CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 18 enrolled
Drug / intervention
Mirtazapine +1 moredrug
Likely dose
Mirtazapine 15 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.

Search/NCT04799782
NCT04799782Phase 2Completed

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

Wayne State University·interventional·Posted Mar 16, 2021·Updated Jun 15, 2021

In Brief

A Phase 2 clinical trial evaluating Mirtazapine and Placebo for Spinal Cord Injuries and Sleep Disordered Breathing. Completed, enrolled 18 participants.

Detailed Summary

The purpose of this study is to look at the effect of using Mirtazapine to target a specific pathway in the body, that relies on a natural chemical the body produces called 'serotonin', in patients with spinal cord injury (SCI) and non-injured persons during sleep. During this part of the study participants will be asked to take Mirtazapine (15mg per day) and a placebo in a random fashion, each for a one week period (drug period) of time followed by one week without drugs (washout period). The drugs will not be taken all at the same time, but each will be taken separately for one weeks followed by a night study to look at the effect the Mirtazapine/placebo pill has on the way the body responds during sleep.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

Phase 2CompletedFinished
2017201820192020202120222023202420252026
First PostedMar 16, 2021
Enrollment StartJan 1, 2017
Primary CompletionMay 18, 2019
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 5.3 years ago

Interventions

Mirtazapinedrug

15 mg dose before bed-time

Placebodrug

One placebo pill before bed-time