1. Introduction The treatment of traumatized refugees is one of the least researched areas within the field of psychiatry. This is a problem for both patients and mental health workers, who wants to offer evidence based treatment to this group of patients. More than 100.000 refugees are living in Denmark alone. Studies estimates that more than 30% of refugees suffer from Post Traumatic Stress Disorder (PTSD) making this patient group considerable in size as well as a socio-economic challenge(1). Sufficient evidence is lacking on the efficiency of medical and psychological treatments of traumatized refugees with PTSD(2). Furthermore the relationship between psychosocial resources and treatment outcome is yet to be investigated(3). The pharmacological treatments of choice is Selective Serotonin Reuptake Inhibitors (SSRI), but evidence is scarce for its effect on complex PTSD in traumatized refugees(4). Dual-action antidepressants could be a promising alternative(5)(6) but so far it has only been studied in one very small randomised trial (7) Method This study will include approximately 150 patients, randomized into two groups treated with either Sertraline or Venlafaxine. Patients in both groups will receive the same manual-based Cognitive Behavioural Therapy adapted to this group of patients. The study period is 6-7 months. Treatment course and data collection is shown in the figure below and consist of: 10 consultations with a medical doctor 16 consultations with a psychologist At least 2 individual sessions with social counselors and option to participate in group lectures. The treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy Charlotte Sonne 1,2, Jessica Carlsson 1, Morten Ekstrøm 1, Ask Elklit 2,, Per Bech 3 and Erik Lykke Mortensen 3 1 Competence Center for Transcultural Psychiatry (CTP), Psychiatric Center Ballerup, Mental Health Services - Capital Region of Denmark. 2 University of Southern Denmark 3 University of Copenhagen Social counselors are conducting group lectures on the Danish social service system and other topics relevant to the patients REFERENCES: 1.Steel Z, Chey T, Silove D, Marnane C, Bryant RA, van Ommeren M: Association of torture and other potentially traumatic events with mental health outcomes among populations exposed to mass conflict and displacement: a systematic review and meta-analysis. JAMA 2009;302(5):537-49. 2.Hetrick S, Purcell R, Garner B, Parslow R: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder ( PTSD ). The Cochrane Library 2010. 3.Region Syddanmarks Center for Kvalitet: MTV om behandling og rehabilitering af PTSD – herunder traumatiserede flygtninge. 2008. http://doc.rct.dk/ 4.Stein DJ, Ipser J, Seedat S: Pharmacotherapy for post traumatic stress disorder ( PTSD ). The Cochrane Library 2009. 5.Davidson J, Rothbaum BO, Tucker P, Asnis G, Benattia I, Musgnung JJ: Venlafaxine extended release in posttraumatic stress disorder: a sertraline- and placebo- controlled study. J Clin Psychopharmacol. 2006 Jun;26(3):259-67 6.Hamner MB, Frueh BC: Response to Venlafaxine in a previously antidepressant treatment-resistant combat veteran with post-traumatic stress disorder. Int Clin Psychopharmacol.1998 Sep;13(5):233–4. 7.Smajkic A, Weine S, Djuric-Bijedic Z, Boskailo E,Lewis J, Pavkovic I: Sertraline, Paroxetine, and Venlafaxine in Refugee Posttraumatic Stress Disorder With Depression symptoms. J Trauma Stress. 2001 Jul;14(3):445-52. Pre-treatment consultation (project information and inclusion) Pre-treatment consultation: 1st self-rating 1st HAM D + A observer rating Pre-treatment consultation: 1st self-rating 1st HAM D + A observer rating Weekly consultations with medical doctor: treatment with Sertraline + psycho- education. Weekly consultations with medical doctor: treatment with Venlafaxine + psycho-education. Weekly psychotherapy sessions with psychologist. Monthly consultations with medical doctor; adjustment of Sertraline dosage and psycho-education. Weekly psychotherapy sessions with psychologist. Monthly consultations with medical doctor; adjustment of Sertraline dosage and psycho-education. Weekly psychotherapy sessions with psychologist. Monthly consultations with medical doctor; adjustment of Venlafaxine dosage and psycho-education. Weekly psychotherapy sessions with psychologist. Monthly consultations with medical doctor; adjustment of Venlafaxine dosage and psycho-education. After 6-7 months’ treatment programme: Evaluation and termination of treatment programme Week 1-6 of treatment Week 6-24 of treatment After 6 weeks of treatment: 2nd self-rating After 6 weeks of treatment: 2nd self-rating After completion of treatment: 3rd self-rating 2nd HAM D + A observer rating After completion of treatment: 3rd self-rating 2nd HAM D + A observer rating  Evidence of the efficacy of medical and psychological treatments of traumatized refugees with PTSD is very scarce.  In the present study two types of antidepressants and 15 possible outcome predictors are investigated. The aim is to generate new knowledge on treatment and clinical evaluation of traumatized refugees which can be used in reference programmes and clinical guidelines.  Results are expected to be published ultimo 2014.  Evidence of the efficacy of medical and psychological treatments of traumatized refugees with PTSD is very scarce.  In the present study two types of antidepressants and 15 possible outcome predictors are investigated. The aim is to generate new knowledge on treatment and clinical evaluation of traumatized refugees which can be used in reference programmes and clinical guidelines.  Results are expected to be published ultimo 2014. Take home messages Follow our projects on: www.ctp-net.dk by scanning this code: QR Study supported by: Helsefonden  To examine differences in the treatment outcome of patients treated with Venlafaxine and Sertraline respectively.  To study the relation between changes in symptoms on PTSD /depression and changes in social functioning from baseline to post-treatment evaluation.  To investigate if pre-treatment ratings of patients’ psycho-social resources correlate with the treatment outcome of the individual patient.  To examine differences in the treatment outcome of patients treated with Venlafaxine and Sertraline respectively.  To study the relation between changes in symptoms on PTSD /depression and changes in social functioning from baseline to post-treatment evaluation.  To investigate if pre-treatment ratings of patients’ psycho-social resources correlate with the treatment outcome of the individual patient. Objectives Outcome measures Trial endpoints will be PTSD, depressive and anxiety symptoms as well as social functioning measured by validated ratings scales – see figure 1. Furthermore,15 different psycho-social factors that might be associated with treatment outcome, are rated on a 0-4 Likert scale during the first session with the patient. At the end of the treatment course, the individual predictors as well as the total score from the Likert scale is compared with changes on the primary outcome measures. Figure 1: Primary and secondary outcome measures Primary outcome measure  Harvard Trauma Questionnaire (HTQ) part IV: Self-rating consisting of 16 items. Used to monitor the severity of PTSD symptoms Secondary outcome measures  Hopkins Symptom Check List-25 (HSCL-25): Self-raring consisting of 25 items. Used to monitor the severity of anxiety and depressive symptoms.  Social Adjustment Scale Self Report (SAS-SR) short version: Self-raring consisting of 24 items. Used to monitor changes in social functioning.  Hamilton Depression and Anxiety Ratings Scales (HAM D+A ): Semi-structured interviews used to monitor depressive and anxiety symptoms. In this study the interviews are carried out by a trained team of medical students who are blinded towards the intervention groups AUTHOR FOR CORRESPONDANCE: Charlotte Sonne, MD, PhD-student Competence Center for Transcultural Psychiatry Gentofte Hospital Niels Andersensvej 65 Tel. +45 3864 6173 E-mail: charlotte.sonne@regionh.dkcharlotte.sonne@regionh.dk