CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 38 enrolled
Drug / intervention
Mirtazapine +2 moredrug
Likely dose
Mirtazapine 45 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/NCT01178671
NCT01178671Phase 4Completed

Combined Mirtazapine and Selective Serotonin Reuptake Inhibitor (SSRI) Treatment of Post-traumatic Stress Disorder (PTSD)

Research Foundation for Mental Hygiene, Inc.·interventional·Posted Aug 10, 2010·Updated Apr 8, 2016

In Brief

A Phase 4 clinical trial evaluating Mirtazapine, Sertraline, and 1 other intervention for Posttraumatic Stress Disorder. Completed, enrolled 38 participants across 1 site.

Detailed Summary

The overall goal of this study is to examine the efficacy of the combination of mirtazapine and sertraline in the treatment of posttraumatic stress disorder (PTSD). Sertraline is FDA-approved for PTSD, but it is often not fully effective. The combination of mirtazapine and serotonin reuptake inhibitors like sertraline has appeared highly effective in a related disorder -- depression. In this study, sixty patients with chronic PTSD will be randomized to treatment with either sertraline + mirtazapine or sertraline + placebo for 12 weeks. Patients who show at least a minimal response after 12 weeks will continue for another 12 weeks on the same treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 4CompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedAug 10, 2010
Enrollment StartJul 1, 2010
Primary CompletionMay 1, 2014
Study CompletionJun 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 15.9 years ago

Interventions

Mirtazapinedrug

Mirtazapine capsule, flexible dose of 15-45 mg/day for up to 24 weeks

Sertralinedrug

Sertraline tablet, flexible dose of 25-200mg/day for up to 24 weeks

Sugar pillother

Sugar pill capsule, flexible dose of 1-3 per day, for up to 24 weeks