The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy

Depression Clinical Trial

— PTF3  

Official title:

The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01569685
• Other study ID #: PTF3
• Status: Completed
• Phase: Phase 4
• First received: March 28, 2012
• Last updated: March 3, 2015
• Start date: April 2012
• Est. completion date: October 2014

Study information

• Verified date: March 2015
• Source: Psychiatric Center Ballerup
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Ethics CommitteeDenmark: Danish Dataprotection AgencyDenmark: Danish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Description:

Please see the summary above

Recruitment information / eligibility

• Status: Completed
• Enrollment: 207
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Post Traumatic Stress Disorder
• Stress Disorders, Post-Traumatic
• Stress Disorders, Traumatic

Intervention

Drug:
• Venlafaxine
Tablets, once a day, max 375 mg day (maximal recommended dose)
• Sertraline
Tablets, once a day, maximum 200 mg/day (maximum required dose)

Locations

Country	Name	City	State
Denmark	Competence Center for Transcultural Psychiatry	Gentofte

Sponsors (2)

Lead Sponsor	Collaborator
Charlotte Sonne	Psychiatric Center Ballerup

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Harvard Trauma Questionnaire (HTQ)	Self administered Rating Scale	Change from baseline after aprox. 6 months treatment	No
Secondary	Hopkins Symptom Check List (HSCL-25)		Change from baseline after aprox. 6 months treatment	No
Secondary	Social Adjustment Scale Self Report (SAS-SR) short version		Change from baseline after aprox. 6 months treatment	No
Secondary	Hamilton Depresssion Scale (17 items)		Change from baseline after aprox. 6 months treatment	No
Secondary	Hamilton Anxiety Scale (14 items)		Change from baseline after aprox. 6 months treatment	No