Post Traumatic Stress DisorderPhase 4PTF3NCT01569685
The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy
A Phase 4 study testing Venlafaxine and Sertraline in people with Post Traumatic Stress Disorder and Depression, run by Charlotte Sonne at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Traumatic Stress Disorder, Depression
- What is being tested?
- Venlafaxine and Sertraline
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2012to Oct 2014
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Competence Center for Transcultural Psychiatry
Gentofte Municipality, 2900
About this study
Official title: The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study
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.
Read more
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.
Read the detailed description
Please see the summary above
- Conditions
- Post Traumatic Stress Disorder, Depression
- Being tested
- Venlafaxine, Sertraline
- Keywords
- PTSD, Traumatic Stress, Depressions, Refugees
- Medical subject headings
- Stress Disorders, Post-Traumatic, Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VenlafaxineDrug
Also called Efexor
Tablets, once a day, max 375 mg day (maximal recommended dose)
SertralineDrug
Tablets, once a day, maximum 200 mg/day (maximum required dose)
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Sertraline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Harvard Trauma Questionnaire (HTQ)
Self administered Rating Scale
Measured: Change from baseline after aprox. 6 months treatment
Secondary outcomes (4)
Hopkins Symptom Check List (HSCL-25)
Measured: Change from baseline after aprox. 6 months treatment
Social Adjustment Scale Self Report (SAS-SR) short version
Measured: Change from baseline after aprox. 6 months treatment
Hamilton Depresssion Scale (17 items)
Measured: Change from baseline after aprox. 6 months treatment
Hamilton Anxiety Scale (14 items)
Measured: Change from baseline after aprox. 6 months treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2012 (estimated)
- Study startApr 2012
- Primary completionOct 2014
- Study completionOct 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Post Traumatic Stress DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 207 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charlotte Sonne
- Sponsor type
- University, hospital or other
- Collaborators
- Psychiatric Center Ballerup
- Responsible party
- Sponsor-investigator, Charlotte Sonne, Psychiatric Center Ballerup
- Investigators
- Charlotte K Sonne, MD, Principal investigator, Psychiatric Center Ballerup
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01569685
- Sponsor's protocol ID
- PTF3
- Acronym
- PTF3
- Status last verified
- Mar 2015
- First submitted
- 28 Mar 2012
- Last updated
- 4 Mar 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 27825327Sonne 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.
PubMed 23663588
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Treatment of Traumatised Refugees With Sertraline Versus Venlafaxine in Combination With Psychotherapy - a Randomised Clinical Study
- ClinicalTrials.gov ID
- NCT01569685
- Acronym / sponsor ID
- PTF3 / PTF3
- Conditions
- Post Traumatic Stress Disorder, Depression
- Keywords
- PTSD, Traumatic Stress, Depressions, Refugees
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 207 participants (actual)
- Lead sponsor
- Charlotte SonneUniversity, hospital or other
- Collaborators
- Psychiatric Center Ballerup
- Study start
- Apr 2012
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 3 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Please see the summary above
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Venlafaxine | Active comparator | Drug: Venlafaxine6 months treament vith Venlafaxine (if patient has troubles sleeping in combination with Mianserine) in recommended dose in combination with Cognitive Behavioral Therapy |
| Sertraline | Active comparator | Drug: Sertraline6 months treament vith Sertraline (if patient has troubles sleeping in combination with Mianserine) in recommended dose in combination with Cognitive Behavioral Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VenlafaxineAlso: EfexorTablets, once a day, max 375 mg day (maximal recommended dose) | Drug | Venlafaxine |
| SertralineTablets, once a day, maximum 200 mg/day (maximum required dose) | Drug | Sertraline |
Primary outcome
Harvard Trauma Questionnaire (HTQ)
Time frame: Change from baseline after aprox. 6 months treatment
Self administered Rating Scale
4 secondary outcomes
Hopkins Symptom Check List (HSCL-25)
Time frame: Change from baseline after aprox. 6 months treatment
Social Adjustment Scale Self Report (SAS-SR) short version
Time frame: Change from baseline after aprox. 6 months treatment
Hamilton Depresssion Scale (17 items)
Time frame: Change from baseline after aprox. 6 months treatment
Hamilton Anxiety Scale (14 items)
Time frame: Change from baseline after aprox. 6 months treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2015.
- Derived from this study: PubMed 27825327Sonne 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.
- Derived from this study: PubMed 23663588Sonne 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Charlotte K Sonne, MD principal investigator
Psychiatric Center Ballerup
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Venlafaxine and Sertraline in people with Post Traumatic Stress Disorder and Depression, run by Charlotte Sonne at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Harvard Trauma Questionnaire (HTQ) (time frame: Change from baseline after aprox. 6 months treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01569685, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2015.