Posttraumatic Stress Disorder MedDRA version: 9.1 Level: LLT Classification code 10036316 Term: Post-traumatic stress disorder
Conditions
Interventions
Pharmaceutical Form: Coated tablet
INN or Proposed INN: SERTRALINE
CAS Number: 79617962
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration number: 200-
Pharmaceutical Form: C
Sponsors
Psykiatrisk Center Gentofte
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Adults refugees of both genders who have a history of war-related trauma, and symptoms of Post traumatic stress disorder. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Patients with a psychosis or mania according to ICD-diagnostic criteria, who has a substance abuse or who requires hospitalization for the mental health symptoms.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the treatment effect of pharmacotherapy with Mianserine and Sertraline and trauma-focused cognitive behavioural therapy in traumatised refugees;Secondary Objective: To identify risk factors associated with the treatment outcome and to evaluate the acceptability of the treatment for the patients;Primary end point(s): Harvard Trauma Questionnaire | — |
Countries
Denmark
Outcome results
None listed