The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy (PTF3)
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|ClinicalTrials.gov Identifier: NCT01569685|
Recruitment Status : Completed
First Posted : April 3, 2012
Last Update Posted : March 4, 2015
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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.
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder Depression||Drug: Venlafaxine Drug: Sertraline||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||207 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study|
|Study Start Date :||April 2012|
|Actual Primary Completion Date :||October 2014|
|Actual Study Completion Date :||October 2014|
Active Comparator: Venlafaxine
6 months treament vith Venlafaxine (if patient has troubles sleeping in combination with Mianserine) in recommended dose in combination with Cognitive Behavioral Therapy
Tablets, once a day, max 375 mg day (maximal recommended dose)
Other Name: Efexor
Active Comparator: Sertraline
6 months treament vith Sertraline (if patient has troubles sleeping in combination with Mianserine) in recommended dose in combination with Cognitive Behavioral Therapy
Tablets, once a day, maximum 200 mg/day (maximum required dose)
- Harvard Trauma Questionnaire (HTQ) [ Time Frame: Change from baseline after aprox. 6 months treatment ]Self administered Rating Scale
- Hopkins Symptom Check List (HSCL-25) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
- Social Adjustment Scale Self Report (SAS-SR) short version [ Time Frame: Change from baseline after aprox. 6 months treatment ]
- Hamilton Depresssion Scale (17 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
- Hamilton Anxiety Scale (14 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01569685
|Competence Center for Transcultural Psychiatry|
|Gentofte, Denmark, 2900|
|Principal Investigator:||Charlotte K Sonne, MD||Psychiatric Center Ballerup|
|Responsible Party:||Charlotte Sonne, Clinical assistent, MD, Psychiatric Center Ballerup|
|Other Study ID Numbers:||
|First Posted:||April 3, 2012 Key Record Dates|
|Last Update Posted:||March 4, 2015|
|Last Verified:||March 2015|
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Trauma and Stressor Related Disorders
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Serotonin and Noradrenaline Reuptake Inhibitors
Antidepressive Agents, Second-Generation