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

• ClinicalTrials.gov Identifier: NCT01569685
• Recruitment Status: Completed
• First Posted: April 3, 2012
• Last Update Posted: March 4, 2015
• Sponsor: Charlotte Sonne
• Collaborator: Psychiatric Center Ballerup
• Information provided by (Responsible Party): Charlotte Sonne, Psychiatric Center Ballerup

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Post Traumatic Stress Disorder; Depression	Drug: Venlafaxine; Drug: Sertraline	Phase 4

Detailed Description:

Please see the summary above

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 207 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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

Arms and Interventions

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 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	Drug: Sertraline; Tablets, once a day, maximum 200 mg/day (maximum required dose)

Outcome Measures

Primary Outcome Measures :

1. Harvard Trauma Questionnaire (HTQ) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
   Self administered Rating Scale

Secondary Outcome Measures :

1. Hopkins Symptom Check List (HSCL-25) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
2. Social Adjustment Scale Self Report (SAS-SR) short version [ Time Frame: Change from baseline after aprox. 6 months treatment ]
3. Hamilton Depresssion Scale (17 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ]
4. Hamilton Anxiety Scale (14 items) [ Time Frame: Change from baseline after aprox. 6 months treatment ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.

• Responsible Party: Charlotte Sonne, Clinical assistent, MD, Psychiatric Center Ballerup
• ClinicalTrials.gov Identifier: NCT01569685
• Other Study ID Numbers: PTF3
• First Posted: April 3, 2012
• Last Update Posted: March 4, 2015
• Last Verified: March 2015

Keywords provided by Charlotte Sonne, Psychiatric Center Ballerup:

PTSD; Traumatic Stress; Depressions; Refugees

Additional relevant MeSH terms:

Depression; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Behavioral Symptoms; Mental Disorders; Trauma and Stressor Related Disorders; Sertraline; Venlafaxine Hydrochloride; Antidepressive Agents; Psychotropic Drugs; Serotonin Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Serotonin Agents; Physiological Effects of Drugs; Serotonin and Noradrenaline Reuptake Inhibitors; Antidepressive Agents, Second-Generation