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Venlafaxine Works as Intermittent Therapy for Premenstrual Distress: Presented at APA

By Roberta Friedman, PhD

SAN FRANCISCO, CA -- May 26, 2003 -- Women with severe dysphoria in the days preceding menstruation can take venlafaxine just for a few days and still find relief, without risking a discontinuation syndrome.

The findings were reported here on May 22^nd at the 2003 Annual Meeting of the American Psychiatric Association.

Venlafaxine acts on both serotonin and noradrenaline. Lee Cohen, MD, an associate professor of psychiatry at Harvard University in Boston, Massachusetts, United States, said that the drug did not produce significant symptoms in women with premenstrual dysphoric disorder (PMDD) who stopped taking it after menses began and then resumed it in the luteal phase.

The study enrolled 124 women who reported symptoms of PMDD. To determine eligibility, the women tracked their symptoms. Symptoms had to be within the luteal phase, because "if they have [symptoms] all the time, then these women do not have PMDD," said Dr. Cohen.

Diagnosis was confirmed over 1 or 2 menstrual cycles, then the women were given a placebo for 1 cycle. Women who did not respond to placebo then took venlafaxine starting 14 days prior to when menstruation would begin. Dosing for this first part of the open trial was 37.5-75.0 mg a day. A second phase raised the dose to 75.0-112.5 mg if women responded only partially or not at all to the first phase.

Twenty subjects with confirmed PMDD completed the placebo cycle. Eight responded to placebo, leaving 12 subjects to participate in the venlafaxine phase(s).

One subject withdrew due to headache, and the remaining 11 subjects experienced a significant decrease in symptoms during venlafaxine treatment. These women had improved scores on the Clinical Global Impressions severity scale and the premenstrual tension rating scale (P<0.05 for both scales).

Selective serotonin reuptake inhibitors have been tested as intermittent therapies, Dr. Cohen said, but discontinuation syndrome has been a problem. Mild signs of discontinuation syndrome appeared in this study, including 3 instances of headache, 2 each of nausea and restless leg, and 1 each of insomnia and agitation.

No effects appeared on weight or blood pressure.

Wyeth funded the study.


[Study title: Intermittent Use of Venlafaxine Flexible Dose in the Treatment of PMDD. Abstract NR678]

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