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NCT01178671 · ClinicalTrials.gov registry record · Phase 4
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
A Phase 4 study of Post Traumatic Stress Disorder, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01178671: Completed Phase 4 study of Post Traumatic Stress Disorder, sponsored by Research Foundation for Mental Hygiene.
NCT01178671 is a Phase 4 study of Post Traumatic Stress Disorder that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 38 participants, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01178671, a Phase 4 study of Post Traumatic Stress Disorder, has completed, sponsored by Research Foundation for Mental Hygiene.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 38 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
PTSD severity will be measured by the Clinician-Administered Posttraumatic Stress Disorder Scale, from 0 (least severe) to 136 (most severe).
Conditions Studied
Interventions
- DRUG Sertraline
- DRUG Mirtazapine
- OTHER Sugar pill
Study Locations (1)
New York
- Anxiety Disorders Clinic, New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 38 participants |
| Start Date | 2010-07 |
| Est. Completion | 2014-06 |
| Phase | Phase 4 |
What the finished NCT01178671 record still lists
NCT01178671 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 38 participants, a relatively small participant target, below the 664-participant average among 262 other Post Traumatic Stress Disorder trials with a reported enrollment target (94% lower).
The record links to 1 condition, with Post Traumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Sertraline is the first listed.
NCT01178671 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01178671 about?
NCT01178671 is a clinical study titled "Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial". 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 inhibit...
What is the current status of trial NCT01178671?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 38 participants. The study started on 2010-07. Estimated completion is 2014-06.
What conditions does trial NCT01178671 study?
This clinical trial studies the following conditions: Post Traumatic Stress Disorder.
What interventions are being tested in trial NCT01178671?
The interventions under investigation include: Sertraline (DRUG), Mirtazapine (DRUG), Sugar pill (OTHER).
Who is sponsoring clinical trial NCT01178671?
This trial is sponsored by Research Foundation for Mental Hygiene, which has 27 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01178671 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Post Traumatic Stress Disorder
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01178671's enrollment target sits among peer trials
38 200th of 262 higher than 63 of 262 other Post Traumatic Stress Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Post Traumatic Stress Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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