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SNRI Reboxetine Safe and Effective Adjunct for SSRI Fluoxetine Partial Responders in Major Depression: Presented at ECNP

By Bruce Sylvester
Special to DG News

BARCELONA, SPAIN -- October 8, 2002 -- Augmentation of fluoxetine therapy with reboxetine for the treatment of partial responders is safe, tolerable and effective, researchers reported at the 15th Congress of the European College of Neuropsychopharmacology.

"This study indicates the importance of more research into the efficacies of reboxetine. Reboxetine appears to boost the efficacy of fluoxetine for patients whose therapy needs just this kind of safe boost before they get discouraged, quit and head toward probable relapse," said Mark Rapaport, MD, professor of psychiatry at the University of California at San Diego Medical School.

"The aim of this 8-week, open-label study was to examine the efficacy and safety of augmenting existing SSRI therapy with the selective NRI reboxetine (4-8 mg/day) for patients with MDD who responded partially to 6 weeks therapy with fluoxetine (20 mg/day)," the investigative team reported.

"Many patients (29-46%) do not respond adequately to their first-line agent," they continued. "For partial responders to a selective serotonin reuptake inhibitor (SSRI) augmentation with an agent of a different pharmacological class such as a selective norepinephrine reuptake inhibitor (selective NRI) has been suggested as a potentially useful strategy."

The researchers enrolled 33 subjects (ages 18-65 years, mean 43.8 years) diagnosed with major depressive disorder by DSM-IV criteria who had experienced a partial response to 6 weeks therapy with fluoxetine (20 mg/day).

"Partial response" was defined as a HAM-D 17-item score greater than or equal to 14 points or less than or equal to a 40 percent decrease in the estimated SSRI pre-treatment score.

The investigators measured the efficacy of the adjunct treatment using the HAM-D 17-item rating scale. They rated tolerability by clinical observation and reporting by patients.

Twenty-six subjects (79 percent) finished the 8 weeks of the study. Six patients withdrew due to adverse events. One withdrew due to an unintended pregnancy.

Between baseline and the mean HAM-D 17-item total score decreased from 18.2 to 10.9 points.

By week 8 and among the 33 original subjects, 39.4 percent (13 subjects) became "responders" to the combination therapy (mean decrease in HAM-D 17-item total score greater than or equal to 50%). And 36.4 percent (12 subjects) achieved "remission" (HAM-D 17-item total score less than or equal to 8 points).

The drug combination was well tolerated. Adverse events were insomnia, dry mouth, constipation and diaphoresis, most of which were mild to moderate and temporary.

"The addition of the selective NRI reboxetine (4-8 mg/day) proved to be an effective and well tolerated strategy for adult patients who responded partially to 6 weeks fluoxetine therapy (20mg/day)," concluded the investigators.

The study was supported by Pharmacia Corporation.

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