At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 241 enrolled
Drug / intervention
Mianserin +1 moredrug
Likely dose
Mianserin 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Sleep Disturbances in Trauma-affected Refugees: A Randomised Controlled Trial
Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital·interventional·Posted May 4, 2016·Updated Sep 16, 2019
In Brief
A Phase 4 clinical trial evaluating Mianserin and Imagery Rehearsal Therapy for Post Traumatic Stress Disorder and Depression. Completed, enrolled 241 participants across 1 site.
Detailed Summary
The overall aim of this study is to examine the effects of sleep enhancing treatment in refugees with PTSD.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPost Traumatic Stress Disorder, Depression
CountriesDenmark
CollaboratorsDanish Center for Sleep Medicine
Timeline
Phase 4CompletedFinished
20162017201820192020202120222023202420252026
Enrollment StartMar 2016
First PostedMay 2016
Primary CompletionJun 2019
TodayJul 2026
First PostedMay 4, 2016
Enrollment StartMar 1, 2016
Primary CompletionJun 1, 2019
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 10.2 years ago
Interventions
Mianserindrug
mianserin is add-on treatment to treatment as usual. Max dose 30 mg day.
Imagery Rehearsal Therapybehavioral
IRT is add-on treatment to treatment as usual.