Posttraumatic Stress Disorder (PTSD) MedDRA version: 18.1 Level: PT Classification code 10036316 Term: Post-traumatic stress disorder System Organ Class: 10037175 - Psychiatric disorders
Conditions
Interventions
Trade Name: Mianserine
Pharmaceutical Form: Tablet
INN or Proposed INN: mianserine hydrocloride
Other descriptive name: MIANSERIN HYDROCHLORIDE
Concentration unit: mg milligram(s)
Concentration type:
Sponsors
Competence Centre for Transcultural Psychiatry
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The overall aim of this study is to examine sleep enhancing treatment in refugees with PTSD in a randomised controlled trial. The objectives are: 1. To estimate treatment effects of IRT and mianserin on sleep quality, sleep length and nightmares compared to treatment as usual (TAU) at CTP (Se description below) 2. To study the relation between enhanced sleep, PTSD-symptoms, observer rated functioning and self-rated quality of life 3. To examine predictors for positive outcome of treatment ;Secondary Objective: Not applicable;Primary end point(s): Total score on Pittsburgh Sleep Quality Index (PSQI);Timepoint(s) of evaluation of this end point: 2018 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Harvard Trauma Questionnaire (HTQ). • The Disturbing dreams and Nightmare Severity Index (DDNSI) • Hopkins Symptom Check List-25 (HSCL-25) • WHO-5 • Global Assessment of functioning – Symptoms GAF-S and functioning GAF-F • Sheehan Disability Scale (SDS) • REM Sleep Behavior Disorder Screening Questionnaire (RBDSC) • Brief Pain Inventory short form (BPI) • The World Health Organization Disability Assessment Schedule (WHODAS 2.0) • Hamilton depression and anxiety scales (HAM A+D) • Actigraph measures ;Timepoint(s) of evaluation of this end point: 2018 | — |
Countries
Denmark
Contacts
Public ContactHinuga Sandahl
Competence Centre for Transcultural Psychiatry
Outcome results
None listed