The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy (PTF3)

March 3, 2015 updated by: Charlotte Sonne

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Please see the summary above

Study Type

Interventional

Enrollment (Actual)

207

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Gentofte, Denmark, 2900
        • Competence Center for Transcultural Psychiatry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Drug: Venlafaxine
Tablets, once a day, max 375 mg day (maximal recommended dose)
Other Names:
  • 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
Drug: Sertraline
Tablets, once a day, maximum 200 mg/day (maximum required dose)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Harvard Trauma Questionnaire (HTQ)
Time Frame: Change from baseline after aprox. 6 months treatment
Self administered Rating Scale
Change from baseline after aprox. 6 months treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Hopkins Symptom Check List (HSCL-25)
Time Frame: Change from baseline after aprox. 6 months treatment
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
Change from baseline after aprox. 6 months treatment
Hamilton Depresssion Scale (17 items)
Time Frame: Change from baseline after aprox. 6 months treatment
Change from baseline after aprox. 6 months treatment
Hamilton Anxiety Scale (14 items)
Time Frame: Change from baseline after aprox. 6 months treatment
Change from baseline after aprox. 6 months treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Charlotte Sonne

Collaborators

Psychiatric Center Ballerup

Investigators

  • Principal Investigator: Charlotte K Sonne, MD, Psychiatric Center Ballerup

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2012

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

March 28, 2012

First Submitted That Met QC Criteria

March 30, 2012

First Posted (Estimate)

April 3, 2012

Study Record Updates

Last Update Posted (Estimate)

March 4, 2015

Last Update Submitted That Met QC Criteria

March 3, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PTF3

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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