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In the ongoing effort to offer effective, evidence-based support for trauma survivors, new research published this year explores the effect of a new combination of medication of patients with post-traumatic stress disorder (PTSD).

A research team from the University of Alabama, Birmingham (UAB) designed the study “Brexpiprazole and Sertraline Combination Treatment in Posttraumatic Stress Disorder” around this question:

Is brexpiprazole and sertraline combination treatment an efficacious, safe, and well-tolerated treatment for posttraumatic stress disorder (PTSD)?

To answer this question, researchers recruited a total of 416 adults – 74 percent female, 26 percent male, average age 37 – diagnosed with post-traumatic stress disorder (PTSD) and divided them into two groups for an 11-week test period:

  • Experimental group: this group received the new medication combination for PTSD, brexpiprazole + sertraline
  • Control group: this group received standard medication – sertraline – combined with a harmless placebo

Neither the researchers nor the participants knew which individuals were in each group, making this a double-blind, random controlled trial, which is the most effective approach for determining causality in an experiment. The primary outcome the researchers measured was any change in patient scores on the Clinician-Administered PTSD Scale (CAPS-5), a 20-item scale designed to measure the incidence, frequency, and severity of PTSD symptoms. In addition, researchers tracked any adverse reactions to the medications reported by participants.

Before we review the results of this study, we’ll share the latest data on PTSD prevalence, and review the medications most often prescribed for PTSD treatment.

PTSD: Prevalence and Standard Medications

We retrieved the most recent facts and figures on PTSD prevalence from The National Institute of Mental Health (NIMH):

  • Adults with PTSD diagnosis in the past 12 months: 5%
  • Adults diagnosed with PTSD ever during lifetime: 6%
  • Females, ever diagnosed: 8%
  • Males, ever diagnosed: 4%

Currently, there are only two medications approved by the Food and Drug Administration (FDA) for treating PTSD:

  1. Sertraline, a selective serotonin reuptake inhibitor (SSRI)
  2. Paroxetine, another SSRI

In addition, there are several medications currently in off-label use for treating PTSD. Off-label use means using a drug for a purpose other than that for which it was approved, when evidence shows it may be effective, and both patient and provider know and understand the risks and benefits of off-label use.

Off-label medications currently used to treat PTSD include:

Those off-label medications work well for some patients but are ineffective for others. The standard medications are also effective for many patients. Experimental data shows the following:

  • SSRI treatment for PTSD: 42% report inadequate treatment response
  • Inconsistent efficiency across trials for individual SSRIs

That’s why patients and providers use the off-label medications we list above. In some cases, providers have tried a medication combination for PTSD, using atypical antipsychotics (AAs), SSRIs, selective norepinephrine reuptake inhibitors (SNRIs), SSRIs + AAs, and SNRIs + AAs. That’s why the study we introduce above is important: it’s one of the first random controlled trials on medication combination conducted to test the effectiveness of an SSRI + an AA on PTSD symptoms.

Let’s take a look at the results.

Medication Combination and PTSD: Is it Effective?

As a reminder, the outcomes that interested the research team were simple. First, they measured any change in PTSD symptoms between the experimental group and control group, and second, they measured any adverse reactions to the medication combination for PTSD.

Here’s what they found.

Ten weeks after initiation, data showed the following:

  • Experimental group, brexpiprazole + sertraline:
    • 2-point reduction in PTSD severity, as measured by the CAPS-5
  • Control group, sertraline + placebo:
    • 6-point reduction in PTSD severity, as measured by the CAPS-5
  • Adverse events:
    • Nausea:
      • Experimental group: 12.2%
      • Control group: 11.7%
    • Fatigue:
      • Experimental group: 6.8%
      • Control group: 4.1%
    • Weight gain:
      • Experimental group: 5.9%
      • Control group: 1.5%
    • Drowsiness:
      • Experimental group: 5.4%
      • Control group: 2.6%

In addition, four percent of the experimental group and 10 percent of the control group dropped of the study due to adverse reactions to the medications.

Medication Combination and PTSD

The results of this study are good news for people with PTSD who haven’t experienced success with initial treatment with standard medication. This medication combination – brexpiprazole + sertraline – showed effective symptoms reduction for patients with PTSD, with a small percentage of adverse reactions that did not exceed previous published data on adverse events for these two medications.

Here’s how the study authors describe the outcome of this research:

“Results of this randomized clinical trial show that brexpiprazole + sertraline combination treatment statistically significantly improved PTSD symptoms vs sertraline + placebo, indicating its potential as a new efficacious treatment for PTSD.”

We’ll add this information to our knowledge base on PTSD treatment, and note that this medication combination may be an effective treatment option for our patients with PTSD.