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

NCT01569685 | Completed Phase 4 DMC

• 1 other identifier: PTF3
• Study Type: interventional
• Target: 207
• Locations: 1 country
• Sites: 1

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.

Conditions

Post Traumatic Stress Disorder; Depression

Keywords

PTSD; Traumatic Stress; Depressions; Refugees

Outcome Measures

Primary Outcomes (1)

• Harvard Trauma Questionnaire (HTQ)

  Self administered Rating Scale

  Change from baseline after aprox. 6 months treatment

Secondary Outcomes (4)

• Hopkins Symptom Check List (HSCL-25)

  Change from baseline after aprox. 6 months treatment

• Social Adjustment Scale Self Report (SAS-SR) short version

  Change from baseline after aprox. 6 months treatment

• Hamilton Depresssion Scale (17 items)

  Change from baseline after aprox. 6 months treatment

• Hamilton Anxiety Scale (14 items)

  Change from baseline after aprox. 6 months treatment

Study Arms (2)

Venlafaxine

ACTIVE COMPARATOR

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

Sertraline

ACTIVE COMPARATOR

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

Interventions

Venlafaxine DRUG

Tablets, once a day, max 375 mg day (maximal recommended dose)

Also known as: Efexor

Venlafaxine

Sertraline DRUG

Tablets, once a day, maximum 200 mg/day (maximum required dose)

Sertraline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Charlotte Sonne: lead
• Psychiatric Center Ballerup: collaborator

Study Sites (1)

Competence Center for Transcultural Psychiatry

Gentofte Municipality, 2900, Denmark

Location

Related Publications (2)

• 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.

  PMID: 27825327 DERIVED

• 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.

  PMID: 23663588 DERIVED

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Depression

Interventions

Venlafaxine Hydrochloride; Sertraline

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Phenethylamines; Ethylamines; Amines; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Lipids; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Polycyclic Compounds

Study Officials

• Charlotte K Sonne, MD

  Psychiatric Center Ballerup

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical assistent, MD

Study Record Dates

• First Submitted: March 28, 2012
• First Posted: April 3, 2012
• Study Start: April 1, 2012
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: March 4, 2015

Record last verified: 2015-03

Locations

DK (1)