Posttraumatic Stress Disorder
Conditions
Interventions
Participants will be randomized into an Intervention and Control group.
From the statistical analysis performed, a sample size of 52 patients was reached, equally allocated to the Intervention (n = 2
Drug
E02.319
Sponsors
Universidade Federal de Santa Maria
Universidade Federal de Santa Maria
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Check for improvement of each symptom associated with PTSD, through the score on each item of the PCL-5; symptoms are scored from 0 to 4, according to severity ;Check for improvement of symptoms associated with PTSD, globally, by the total score in CAPS-5;symptoms are scored from 0 to 4, according to severity ;Check for improvement of the clinical perception about the severity of the disorder, through the CGI scale; according to the grade (from 0 to 7) of each of the two answers ;Check for improvement of the quality of patients' sleep, through PSQI-BR; scale composed of 19 questions, rated from 0 to 3, the higher the score the worse the sleep quality;Check for improvement of the daytime sleepiness presented by the patients, through the ESSE-BR score; the instrument consists of 8 questions with scores ranging from 0 to 3, the higher the final score, the greater the daytime sleepiness ;Check for improvement of patients' self-perception of their quality of life, through WHOQOL-Bref; the instrument presents 26 questions and assesses the patient's perception of their quality of life, under the following aspects: physical; psychological; social relations and the environment.;Check the improvement in the severity of the symptoms of anxiety and depression using the scores on the HAMA and HAM-D scales; HAMA evaluates psychic and somatic anxiety symptoms, assigning a score of 0 to 3 for the severity of these symptoms, the higher the final score, the more severe the anxiety. HAM-D assesses depressive symptoms of mood, cognitive, somatic, motor and anxiety, a score ranging from 0 to 2, up to 0 to 4 is assigned - depending on the symptom. The higher the final score, the more severe the depression. | — |
Countries
Brazil
Contacts
Public ContactPedro;Pedro Canova Mosele;Canova Mosele
Universidade Federal de Santa Maria;Universidade Federal de Santa Maria
Outcome results
None listed