Post traumatic stress disorder
Conditions
Interventions
120 women raped in the last six months with a confirmed diagnosis of post traumatic stress disorder will be included. They will be randomized in two groups, one will receive sertraline between 50 and
Drug
Behavioural
Sponsors
Escola Paulista de Medicina
Departamento de psiquiatria da Universidade Federal de São Paulo
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Women; between 18-45 years old; raped in the last six months; evaluated at Perola Byington Hospital specialized service; with post traumatic stress disorder.
Exclusion criteria
Exclusion criteria: Menopause; mental retardation; clinical and neurological diseases not under control; schizophrenia; bipolar disorder; drug or alcohol dependence.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Scores of the Clinical Global Impression (CGI) scale at every visit. The scale points are from 0=no symptoms to 7=extremely worse. Measured at 2, 4, 8 and 14 weeks. It is expected that patients could improve in both treatment arms, with a score reduction of at least 2 points.;Improvement of PTSD symptoms measured by the CAPS scale. The scale has 30 itens that adresses 20 PTSD symptoms. Itens are scored as 0=no symptom to 4=severe symptom. A 50% reduction of symptomatology is expected. | — |
Secondary
| Measure | Time frame |
|---|---|
| Beck depression (BDI) and Anxiety (BAI)inventories are self report scales that will be applied to evaluate associated symptoms of anxiety and depression. Both scales scores are from 0-63 points. For BDI mild depression is considered up to 10 points and up to 20 severe depression. For BAI up to 8 is mild anxiety and up to 26 is severe anxiety. Symptomatology is expected to decrease with the treatment with a 50% score reduction. | — |
Countries
Brazil
Contacts
Public ContactMarcelo de Mello
Universidade Federal de Sao Paulo-Depto de Psiquiatria
Outcome results
None listed