Does Doxazosin treatment reduce the nightmares of Post Traumatic Stress Disorder?

Phase 3

Recruiting

• Conditions: Posttraumatic Stress Disorder; F43.1

• Registration Number: RBR-688jqz
• Lead Sponsor: niversidade Federal de Santa Maria

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Age between 18 and 60 years (adults); Clinical diagnosis of PTSD by DSM 5 criteria; Using the first-line drug for the treatment of PTSD; Score equal to or greater than 2 (moderately”), in item B2 (Recurrent distressing dreams) of the Brazilian version of the CAPS-5 scale (PTSD scale administered by the clinician).

Exclusion Criteria

Current or past diagnosis of Manic Episode, Hypomanic Episode or Psychotic Disorder (Schizophrenia, Schizoaffective, etc.); Current homicide risk (according to clinical evaluation); Current moderate to severe suicide risk (as assessed by the MINI instrument); Dependence Diagnosis \ Alcohol or Substance Abuse (except caffeine or nicotine) in the last 12 months using the MINI instrument; Diagnosis of acute or chronic clinical disease with risk of instability throughout the study (unstable angina, acute myocardial infarction in the last 6 months, congestive heart failure, chronic renal failure, liver failure, with Hepatitis B or Hepatitis C) .; Clinical diagnosis of severe neurological disease or dementia; Clinical diagnosis of Benign Paroxysmal Postural Vertigo and its differential diagnoses .; Clinical diagnosis of HIV \ AIDS symptomatic or in use of antiretroviral therapy; Pregnancy, lactation or refusal to initiate \ maintain effective contraceptive method .; Systolic Blood Pressure <110 or Postural Hypotension; Initial electrocardiogram indicating clinically significant change in heart rate. ; Transaminases above twice the upper limit of normal; Current use of alpha-1 blockers (Terazosin, Prazosin) or history of inadequate outcome in treatment with this class of drugs for nightmares associated with PTSD; History of severe adverse reaction associated with the use of alpha-1 blockers (major allergic reaction, priapism, angioedema, ophthalmic disorder); Current use of alpha-2 agonists (clonidine, methyldopa, thiazine, guanfacine); Current use of conivaptan, boceprevir, idelalisib, oral antifungals, alfuzosin, pazopanib, silodosin, or tamulosin; Current use of benzodiazepines; Psychotherapy started in the two months prior to the beginning of the study; Refusal not to use Sildenafil, Tadalafil or Vardenafil during the study

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction of nightmares associated with Posttraumatic Stress Disorder, assessed through the score in the item Disturbing and repetitive dreams about the stressful experience” of the PCL-5 scale.