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

The treatment of traumatized refugees with Setraline versus Venlafaxine - a randomized trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2011-006228-19-DK

Enrollment

150

Registered

2012-03-20

Start date

2012-03-21

Completion date

Unknown

Last updated

2015-12-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Post traumatic stress disorder (PTSD) Depression MedDRA version: 17.0 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Sertralin Product Name: Sertralin Pharmaceutical Form: Coated tablet INN or Proposed INN: SERTRALINE CAS Number: 79617-96-2 Concentration unit: mg milligram(s) Concentration type: up to C

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
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). 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	—

Measure

Time frame

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). 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

Measure	Time frame
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. 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. ;Timepoint(s) of evaluation of this end point: Summer 2014	—

Measure

Time frame

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. 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. ;Timepoint(s) of evaluation of this end point: Summer 2014

—

Countries

Denmark

Contacts

Public ContactCTP

Competencecenter for Transcultural Psychiatry

charlotte.sonne@regionh.dk004538645178

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026