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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Psychiatric Center Ballerup
Information provided by (Responsible Party):
Charlotte Sonne, Psychiatric Center Ballerup
ClinicalTrials.gov Identifier:
NCT01569685
First received: March 28, 2012
Last updated: July 4, 2014
Last verified: July 2014
  Purpose

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 Intervention Phase
Post Traumatic Stress Disorder
Depression
Drug: Venlafaxine
Drug: Sertraline
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study

Resource links provided by NLM:


Further study details as provided by Psychiatric Center Ballerup:

Primary Outcome Measures:
  • Harvard Trauma Questionnaire (HTQ) [ Time Frame: Change from baseline after aprox. 6 months treatment ] [ Designated as safety issue: No ]
    Self administered Rating Scale


Secondary Outcome Measures:
  • Hopkins Symptom Check List (HSCL-25) [ Time Frame: Change from baseline after aprox. 6 months treatment ] [ Designated as safety issue: No ]
  • Social Adjustment Scale Self Report (SAS-SR) short version [ Time Frame: Change from baseline after aprox. 6 months treatment ] [ Designated as safety issue: No ]
  • Hamilton Depresssion Scale (17 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ] [ Designated as safety issue: No ]
  • Hamilton Anxiety Scale (14 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: April 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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:
  • Venlafaxine
  • 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)
Other Name: Sertraline

Detailed Description:

Please see the summary above

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01569685

Locations
Denmark
Competence Center for Transcultural Psychiatry
Gentofte, Denmark, 2900
Sponsors and Collaborators
Charlotte Sonne
Psychiatric Center Ballerup
Investigators
Principal Investigator: Charlotte K Sonne, MD Psychiatric Center Ballerup
  More Information

No publications provided by Psychiatric Center Ballerup

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Charlotte Sonne, Clinical assistent, MD, Psychiatric Center Ballerup
ClinicalTrials.gov Identifier: NCT01569685     History of Changes
Other Study ID Numbers: PTF3
Study First Received: March 28, 2012
Last Updated: July 4, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency
Denmark: Danish Medicines Agency

Keywords provided by Psychiatric Center Ballerup:
PTSD
Traumatic Stress
Depressions
Refugees

Additional relevant MeSH terms:
Depression
Depressive Disorder
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Behavioral Symptoms
Mood Disorders
Mental Disorders
Anxiety Disorders
Sertraline
Venlafaxine
Antidepressive Agents
Psychotropic Drugs
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Serotonin Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Serotonin Agents
Physiological Effects of Drugs
Antidepressive Agents, Second-Generation

ClinicalTrials.gov processed this record on August 28, 2014