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

• Status: Completed
• Trial end date: 2014-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Research Foundation for Mental Hygiene, Inc.
• Collaborator: National Institute of Mental Health (NIMH)
• Treatments: Mianserin; Mirtazapine; Serotonin Uptake Inhibitors; Sertraline

Criteria

Inclusion Criteria:

• Current primary diagnosis of chronic PTSD

• Fluent in English or Spanish

Exclusion Criteria:

• Past or current schizophrenia, schizoaffective disorder, organic mental disorder, bipolar disorder, or antisocial personality disorder.

• Substance abuse of dependence diagnosis in past 3 months

• Suicidal ideation or behavior in past 6 months that poses a significant danger.

• Medical illness that could significant increase risk of sertraline and mirtazapine treatment or assessment of response

• History of traumatic brain injury of greater than mild severity

• History of seizure disorder (except febrile seizure in childhood)

• Currently taking medication which has been effective for patient's PTSD.

• Inability to tolerate or unwillingness to accept a drug-free period prior to beginning the study for certain psychiatric medications.

• History of inability to tolerate sertraline or mirtazapine or inadequate response to an adequate trial of combined treatment.

• Pregnancy, lactation; for women of childbearing potential, not using an effective birth control method.

• Current cognitive-behavioral therapy. Any psychotherapy initiated within 3 months of beginning this study.