Status:
COMPLETED
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
Lead Sponsor:
Research Foundation for Mental Hygiene, Inc.
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Posttraumatic Stress Disorder
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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...
Detailed Description
This double-blind randomized controlled trial was conducted from January 2011 to February 2014. To acquire a diverse sample, outpatients were recruited at an academic medical center and at a private m...
Eligibility Criteria
Inclusion
- Current primary diagnosis of chronic PTSD
- Fluent in English or Spanish
Exclusion
- 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.
Key Trial Info
Start Date :
July 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2014
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT01178671
Start Date
July 1 2010
End Date
June 1 2014
Last Update
April 8 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Anxiety Disorders Clinic, New York State Psychiatric Institute
New York, New York, United States, 10032