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Clinical Trial
. 1997 Jul-Aug;25(4):235-42.

[Premenstrual dysphoric disorder: long-term treatment with fluoxetine and discontinuation]

[Article in Spanish]
Affiliations
  • PMID: 9412162
Clinical Trial

[Premenstrual dysphoric disorder: long-term treatment with fluoxetine and discontinuation]

[Article in Spanish]
J J de la Gándara Martín. Actas Luso Esp Neurol Psiquiatr Cienc Afines. 1997 Jul-Aug.

Abstract

Introduction: Premenstrual Dysphoric Disorder (PMDD) is characterized by debilitating mood and behavioral changes in the weed preceding menstruation that interfere with normal functioning. The diagnosis requires that symptoms be recurrent and persistent. We report here the results of an open-label study with 20 patients with PMDD according DSM-IV with and without a concomitant diagnosis of MDD (Major Depression) treated with fluoxetine during 6 and 18 months.

Method: 9 patients with PMDD and MDD, and 11 patients only with PMDD were treated with fluoxetine 20 mg/d during 6 months. After that, 9 women continued treatment until complete 18 months of treatment and 11 women discontinued by their own decision, because the complete absence of symptomatology. Women who discontinued treatment were followed at the 18 months to the assessment of the evolution. The efficacy was assessed by CGI, HAMA, HAMD and un TDP scale monthly during the first 6 month and in the visit at 18 month.

Results: All patients completed the 6 months of treatment with a good tolerance. The most common adverse events were decrease of the libido, gastric complains, nervousness and insomnia. These events were mild and don't produce any withdrawn. There were a significant change in all scales at 6 month assessment: HAM-D (22.4 vs. 5.3, p < 0.000), HAM-A (23.8 vs 8.7, p < 0.000) and TDP (36.4 vs. 18, p < 0.000). There weren't differences among patients with and without concomitant diagnosis of MDD. Among patients who continued taking fluoxetine the improvement was maintained at the 18 month-assessment. Patients who discontinued treatment with fluoxetine after 6 months suffered a worsening in their symptomatology at the 18 month assessment (CGI = 3.18 vs. CGI = 4.81, p < 0.005).

Conclusions: Fluoxetine is an effective and well-tolerated treatment for the long treatment of PMDD. The remission is maintained at least during 18 month of treatment. Symptomatology reappears after treatment discontinuation in most of the women.

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