The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy
Status:
Completed
Trial end date:
2014-10-01
Target enrollment:
Participant gender:
Summary
Background: The treatment of traumatised refugees is one of the areas within the field of
psychiatry with the weakest evidence for the different types of treatment. This is a problem
for both patients and doctors as well as for society.
The treatment of choice today for Post Traumatic Stress disorder (PTSD) is antidepressants
from the subgroup of Selektive Serotonin Reuptake Inhibitors (SSRI), among these the drug
Sertraline. The evidence for the use of these drugs as treatment for chronically complex PTSD
in traumatised refugees is however very limited and a large part of the group is estimated to
be insufficiently treated with this type of medicine. Venlafaxine is an antidepressant from
the subgroup of dual action product which means that is works on several pathways in the
brain. Among others it influences the area in the brain that is responsible for the enhanced
anxiety and hyperarousal experienced by traumatised refugees and which is found to be
enlarged among patients suffering from PTSD.
All together there is not sufficient evidence to conclude which type of medical and
psychological treatment that is most efficient when it comes to the treatment of traumatised
refugees. Also there is a lack of studies which examines social functioning and the relation
between psychosocial resources and outcome from treatment. Furthermore there is a lack of
knowledge of predictors of treatment outcome for the individual patients. This study seeks to
produce some of this evidence.
Method: This study is expected to include approximately 150 patients randomised into two
different groups. The patients are treated with Setraline or Venlafaxine depending on the
group the randomised to. Patients in both groups are getting the same version of manual based
Cognitive Behavioural Therapy that is specially adapted to this group of patients. The
treatment period is 6-7 month. The trial endpoints are PTSD-and depression symptoms and
social functioning all measured on internationally validated ratings scales.
Furthermore the study will examine the relation between expected outcome of treatment from a
range of predictors and the actual treatment results for the individual patient.
Results: Altogether this study will bring forward new standards for clinical evaluation and
treatment of traumatised refugees and the results are expected to be used in reference
programmes/clinical guidelines.