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Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial - NCT01178671-10032(Clinical Trial 722038)



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City:  New York
State:  
NY
Zip Code: 10032
Conditions: Posttraumatic Stress Disorder
Purpose: 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 summary:
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.
Study is available at: Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, NY 10032
United States

Primary Contact:
Jose Hernandez
Email: jose@nyspi.cpmc.columbia.edu
Phone: 212-543-5367
If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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Data Source: ClinicalTrials.gov
Date Processed: March 23, 2011
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