Expired Study
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New York, New York 10032


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.


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.


NCT ID:

NCT01178671


Primary Contact:

Principal Investigator
Franklin Schneier, MD
New York State Psychiatric Institute


Backup Contact:

N/A


Location Contact:

New York, New York 10032
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: August 31, 2019

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