FDA-Approved Drug Works for Posttraumatic Stress Disorder

April 11, 2000 (New York) -- If you suffer from posttraumatic stress disorder, you've probably tried both counseling and medication -- without much success. As many as 8% of all Americans will at some time suffer from the difficult to treat disorder that occurs in people exposed to extremely stressful events that evoke intense fear, according to the Anxiety Disorders Association of America.

But hope may be on your horizon. A study in the April 12 issue of the Journal of the American Medical Association shows that more than 50% of patients suffering from long-standing posttraumatic stress disorder (PTSD) responded favorably within two weeks of treatment with the antidepressant Zoloft (sertraline).

Symptoms of the disorder, such as severe anxiety, flashbacks of the stressful event, nightmares, and attempts to avoid things that are reminders of the event, can persist throughout your life. However, in addition to symptom relief, the people in the study taking Zoloft reported improvements in overall functioning and quality of life.

"[Zoloft] is the first drug that has ever been approved for the treatment of PTSD anywhere in the world," says study co-author Kathleen Brady, MD, PhD, of the Medical University of South Carolina in Charleston. "Our findings really legitimize the disorder. It's a real disorder that can be treated." In December 1999, the FDA approved Zoloft for the treatment of PTSD.

"This is one of two studies that led the FDA to approve sertraline for the treatment of PTSD," says Matthew J. Friedman, MD, executive director of the National Center for PTSD and a professor at Dartmouth Medical School in Hanover, N.H. Friedman, who is also a member of the scientific advisory board of Pfizer, reviewed the study for WebMD. Pfizer, which manufactures Zoloft, funded the study.

Duke University's Michael A. Hertzberg agrees that the study makes a case for adding drugs in the Zoloft family to the list available treatment options. "This study solidifies most clinician's thinking that you'd start with [one of the drugs in the Zoloft family] as the medication of first choice for PTSD. It doesn't prove [Zoloft] is the best drug for PTSD ... but it's an impressive response," he says. Hertzberg is director of the PTSD program at the Durham VA Hospital in North Carolina.

"PTSD is a chronic and debilitating disorder that affects a surprisingly large number of people," says David Tolin, PhD, of the Center for the Treatment and Study of Anxiety in Philadelphia. "Therefore, it's extremely important for us to have effective and efficient treatments that can alleviate its symptoms. With the addition of sertraline to the available treatments, this should help a large number of PTSD sufferers."

In this study, patients received either sertraline or a sugar pill, called a placebo, for 12 weeks. Physicians used rating scales to determine if there were changes in symptoms and also to determine if there was overall improvement in the patients' quality of life and symptoms of depression, which are common in PTSD.

At the end of the trial, 53% of the participants had responded to the medication. "Not only did the medication decrease symptoms significantly compared to placebo, but also people seemed to be able to live their lives more fully with this treatment," says Brady.

Sertraline was generally well tolerated by the patients, although insomnia was a significant problem for 16% of them. Patients also lost more weight with sertraline than the placebo during the trial.

"In terms of the literature, this is the largest and most conclusive study yet published, but there are a number of drugs that also show promise. There's just not as much evidence to support their use as was provided for this drug," Friedman tells WebMD.

"I'd call the findings exciting but I would not call it a miracle," says Tolin. He notes that although patients in the study got better, many remained symptomatic even after sertraline treatment.

Tolin also points out that other therapies, such as cognitive behavior therapy, are also helpful for PTSD. He says he expects other companies will seek FDA approval for their PTSD medications within the next few years. "It is likely that we'll find different treatments can be used concurrently to provide maximal effects," says Tolin.

Vital Information:

  • A new study shows that the antidepressant Zoloft (sertraline) may be effective against posttraumatic stress disorder (PTSD), improving symptoms, overall functioning, and quality of life.
  • Symptoms did not completely disappear with the drug treatment, and insomnia was reported as a side effect in some patients.
  • Other types of therapy are available to treat PTSD, such as cognitive behavioral therapy, and a combination of treatments may be the best approach.