Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:54 PM
Ignite Modification Date:
2025-12-24 @ 12:54 PM
NCT ID:
NCT02761161
Eligibility Criteria:
Inclusion Criteria:
* Adults (18 years or older)
* Refugees or persons who have been family reunified with a refugee
* PTSD pursuant to the International Classification of Diseases ICD-10 research criteria
* Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the United Nation definition of torture) or acts of cruel, inhuman and degrading treatment or punishment. Trauma can also be organised violence, long-term political persecution and harassment, or war and civil war experiences.
* Sleep disturbances/ PSQI \>8
* Nightmares/ HTQ score on nightmare item ≥ "a little"
* Signed informed consent
Exclusion Criteria:
* Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F31.9). Patients are excluded only if the psychotic-like experiences are assessed to be part of an independent psychotic disorder and not part of a severe PTSD and/or depression
* Current abuse of drugs or alcohol (F1x.24-F1x.26)
* Known neurodegenerative disorder (Alzheimer's disease (AD), Parkinson's disease (PD), Levy-Body dementia (LBD))
* In need of admission to psychiatric hospital
* Pregnant and breastfeeding women and women of the reproductive age who wish to conceive during the project period.
* Allergy towards active ingredients or excipients in mianserin
* Lack of informed consent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02761161
Study Brief:
Protocol Section:
NCT02761161