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DOXAZOSIN FOR PTSD

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ClinicalTrials.gov Identifier: NCT02308202
Recruitment Status : Unknown
Verified July 2017 by Thomas Newton, Baylor College of Medicine.
Recruitment status was:  Recruiting
First Posted : December 4, 2014
Last Update Posted : July 12, 2017
Sponsor:
Information provided by (Responsible Party):
Thomas Newton, Baylor College of Medicine

Brief Summary:

The aims of this study is to determine the effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR) exposure therapy on Post Traumatic Stress Disorder.

The effects of treatment with doxazosin XL 16 mg/d combined with virtual reality (VR) exposure therapy will be assessed in double-blind, placebo-controlled study. The study will enroll 30 participants. The investigators will use a within groups design in which all participants receive both placebo and doxazosin (N=16) with the order counterbalanced across participants. A second group of patients (N=16) will receive both 16mg perindopril and placebo instead of doxazosin/placebo.


Condition or disease Intervention/treatment Phase
PTSD Drug: doxazosin Drug: Perindopril Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: DOXAZOSIN AS A TREATMENT FOR POST TRAUMATIC STRESS SYNDROME
Study Start Date : January 2012
Estimated Primary Completion Date : December 31, 2018
Estimated Study Completion Date : December 31, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: doxazosin
Subjects will be randomized to receive either doxazosin XL or placebo. Participants will receive doses of study medication as over-encapsulated doxazosin XL or placebo dosed once in the morning. Study medication will be initiated as one capsule of doxazosin XL 4 mg or placebo given in the morning. The dose will be titrated up to 16 mg/d doxazosin XL or placebo as follows: Days 1-4: 4mg, Days 5-8: 8mg, Day 9-12: 12 mg, Days 13-16: 16 mg.
Drug: doxazosin
Active Comparator: perindopril
Subjects will be randomized to receive either perindopril 16mg or placebo for 8 days. Participants will receive doses of study medication as over-encapsulated perindopril or placebo dosed once in the morning.
Drug: Perindopril
Placebo Comparator: placebo
Subjects will be randomized to receive either doxazosin XL or placebo. Participants will receive placebo for doxazosin XL for 16 days and placebo for perindopril for 8 days.
Drug: Placebo



Primary Outcome Measures :
  1. The primary outcome measures are the Subjective Units of Distress Scale (SUDS) and PTSD Checklist (PCL) (m) ratings during VRE Iraq exposure. [ Time Frame: 0 and 16 days ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Be male OIF/OEF veteran or active duty. Males only are included in this small pilot study because we will not have sufficient sample size to analyze gender effects. Women will be included in subsequent studies
  2. Be aged between 18 and 55 years
  3. Meet DSM-IV TR criteria for PTSD
  4. Meet inclusion criteria for VRE participation
  5. Have vital signs as follows: supine blood pressure > 100/65 mm Hg, a seated blood pressure greater than 90/60 mm Hg, and an orthostatic change smaller than20 mm Hg systolic or 10 mm Hg diastolic on standing. Participants should not have hypertension (BP above 150/100)
  6. Have hematology and chemistry laboratory tests that are within reference limits (±10%), with the following exceptions: (a) total bilirubin must be less than 2x upper limit of normal and ALT, AST, and alkaline phosphatase less than 3× the upper limit of normal and (b) kidney function tests (creatinine and BUN) within normal limits
  7. Have a baseline ECG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
  8. Have a medical history and brief physical examination demonstrating no clinically significant contraindications for study participation, in the judgment of the admitting physician and the principal investigator

Exclusion Criteria:

  1. Have any history or evidence suggestive of seizure disorder or brain injury
  2. Have neurological or psychiatric disorders, such as psychosis or bipolar illness as assessed by Structural Clinical Interview for DSM disorders (SCID); clinically significant organic brain disease or dementia or Axis I psychiatric illness other than PTSD that would interfere with study; acceptable history of suicide attempts within the past year and/or current suicidal ideation/plan
  3. Have evidence of untreated or unstable medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
  4. Have HIV and are currently symptomatic or are taking antiretroviral medication
  5. Have any other illness or condition which in the opinion of the PI and/or the admitting physician would preclude safe and/or successful completion of the study
  6. Dr. Newton (medical supervisor) will review potential participants' prescribed medication to make a final decision on eligibility. We anticipate that participants will be on a wide range of medications prescribed for PTSD. However, these treatments will unlikely interact with the doxazosin effects of this study. We will not ask participants to change their medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02308202


Contacts
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Contact: Daisy Thompson-Lake 713 791-1414 x. 26818 dgthomps@bcm.edu

Locations
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United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
Baylor College of Medicine
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Thomas Newton, Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT02308202    
Other Study ID Numbers: H-29283
First Posted: December 4, 2014    Key Record Dates
Last Update Posted: July 12, 2017
Last Verified: July 2017
Keywords provided by Thomas Newton, Baylor College of Medicine:
PTSD
treatment
virtual reality
doxazosin
Additional relevant MeSH terms:
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Perindopril
Doxazosin
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antihypertensive Agents
Adrenergic alpha-1 Receptor Antagonists
Adrenergic alpha-Antagonists
Adrenergic Antagonists
Adrenergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs