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Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

NCT01178671 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 38

Last updated 2016-04-08

Study results available
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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

Interventions

DRUG

Mirtazapine

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

DRUG

Sertraline

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

OTHER

Sugar pill

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

Sponsors & Collaborators

  • National Institute of Mental Health (NIMH)

    collaborator NIH

  • Research Foundation for Mental Hygiene, Inc.

    lead OTHER

Principal Investigators

  • Franklin Schneier, MD · New York State Psychiatric Institute

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-31
Primary Completion
2014-05-31
Completion
2014-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01178671 on ClinicalTrials.gov