Duloxetine for premenstrual dysphoric disorder: a pilot study.
OBJECTIVE
Premenstrual dysphoric disorder (PMDD) is a complex clinical syndrome that is notoriously difficult to treat. The purpose of the present study was to provide preliminary data on the effectiveness of duloxetine in PMDD.


METHODS
Fifty-five women with PMDD were treated with a 60 mg/day dosage of duloxetine for two menstrual cycles. Responses were assessed at first and second treatment cycle.


METHODS
Outcome measures included a visual analogue scale, the Zung Self-rating Scale for Depression, the Hamilton Depression Rating Scale, the Hamilton Anxiety Rating Scale and the Clinical Global Impressions Scale.


RESULTS
Fifty patients completed the trial. All had significant improvement of depression and anxiety and response, defined as a 50% decrease in daily symptom scores, occurred in 39 (78%) patients. The effects of active treatment were marked by the first active cycle of menstruation.


CONCLUSIONS
Duloxetine 60 mg/day was effective in reducing PMDD symptoms and generally well tolerated. Limitations of the study were open-label design and lack of placebo control. However, the results appeared to be strong and consistent across measures. Adverse events (nausea, insomnia, poor appetite) were low. Further studies are needed to confirm these results.
Mazza
Marianna
M
Catholic University of Sacred Heart, Institute of Psychiatry and Psychology, Mood Disorders Unit, Via Ugo De Carolis, 48 00136 Rome, Italy. marianna.mazza@rm.unicatt.it
Harnic
Desiree
D
Catalano
Valeria
V
Janiri
Luigi
L
Bria
Pietro
P
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D000328:Adult; D000339:Affect / Q000187:drug effects; D014151:Anti-Anxiety Agents / Q000009:adverse effects / Q000627:therapeutic use*; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001007:Anxiety / Q000209:etiology / Q000517:prevention & control*; D003863:Depression / Q000209:etiology / Q000517:prevention & control*; D000068736:Duloxetine Hydrochloride; D005260:Female; D006801:Humans; D010865:Pilot Projects; D011293:Premenstrual Syndrome / Q000150:complications / Q000188:drug therapy* / Q000523:psychology; D011569:Psychiatric Status Rating Scales; D017367:Selective Serotonin Reuptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use*; D012720:Severity of Illness Index; D013876:Thiophenes / Q000009:adverse effects / Q000627:therapeutic use*; D013997:Time Factors; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D014151:Anti-Anxiety Agents; D000928:Antidepressive Agents; D000068736:Duloxetine Hydrochloride; D017367:Selective Serotonin Reuptake Inhibitors; D013876:Thiophenes