Clinical trial NCT01569685: The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy
Official title: The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Post Traumatic Stress Disorder
Depression
Keywords: PTSD
Traumatic Stress
Depressions
Refugees
Lead sponsor: Psychiatric Center Ballerup
Sponsor class: OTHER
Collaborators: name: Psychiatric Center Ballerup
First posted: 2012-04-03
Enrollment: 207
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: Please see the summary above

Eligibility criteria: Inclusion Criteria:

* Patients referred to treatment in Psychiatric Clinic for refugees, Psychiatric Center Ballerup between April 2012 to May 2013
* Adults (18 years or older)
* Refugees or reunified with a refugee spouse
* Symptoms of PTSD defined by ICD-10 research criterias.
* Previosly traumatized
* Motivated for treatment
* Informed consent

Exclusion Criteria:

* Psychotic disorder (ICD-10 diagnosis F2x og F30.1-F309)
* Active substance abuse (ICD-10 F1x.24-F1x.26).
* In need of acute admission to psychiatric hospital)
* No informed consent
* Pregnant women, breastfeeding women or women who wish to become pregnant within the project period.

Primary outcomes:
measure: Harvard Trauma Questionnaire (HTQ)
timeFrame: Change from baseline after aprox. 6 months treatment
Secondary outcomes:
measure: Hopkins Symptom Check List (HSCL-25)
timeFrame: Change from baseline after aprox. 6 months treatment
measure: Social Adjustment Scale Self Report (SAS-SR) short version
timeFrame: Change from baseline after aprox. 6 months treatment
measure: Hamilton Depresssion Scale (17 items)
timeFrame: Change from baseline after aprox. 6 months treatment
measure: Hamilton Anxiety Scale (14 items)
timeFrame: Change from baseline after aprox. 6 months treatment
Other outcomes:
Locations:
city: Gentofte
country: Denmark
facility: Competence Center for Transcultural Psychiatry
Study officials:
affiliation: Psychiatric Center Ballerup
name: Charlotte K Sonne, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Sonne C, Carlsson J, Bech P, Elklit A, Mortensen EL. Treatment of trauma-affected refugees with venlafaxine versus sertraline combined with psychotherapy - a randomised study. BMC Psychiatry. 2016 Nov 8;16(1):383. doi: 10.1186/s12888-016-1081-5.
citation: Sonne C, Carlsson J, Elklit A, Mortensen EL, Ekstrom M. Treatment of traumatized refugees with sertraline versus venlafaxine in combination with psychotherapy - study protocol for a randomized clinical trial. Trials. 2013 May 11;14:137. doi: 10.1186/1745-6215-14-137.