Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01178671 · ClinicalTrials.gov registry record · Phase 4
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
A Phase 4 study of Posttraumatic Stress Disorder, sponsored by Research Foundation for Mental Hygiene.
- Completed
- Registry status
- Phase 4
- Development phase
- 38
- Enrollment target
- 1
- Study location
NCT01178671 is a Phase 4 study of Posttraumatic Stress Disorder that has completed, run by Research Foundation for Mental Hygiene. The registered enrollment target is 38 participants, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (66% lower). The trial reports 1 study location across 1 state.
The verdict
NCT01178671, a Phase 4 study of Posttraumatic 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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01178671
The ClinicalTrials.gov registry entry for NCT01178671 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 38 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 112-participant average among 117 other Posttraumatic Stress Disorder trials with a reported enrollment target (66% lower). The listed sponsor is Research Foundation for Mental Hygiene, which has 27 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Posttraumatic Stress Disorder appearing as the primary indexed condition, and to 3 interventions - of which Sertraline is the first listed.
NCT01178671 reports 1 study location spanning 1 distinct geographic area - top geographies include 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: Posttraumatic 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 Posttraumatic 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.
-
A Comparison of Prolonged Exposure Therapy, Pharmacotherapy, and Their Combination for PTSD
ACTIVE NOT RECRUITING · Phase 4
-
A Psychophysiologic Study of Weakening Traumatic Combat Memories With Post-Reactivation Propranolol
COMPLETED · Phase 4
-
A Study of Sertraline to Prevent PTSD
COMPLETED · Phase 4
-
An Open Label Pilot Study of Adjunctive Asenapine for the Treatment of Posttraumatic Stress Disorder
COMPLETED · Phase 4
-
Reducing Cannabis Overuse With Prazosin
COMPLETED · Phase 4
-
Insomnia Treatment and Cardiometabolic Health in Older Adults With Posttraumatic Stress Disorder
RECRUITING · NA
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.