dissociation. 2016 Jul-Sep;17(4):494-510. doi: 10.1080/15299732.2016.1141150. Epub 2016 Feb 2.
- Simpson TL, Malte CA, Dietel B, Tell D, Pocock I, Lyons R, Varon D, Raskind M, Saxon AJ. A pilot trial of prazosin, an alpha-1 adrenergic antagonist, for comorbid alcohol dependence and posttraumatic stress disorder. Alcohol Clin Exp Res. 2015 May;39(5):808-17. doi: 10.1111/acer.12703. Epub 2015 Apr 1.
- Rodgman C, Verrico CD, Holst M, Thompson-Lake D, Haile CN, De La Garza R 2nd, Raskind MA, Newton TF. Doxazosin XL reduces symptoms of posttraumatic stress disorder in veterans with PTSD: a pilot clinical trial. J Clin Psychiatry. 2016 May;77(5):e561-5. doi: 10.4088/JCP.14m09681.
- Issa SA, Hadid OH, Baylis O, Dayan M. Alpha antagonists and intraoperative floppy iris syndrome: A spectrum. Clin Ophthalmol. 2008 Dec;2(4):735-41. doi: 10.2147/opth.s2697.
- Ruiz MA, Zamorano E, Garcia-Campayo J, Pardo A, Freire O, Rejas J. Validity of the GAD-7 scale as an outcome measure of disability in patients with generalized anxiety disorders in primary care. J Affect Disord. 2011 Feb;128(3):277-86. doi: 10.1016/j.jad.2010.07.010. Epub 2010 Aug 9.
- Carlozzi NE, Kratz AL, Downing NR, Goodnight S, Miner JA, Migliore N, Paulsen JS. Validity of the 12-item World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) in individuals with Huntington disease (HD). Qual Life Res. 2015 Aug;24(8):1963-71. doi: 10.1007/s11136-015-0930-x. Epub 2015 Jan 31.
- Clarke DE, Kuhl EA. DSM-5 cross-cutting symptom measures: a step towards the future of psychiatric care? World Psychiatry. 2014 Oct;13(3):314-6. doi: 10.1002/wps.20154. No abstract available.
- Zuithoff NP, Vergouwe Y, King M, Nazareth I, van Wezep MJ, Moons KG, Geerlings MI. The Patient Health Questionnaire-9 for detection of major depressive disorder in primary care: consequences of current thresholds in a crosssectional study. BMC Fam Pract. 2010 Dec 13;11:98. doi: 10.1186/1471-2296-11-98.
- Maier W, Buller R, Philipp M, Heuser I. The Hamilton Anxiety Scale: reliability, validity and sensitivity to change in anxiety and depressive disorders. J Affect Disord. 1988 Jan-Feb;14(1):61-8. doi: 10.1016/0165-0327(88)90072-9.
- Raskind MA, Peskind ER, Chow B, Harris C, Davis-Karim A, Holmes HA, Hart KL, McFall M, Mellman TA, Reist C, Romesser J, Rosenheck R, Shih MC, Stein MB, Swift R, Gleason T, Lu Y, Huang GD. Trial of Prazosin for Post-Traumatic Stress Disorder in Military Veterans. N Engl J Med. 2018 Feb 8;378(6):507-517. doi: 10.1056/NEJMoa1507598.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 24, 2019
Primary Completion (Anticipated)
December 1, 2023
Study Completion (Anticipated)
December 1, 2023
Study Registration Dates
First Submitted
February 14, 2019
First Submitted That Met QC Criteria
March 26, 2019
First Posted (Actual)
March 28, 2019
Study Record Updates
Last Update Posted (Actual)
November 2, 2022
Last Update Submitted That Met QC Criteria
October 31, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HS21444 (B2018:002) PRA2051N
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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