Phase 4
Completed N=36
Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial
Source: ClinicalTrials.gov NCT01178671 ↗Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Feb 2016
Primary outcomePrimary: PTSD Severity — 23.8; 34.6 units on a scale — p=0.17
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY PTSD Severity |
23.8; 34.6 | 0.17 |
| PRIMARY Time to Discontinuation of Study Treatment |
95.2; 90.0 | 0.82 |
| SECONDARY Alternative Measure of PTSD Severity |
3.4; 6.7 | .14 |
| SECONDARY PTSD Self-rated Severity |
33.2; 39.2 | .50 |
| SECONDARY Depression Severity |
6.4; 11.6 | 0.023 sig |
| SECONDARY Response Status |
56; 22 | 0.31 |
| SECONDARY Remission Status |
39; 11 | 0.042 sig |
| SECONDARY Adverse Effects |
22.2; 33.3 | 0.14 |
| SECONDARY Sleep Quality |
4.4; 9.1 | 0.21 |
| SECONDARY Sexual Functioning |
16.3; 17.4 | 0.65 |
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT01178671). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.