The treatment of traumatized refugees with Setraline versus Venlafaxine (two types of antidepressants) - a randomized trial.

• Conditions: Post traumatic stress disorder (PTSD)Depression; MedDRA version: 17.0Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2011-006228-19-DK
• Lead Sponsor: Psykiatrisk Center Ballerup

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-20
• Last Update Posted: 7 December 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

- Patients referred to Psychiatric traumaunit for refugees (PTF) between april 2012 and maj 2013
- Grown ups (18 years old or above)
- Symptoms of PTSD in accordance with the ICD-10 research criterias.
- Psychological traume in their past
- By doctor estimated to be motivated towards treatment
- Informed consent given
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 125
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 25

Exclusion Criteria

- Suffering from serious psychotic disorder (Defined as patients with a ICD-10 diagnose F2x and F30.1-F30.9)
- Current abuse of drugs or alcohol (F.1x.24-F1x.26)
- In need of admission to psychiatric facility
- Informed consent no given
- Pregnant or breat feeding

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To investigate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees.;Secondary Objective: To investigate if changes in self-reported social functioning has any correlation to changes in depression and PTSD symptoms rated on Hamiltons Depression and Anxiety scales, Hopkins Symptom Checklist (HSCL-25) and Harvard Trauma Questionnaire (HTQ). <br><br>To investigate to which extend doctors and psychologist initial estimation of expected benefit from treament correlates to the actual treament outcome.;Primary end point(s): To evaluate whether or not there is a difference in the treament effect of Venlafaxine and Sertraline on PTSD symptoms in traumatized refugees. Symptoms changes are evaluated on primarily on Havard Traume Questionnaire (HTQ) in both groups. The trial aims to include a number of 150 patients (75 in each group) as mentioned above.;Timepoint(s) of evaluation of this end point: Summer 2014

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): To evaluate whether changes in self-reported social functioning has any correlation to changes in depression and PTSD symptoms rated on Hamiltons Depression and Anxiety scales, Hopkins Symptom Checklist (HSCL-25) and Harvard Trauma Questionnaire (HTQ) in the participants included.<br><br>To evaluate to which extend doctors and psychologist initial estimation of expected benefit from treament actually correlates to the treament outcome for the patients included.<br>;Timepoint(s) of evaluation of this end point: Summer 2014