Treatment of traumatized refugees with Sertraline versus Venlafaxine in combination with psychotherapy – study protocol for a randomized clinical trial

Trials

Morten Ekstrøm¹  Erik Lykke Mortensen³  Ask Elklit²  Jessica Carlsson¹  Charlotte Sonne¹ 

[1] Psychiatric Trauma Clinic for Refugees, Gentofte Hospital, opg. 32, st. Niels Andersens vej 65, 2900 Hellerup, Denmark;National Center for Psychotraumatology, Campusvej 55, 5230 Odense, Denmark;Institute of Public Health and Center for Healthy Aging, University of Copenhagen, Øster Farimagsgade 5, 1353 København K, Denmark

关键词: Sertraline;    Venlafaxine;    Trauma;    Depression;    PTSD;    Refugee;   

Others  :  1094043
DOI  :  10.1186/1745-6215-14-137

 received in 2012-10-18, accepted in 2013-04-26,  发布年份 2013

【 摘 要 】

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.

Design

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.

Discussion

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.

Trial registration

ClinicalTrials.gov NCT01569685

【 授权许可】

   
2013 Sonne et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

【 参考文献 】

• [1]Laban CJ, Gernaat HBPE, Komproe IH, Van der Tweel I, De Jong JTVM: Postmigration living problems and common psychiatric disorders in Iraqi asylum seekers in the Netherlands. J Nerv Ment Dis 2005, 193:825-832.
• [2]Lindencrona F, Ekblad S, Hauff E: Mental health of recently resettled refugees from the Middle East in Sweden: the impact of pre-resettlement trauma, resettlement stress and capacity to handle stress. Soc Psychiatry Psychiatr Epidemiol 2008, 43:121-131.
• [3]Stein DJ, Ipser J, Seedat S: Pharmacotherapy for post traumatic stress disorder ( PTSD ) ( Review ). Cochrane Database Syst Rev 2009.
• [4]Hetrick S, Purcell R, Garner B, Parslow R: Combined pharmacotherapy and psychological therapies for post traumatic stress disorder ( PTSD ) ( Review ). Cochrane Database Syst Rev 2010.
• [5]Bisson J, Andrew M: Psychological treatment of post-traumatic stress disorder (PTSD) ( Review). Cochrane Database Syst Rev 2009.
• [6]Region Syddanmarks Center for Kvalitet: MTV om behandling og rehabilitering af PTSD – herunder traumatiserede flygtninge. 2008.
• [7]Hamner MB, Frueh BC: Response to venlafaxine in a previously antidepressant treatment-resistant combat veteran with post-traumatic stress disorder. Int Clin Psychopharmacol 1998, 13:233-234.
• [8]Davidson J, Baldwin D, Stein DJ, Kuper E: Treatment of posttraumatic stress disorder with venlafaxine extended release. Arch Gen Psychiatry 2006, 63:1158-1165.
• [9]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, 26:259-267.
• [10]Hollifield M: Measuring trauma and health status in refugees: a critical review. JAMA 2002, 288:611-621.
• [11]Mollica RF, Wyshak G, De Marneffe D, Khuon F, Lavelle J: Indochinese versions of the Hopkins Symptom Checklist-25: a screening instrument for the psychiatric care of refugees. Am J Psychiatry 1987, 144:497-500.
• [12]Weissman MM, Olfson M, Gameroff MJ, Feder A, Fuentes M: A comparison of three scales for assessing social functioning in primary care. Am J Psychiatry 2001, 158:460-466.
• [13]Hamilton M: A rating scale for depression. J Neurol Neurosurg Psychiatry 1960, 23:56-62.