DOXAZOSIN FOR PTSD

Sponsor

Baylor College of Medicine (Other)

Overall Status

Completed

CT.gov ID

NCT02308202

Collaborator

(none)

Enrollment

Location

Arms

29.9

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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

Study Design

Study Type:

Interventional

Actual 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

Actual Study Start Date :

Jan 1, 2012

Actual Primary Completion Date :

Jun 30, 2014

Actual Study Completion Date :

Jun 30, 2014

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 55 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Be aged between 18 and 55 years
Meet DSM-IV TR criteria for PTSD
Meet inclusion criteria for VRE participation
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)
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
Have a baseline ECG that demonstrates clinically normal sinus rhythm, clinically normal conduction, and no clinically significant arrhythmias
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:

Have any history or evidence suggestive of seizure disorder or brain injury
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
Have evidence of untreated or unstable medical illness including neuroendocrine, autoimmune, renal, hepatic, or active infectious disease
Have HIV and are currently symptomatic or are taking antiretroviral medication
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
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