TREATMENT OF SLEEP DISTURBANCES IN TRAUMA-AFFECTED REFUGEES – A RANDOMISED CONTROLLED TRIA

Phase 1

• Conditions: Posttraumatic Stress Disorder (PTSD); MedDRA version: 18.1Level: PTClassification code 10036316Term: Post-traumatic stress disorderSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2015-004153-40-DK
• Lead Sponsor: Competence Centre for Transcultural Psychiatry

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-11-13
• Last Update Posted: 25 May 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 230

Inclusion Criteria

• Adults (18 years or older)
• Refugees or persons who have been family reunified with a refugee
• PTSD pursuant to the ICD-10 research criteria
• Psychological trauma experienced outside Denmark in the anamnesis. Trauma is imprisonment or detention with torture (according to the UN 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
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 215
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 15

Exclusion Criteria

• Severe psychotic disorder (defined as patients with an ICD-10 diagnosis F2x and F30.1-F30.9). 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 neurodegenative 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

Study & Design

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