title: Treatment of traumatized refugees with sertraline versus venlafaxine in combination with psychotherapy - study protocol for a randomized clinical trial.
abstract: BACKGROUND
  Sufficient evidence is lacking to draw final conclusions on the efficiency of medical and psychological treatments of traumatized refugees with PTSD. The pharmacological treatments of choice today for post-traumatic stress disorder are antidepressants from the subgroup selective serotonin reuptake inhibitors, especially sertraline. The evidence for the use of selective serotonin reuptake inhibitors in the treatment of complex post-traumatic stress disorder in traumatized refugees is very limited. Venlafaxine is a dual-action antidepressant that works on several pathways in the brain. It influences areas in the brain which are responsible for the enhanced anxiety and hyper-arousal experienced by traumatized refugees and which some studies have found to be enlarged among patients suffering from post-traumatic stress disorder.
  
  
  METHODS
  This study will include approximately 150 patients, randomized into two different groups treated with either sertraline or venlafaxine. Patients in both groups will receive the same manual-based cognitive behavioral therapy, which has been especially adapted to this group of patients. The treatment period will be 6 to 7 months. The trial endpoints will be post-traumatic stress disorder and depressive symptoms and social functioning, all measured on validated ratings scales. Furthermore the study will examine the relation between a psycho-social resources and treatment outcome based on 15 different possible outcome predictors.
  
  
  CONCLUSIONS
  This study is expected to bring forward new knowledge on treatment and clinical evaluation of traumatized refugees and the results are expected to be used in reference programs and clinical guidelines.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01569685.
authors.affiliation: Psychiatric Trauma Clinic for Refugees, Gentofte Hospital, opg. 32, st. Niels Andersens vej 65, 2900 Hellerup, Denmark. charlotte.sonne@regionh.dk
authors.forename: Charlotte
authors.initials: C
authors.lastname: Sonne
authors.forename: Jessica
authors.initials: J
authors.lastname: Carlsson
authors.forename: Ask
authors.initials: A
authors.lastname: Elklit
authors.forename: Erik Lykke
authors.initials: EL
authors.lastname: Mortensen
authors.forename: Morten
authors.initials: M
authors.lastname: Ekstrøm
mesh_terms: D002985:Clinical Protocols; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003511:Cyclohexanols / Q000009:adverse effects / Q000627:therapeutic use*; D003718:Denmark; D006801:Humans; D011569:Psychiatric Status Rating Scales; D012036:Refugees / Q000523:psychology*; D012107:Research Design; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D020280:Sertraline / Q000009:adverse effects / Q000627:therapeutic use*; D013313:Stress Disorders, Post-Traumatic / Q000175:diagnosis / Q000188:drug therapy / Q000523:psychology / Q000628:therapy*; D013997:Time Factors; D016896:Treatment Outcome; D000069470:Venlafaxine Hydrochloride
chemical_list: D003511:Cyclohexanols; D017367:Selective Serotonin Reuptake Inhibitors; D020280:Sertraline; D000069470:Venlafaxine Hydrochloride