Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo-Controlled Trial

Cohen, Lee S.; Soares, Cláudio N.; Yonkers, Kimberly A.; Bellew, Kevin M.; Bridges, Ian; Steiner, Meir

doi:10.1097/01.psy.0000140005.94790.9c

Cited by 64 publications

(38 citation statements)

References 20 publications

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“…In line with previous studies (Eriksson et al, 1995;Cohen et al, 2004), paroxetine was found to be very effective for PMDD. In the ITT population of the PC group, the median percentage reduction in self-rated intensity of all four cardinal symptoms hence was above 90%.…”

Section: Discussionsupporting

confidence: 78%

“…Moreover, 80% of the subjects in this group stated that they would like to go on taking this compound. In line with previous SRI studies (Pearlstein et al, 2000;Cohen et al, 2002;Steiner et al, 2003;Cohen et al, 2004), the treatment also resulted in improved social functioning. Previous authors have emphasized that there is a considerable portion of nonresponders to SRIs among PMDD subjects (van Leusden, 1995).…”

Section: Discussionsupporting

confidence: 71%

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Placebo-Controlled Trial Comparing Intermittent and Continuous Paroxetine in Premenstrual Dysphoric Disorder

Landén

Nissbrandt

Allgulander

et al. 2006

Neuropsychopharmacol

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Serotonin reuptake inhibitors (SRIs) do not have to be administered continuously to be effective for premenstrual dysphoric disorder (PMDD), but can be given during luteal phases only. This is of practical importance, but also of theoretical interest since it suggests that the onset of action of SRIs is shorter in PMDD than in, for example depression. In this study, both continuous and intermittent SRI administration was compared with placebo, with the special purpose of analyzing if different PMDD symptoms respond differently depending on the treatment regimen. To this end, women meeting slightly modified DSM-IV criteria for PMDD (mean7SD age, 3776.3 years) were treated for three menstrual cycles with paroxetine continuously, paroxetine during the luteal phase only, or placebo, the population completing at least one treatment cycle comprising 55-56 subjects per group. Continuous treatment with paroxetine reduced premenstrual symptoms effectively with a response rate of 85%. The effect size was highest for irritability (1.4) and lowest for lack of energy (0.5). Intermittent treatment was as effective as continuous treatment in reducing irritability, affect lability, and mood swings, but had a somewhat weaker effect on depressed mood and somatic symptoms. The study indicates that the response rate when treating PMDD with SRIs is high, and that irritability is a key target symptom. Symptoms such as irritability, affect lability, and mood swings appear to be more inclined to respond rapidly to SRIs, enabling intermittent treatment, than are, for example, the somatic symptoms. Neuropsychopharmacology (2007) 32, 153-161.

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Section: Discussionsupporting

confidence: 78%

Section: Discussionsupporting

confidence: 71%

Placebo-Controlled Trial Comparing Intermittent and Continuous Paroxetine in Premenstrual Dysphoric Disorder

Landén

Nissbrandt

Allgulander

et al. 2006

Neuropsychopharmacol

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“…27 Our results are, on the other hand, in line with previous studies suggesting doses of paroxetine normally recommended for depression to be superior to lower doses for the treatment of PMDD. 25,48 Adverse events more common in the escitalopram-treated groups than in the placebo-treated groups were those that would be expected from treatment with an SSRI, such as nausea, fatigue, and dry mouth. Generally, the tolerability of escitalopram was good, as illustrated by the dropout rate due to AEs being not higher in the high-dose escitalopram group than in the placebo group.…”

Section: Discussionmentioning

confidence: 98%

Escitalopram Administered in the Luteal Phase Exerts a Marked and Dose-Dependent Effect in Premenstrual Dysphoric Disorder

Eriksson

Ekman²,

S³

et al. 2008

Journal of Clinical Psychopharmacology

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This is the first placebo-controlled trial evaluating the efficacy of the selective serotonin reuptake inhibitor (SSRI), escitalopram, in the treatment of premenstrual dysphoric disorder (PMDD). Women with PMDD (intention-to-treat population, n = 151) were treated intermittently for 3 months, during luteal phases only, with 10 mg/d escitalopram, 20 mg/d escitalopram, or placebo. Escitalopram was found to exert a marked and a dose-dependent symptom-reducing effect, 20 mg/d being clearly superior to 10 mg/d. Although the primary outcome parameter, that is, the sum of the symptoms irritability, depressed mood, tension, and affective lability, was decreased by 90% with 20 mg/d escitalopram, the effect of active treatment on breast tenderness, food craving, and lack of energy was more modest and not significantly different from that of placebo; this outcome supports our previous assumption that the former symptoms are more inclined to respond to intermittent administration of an SSRI than are the latter. Although the placebo response was high, the difference between the placebo group and the 20-mg/d escitalopram group with respect to the percentage of subjects displaying 80% or greater reduction in the rating of the cardinal symptom of PMDD, that is, irritability, was considerable: 30% versus 80%. Adverse events were those normally reported in SSRI trials, such as nausea and reduced libido, and were not more common in patients given 20 mg/d of escitalopram than in patients given the lower dose. This study supports the usefulness of escitalopram for the treatment of PMDD and sheds further light on how different components of this syndrome are differently influenced by intermittent administration of an SSRI.

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“…Sertraline starting dose is 25-50 mg/day up to 150 mg/day; however, most women required 100 mg/day [75]. Paroxetine continuous release dose is 12.5-25 mg/day; paroxetine dose is 10-30 mg and citalopram is 5-20 mg. Higher doses (100 mg sertraline or 25 mg paroxetine continuous release) were required for treating the physical symptoms of PMDD [71,76].…”

Section: Treatment: Serotonergic Agents Including Selective Serotoninmentioning

confidence: 99%

Premenstrual syndrome and premenstrual dysphoric disorder in adolescents

Rapkin

Mikacich²

2008

Current Opinion in Obstetrics &Amp; Gynecology

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Paroxetine Controlled Release for Premenstrual Dysphoric Disorder: A Double-Blind, Placebo-Controlled Trial

Abstract: Both doses of paroxetine CR 12.5 mg and 25 mg daily are effective and well tolerated in patients who suffer from PMDD. Efficacy with both doses affords greater flexibility to the prescribing physician.

Cited by 64 publications

References 20 publications

Placebo-Controlled Trial Comparing Intermittent and Continuous Paroxetine in Premenstrual Dysphoric Disorder

Placebo-Controlled Trial Comparing Intermittent and Continuous Paroxetine in Premenstrual Dysphoric Disorder

Escitalopram Administered in the Luteal Phase Exerts a Marked and Dose-Dependent Effect in Premenstrual Dysphoric Disorder

Premenstrual syndrome and premenstrual dysphoric disorder in adolescents

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