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Alpha-1 Adrenergic Receptor Antagonist

Doxazosin Mesylate, Extended Release for Post-Traumatic Stress Disorder

Phase 2
Recruiting
Led By Anne Richards, MD, MPH
Research Sponsored by San Francisco Veterans Affairs Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
Awards & highlights

Study Summary

This trial will assess doxazosin's effectiveness for treating nightmares, sleep quality, and other PTSD symptoms in adult male and female veterans with PTSD.

Eligible Conditions
  • Post-Traumatic Stress Disorder (PTSD)

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation.
This trial's timeline: 3 weeks for screening, Varies for treatment, and all subjects will wear the actigraph daily for 7 days at pre-treatment baseline (week 0), 7 days in week 5 of study drug treatment, and at end-of-treatment week 8 prior to drug discontinuation. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in CAPS PTS Symptom Score
Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score
Change in Pittsburgh Sleep Quality Index (PSQI)
Secondary outcome measures
Change in minutes of wake after sleep onset (WASO)
Change in sleep maintenance (SM)
Change in total sleep time (TST)
+5 more
Other outcome measures
Beck Depression Inventory (BDI)
Female Sexual Functioning Index (FSFI)
Male Sexual Health Questionnaire (MSHQ)
+2 more

Side effects data

From 2013 Phase 4 trial • 395 Patients • NCT01661621
10%
Dizziness
3%
General weakness
3%
Palpitation
100%
80%
60%
40%
20%
0%
Study treatment Arm
Group 1
Group 2

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Doxazosin Mesylate, Extended ReleaseExperimental Treatment1 Intervention
Subjects will undergo a 4-week titration phase during which doxazosin may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study medication for a 4-week stable dose phase.
Group II: PlaceboPlacebo Group1 Intervention
Subjects will undergo a 4-week titration phase during which the placebo may be increased to a maximum dose of 10mg at bedtime based on symptoms and tolerability. After the 4-week titration phase, subjects will continue at stable dose of study placebo for a 4-week stable dose phase.

Find a Location

Who is running the clinical trial?

United States Department of DefenseFED
861 Previous Clinical Trials
227,114 Total Patients Enrolled
San Francisco Veterans Affairs Medical CenterLead Sponsor
48 Previous Clinical Trials
210,683 Total Patients Enrolled
Northern California Institute of Research and EducationOTHER
27 Previous Clinical Trials
9,884 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently involved in this research endeavor?

"Yes, the current clinical trial is actively recruiting patients as per information on clinicaltrials.gov. This research initiative was posted online on April 15th 2018 and has been updated most recently on October 19th 2022. At present, 80 people are required to be recruited from a single medical site."

Answered by AI

Is recruitment for this trial still ongoing?

"That's accurate. As per the information found on clinicaltrials.gov, recruitment for this medical study is currently ongoing; it was initially posted on April 15th 2018 and updated most recently on October 19th 2022. Eighty volunteers are needed at a single site."

Answered by AI

Have any additional trials been conducted with Doxazosin Mesylate, Extended Release as an active ingredient?

"Presently, there are 7 operational clinical trials analyzing the efficacy of Doxazosin Mesylate, Extended Release with two of these studies in their final stages. Though Oklahoma City is a hub for this medication's research studies, 36 sites across the country are trialling its performance."

Answered by AI

Is there a possibility for me to be included in this medical experiment?

"This therapeutic trial has a capacity of 80 participants that have experienced moral injury and meet the following criteria: U.S. veteran or civilian, aged 18-75 years old, having full PTSD symptoms as indicated by CAPS-5 (Clinician administered PTSD scale) with a score ≥ 20, or scoring ≥12 on CAPS-5 but also registering at least 4 in recurrent distressing dream item on CAPS-IV."

Answered by AI

Has the United States Food and Drug Administration authorized Doxazosin Mesylate, Extended Release?

"Doxazosin Mesylate, Extended Release was rated a 2 for safety on the Power team's scale, which takes into account clinical evidence present in Phase 2 trials that relate to its security but not necessarily efficacy."

Answered by AI

What are the essential goals of this clinical research?

"The primary outcome of this clinical trial will be evaluated over a baseline and end-of-treatment timeline. Specifically, the Change in Clinician Administered PTSD Scale (CAPS) Distressing Dream Score will be observed. Other variables such as Objective measures of change in SM via an advanced actigraph worn like a watch, Total Sleep Time (TST), and Minutes of Wake After Sleep Onset (WASO) data gathered from subjective self-reports will also be assessed to gain further insight into the effects of treatment."

Answered by AI

Is the age limit for participants of this medical study restricted to those under sixty?

"This clinical trial is seeking patients aged between 18 and 75. For those under the age of consent, 68 studies are available while a further 371 can be found for individuals over 65 years old."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD
Anne Richards 2018. "A Randomized Controlled Trial of Doxazosin for Nightmares, Sleep Disturbance, and Non-Nightmare Clinical Symptoms in PTSD". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03339258.
~11 spots leftby Apr 2025
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