News Release

Patients with social phobia benefit from long-term treatment with sertraline HCl

Peer-Reviewed Publication

Porter Novelli

First multicenter study to demonstrate long-term efficacy of an antidepressant in preventing relapse

CHICAGO, IL, USA - 16 May 2000 - Therapy with the antidepressant sertraline HCl (ZOLOFT®) prevents relapse and the re-emergence of symptoms in patients with generalized social phobia, according to results from a 44-week study presented this week at the annual meeting of the American Psychiatric Association (APA).

"While we know the effectiveness of short-term treatment for patients with generalized social phobia, this study - the longest controlled follow-up to date- demonstrates that patients can benefit and reduce their risk of relapse from long-term treatment with sertraline," said lead investigator Michael Van Ameringen, M.D., FRCP(C), co-director of the Anxiety Disorders Clinic, McMaster University Medical Centre, Hamilton Health Sciences Corporation and assistant professor, Psychiatry and Neurosciences Medicine for McMaster University's Faculty of Health Sciences in Hamilton, Ontario, Canada.

Social phobia (also known as social anxiety disorder) is the third most common psychiatric disorder in the United States, after depression and alcohol dependence and affects one out of every eight Americans. The disorder is slightly more common in women than in men and may be hereditary, according to the American Psychiatric Association.

Social phobia is characterized by the fear of scrutiny by other people or by a persistent fear of humiliation or embarrassment in social or performance situations, which leads to either avoidance of the situation or feelings of intense distress during the situation. Common social phobic situations include speaking in public, meeting new people or eating in public. When put in these social situations, people with social phobia may experience symptoms including a rapid heartbeat, trembling, muscle tension or sweating, according to the American Psychiatric Association.

"Patients with generalized social phobia, who typically have been treated successfully for 20 weeks and risk relapse of their disorder if they stop medication, now can substantially benefit from staying on treatment with sertraline for nearly a year, as evidenced by these study results," said Van Ameringen.

Sertraline is a selective serotonin reuptake inhibitor (SSRI) and works by interfering with the body's recycling of serotonin, a naturally occurring chemical that nerve cells need to transmit electrical signals between them. Such neurotransmitters and signals play an important role in the brain's chemistry and control of moods, thoughts, feelings and sleep patterns, among other behaviors. Serotonin is critical in regulating the brain's control of anxiety, depression and aggression. For a person whose serotonin recycling is not balanced, sertraline can increase the availability of serotonin to help the brain regain control, according to Van Ameringen.

For this 24-week relapse prevention trial, investigators at 10 outpatient anxiety clinics in Canada enrolled 65 patients. All of the study participants were patients whose response to therapy was rated as "much improved" or "very improved" on the investigator-assessed Clinical Global Impression of Improvement (CGI-I) score during a previous 20-week placebo-controlled study that compared therapy with sertraline to placebo. The two studies combined followed patients through their treatment with sertraline or placebo for a total of 44 weeks.

At the beginning of the 24-week continuation study, investigators randomly assigned 50 patients who received sertraline during the initial trial to either continue sertraline (N=25) or switch to placebo (N=25). Neither the investigators nor the patients knew to which therapy the participants were assigned until the end of the trial.

The patients receiving sertraline comprised the sertraline-continuation group, and the patients who took placebo were in the placebo-switch group. An additional group, the placebo-responders, was composed of 15 patients who received placebo during the initial 20-week study and continued to receive placebo during the continuation study.

During the study, only one (4 percent) of the 25 people in the sertraline continuation group relapsed. In comparison, nine (36 percent) of the 25 people in the placebo-switch group relapsed at study endpoint. The relative risk (hazards ratio) for relapse associated with placebo switch compared to sertraline continuation treatment was 10.2. Moreover, the sertraline-continuation patients demonstrated significantly greater improvements compared to patients in the placebo-switch group on seven of nine secondary efficacy parameters that the investigators used to measure patients' symptoms. Placebo-switch patients had greater deterioration on the Sheehan Disability Inventory (SDI) Work,

Social/Leisure and Family/Home quality of life subscales, that achieved significance on the Work subscale.

Overall patients tolerated sertraline well. Eighty-eight percent (22) of the sertraline-continuation patients, 40 percent (10) of the placebo-switch group and 40 percent (6) of the placebo-responder patients completed the study.

The incidence and severity of side effects experienced by the sertraline-continuation patients generally did not differ from those reported by placebo-switch patients, except for significantly more headache and flu-like symptoms in the sertraline-continuation patients. However, none of the sertraline-continuation patients cited adverse experiences as their reason for discontinuing the study. No serious adverse events were reported.

Sertraline is approved in Canada, the United States and other countries for the treatment of depression, panic disorder and obsessive-compulsive disorder (OCD) in adults and OCD in children. Sertraline is also approved for the treatment of posttraumatic stress disorder (PTSD) in the United States.

Sertraline is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) medicine. MAOI medicines are used to treat depression and other conditions. A patient should never take sertraline at the same time as a MAOI. A patient must wait at least two weeks before switching from sertraline to a MAOI or from a MAOI to sertraline.

Some people taking sertraline may get side effects. The most common side effects of sertraline, across indications, include nausea, insomnia, diarrhea, ejaculatory delay and somnolence.

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Hamilton Health Sciences Corporation is Ontario's largest provider of comprehensive healthcare. HHSC operates four hospital sites - Chedoke campus, Hamilton General Hospital site, Henderson General Hospital site and McMaster University Medical Centre site as well as the Children's Hospital. Hamilton Health Sciences Corporation is the major regional provider of comprehensive health services for the 2.2 million people of Central-West Ontario. As a major academic health sciences center, HHSC is a partner with McMaster University and others in the education of future health professionals and the creation of new knowledge through research, and is committed to participating in the improvement of the health of the residents of Hamilton-Wentworth Region.

Pfizer Inc supported this research. Full prescribing information for sertraline HCl (ZOLOFT®) is available upon request.

Lena Montecalvo
Public Affairs Department
1200 Main Street West
Hamilton, Ontario
Canada L8N 3Z5
Phone: (905) 521-2100 ext. 76066 Fax: (905) 521-5090


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