Luteal phase dosing with paroxetine controlled release (CR) in the treatment of premenstrual dysphoric disorder

Department of Psychiatry and Behavioural Neurosciences and Obstetrics and Gynecology, McMaster University, St Joseph's Hospital, Hamilton, Ontario, Canada.
American Journal of Obstetrics and Gynecology (Impact Factor: 4.7). 09/2005; 193(2):352-60. DOI: 10.1016/j.ajog.2005.01.021
Source: PubMed


This clinical trial evaluated luteal phase dosing with paroxetine controlled release (CR) (12.5 mg and 25 mg) in the treatment of premenstrual dysphoric disorder (PMDD).
A multicenter, randomized, double-blind, placebo-controlled, 3-arm, fixed-dose study of luteal phase dosing with paroxetine CR in the treatment of PMDD. Three hundred seventy-three patients with PMDD were randomly assigned into the study. The primary measure of efficacy was the change from baseline in the mean luteal visual analogue scale (VAS)-Mood score. Secondary efficacy measures included disorder-specific evaluations, global assessments of disease severity, and assessments of functional impairment. Adverse events were recorded throughout the trial.
Patients treated with either dose of paroxetine CR demonstrated significantly greater improvements on the primary efficacy measure (change from baseline in mean luteal phase VAS-Mood scores) and on the majority of secondary efficacy measures compared with patients randomly assigned to placebo.
For the treatment of PMDD, luteal phase dosing with 12.5 mg and 25 mg of paroxetine CR is effective and generally well tolerated.

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    • "Women with PMDD are also more likely to report physical symptoms such as bloating and breast tenderness (Di Giulio and Reissing, 2006; Hartlage et al., 2012) and irritability (Angst et al., 2001; Landen and Eriksson, 2003) as opposed to depressed mood (Bhatia and Bhatia, 2002). Additionally, treatment response to medications differs as women with PMDD report alleviation of symptoms almost immediately after administration of the serotonin reuptake inhibitors (SRIs; Steiner et al., 2005, 2008; Yonkers et al., 2006). "
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    ABSTRACT: Premenstrual dysphoric disorder (PMDD) is a chronic condition that significantly affects a woman's well-being on a monthly basis. Although co-occurrence of PMDD and major depressive disorder (MDD) is common, most studies examine whether women with PMDD are at risk for depression and investigations of PMDD in depressed women are scant. Therefore, the present study examined rates of PMDD in young depressed women. PMDD was assessed using a structured clinical interview (SCID-PMDD) in a sample of 164 young women with (n=85) and without (n=79) any history of depression. Rates of PMDD were elevated among women with MDD in this sample. This result held true regardless of participants' MDD status (current, lifetime or past history-only symptoms of MDD) and regardless of whether all or most DSM-IV-TR PMDD criteria were met. Sample size in the present study was relatively small, and daily diary data were not available to confirm a PMDD diagnosis. The current study highlights the need for clinicians to assess for PMDD in young female patients with major depression. Depressed women experiencing the added physical and psychological burden of PMDD may have a more severe disease course, and future studies will need to identify appropriate treatments for this subset of depressed women.
    Full-text · Article · Jun 2013 · Journal of Affective Disorders
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    • "Suggesting that the onset of action of SRIs in PMDD is relatively short, it however soon became evident that a marked symptomreducing effect can be achieved also when the treatment is restricted to the interval during which symptoms are normally present. Such treatment, which starts at the time of ovulation, and stops shortly after the beginning of menses, is usually referred to as intermittent treatment (Sundblad et al, 1993; Halbreich and Smoller, 1997; Steiner et al, 1997, 2005; Jermain et al, 1999; Cohen et al, 2002; Freeman et al, 2004; Landén et al, 2006). It should however be noted that all premenstrual complaints are not equally inclined to respond to intermittent SRI administration. "
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    ABSTRACT: Several studies suggest that serotonin reuptake inhibitors (SRIs) exert a more rapid effect when used for the treatment of symptoms such as anger and irritability then when used for depression, obsessive-compulsive disorder, or anxiety. In line with this, premenstrual irritability can be effectively dampened by intermittent administration of an SRI, from ovulation to menstruation, indicating an onset of action of 10 days or less. How fast this effect appears, in terms of hours or days, is of considerable theoretical interest, but has previously not been studied in detail. To explore this issue, 22 women with marked premenstrual irritability, who previously had responded to paroxetine, were given this compound during two menstrual cycles and placebo during one cycle in a double-blind, cross-over fashion. The women were asked to start medication in the midst of the luteal phase when irritability had been intense for 2 days. The paroxetine cycles differed significantly from the placebo cycle as early as 14 h after drug intake with respect to the number of subjects experiencing sustained reduction in irritability. When the different cycles were compared with respect to irritability-rating scores for each time of assessment, the difference was significant at day 3. The side effect nausea had an even more rapid onset (4 h), but usually disappeared within 4 days. To summarize, this controlled trial shows that an SRI reduces premenstrual irritability already within a few days after the onset of treatment.
    Full-text · Article · Aug 2008 · Neuropsychopharmacology: official publication of the American College of Neuropsychopharmacology
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    • "In addition, although both treatment strategies (continuous and intermittent) were found to have a similar treatment efficacy, it would still appear to be the case, however, that limited data as regards continuous versus intermittent dosing of SSRI have been presented and directly compared in the literature, as Steiner et al. reported in 2005. 6 Further, to the best of Correspondence address: Mei-Chun Hsiao, MD, Department of Psychiatry, Chang Gang Memorial Hospital, Tao-yuan, 333, Taiwan. "
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    ABSTRACT: Several trials have proved the efficacy of selective serotonin re-uptake inhibitors (SSRI) in the treatment of premenstrual dysphoric disorder (PMDD) in Western society. The SSRI can be administered continuously throughout the entire cycle or intermittently from ovulation to the onset of menstruation (luteal phase). The purpose of the present study was to compare continuous and intermittent paroxetine treatment in oriental PMDD women during 6 months follow up. Thirty-six subjects were evaluated and drug free for two menstrual cycles, and they received daily paroxetine (20 mg) for two further full cycles. They were then randomly divided into continuous or intermittent treatment groups (n = 16, 14) over the next four cycles. Responses were assessed every 2 weeks. Outcome measures included scores on the Prospective Record of the Impact and Severity of Menstrual Symptomatology (PRISM) calendar, Hamilton Rating Scale for Depression/Anxiety (HAMD/HAMA), and the Clinical Global Impression scale (CGI). All these women had significant improvements in the HAMA, HAMD, CGI, and PRISM calendar. The rate of response to paroxetine treatment lay between 50% and 78.6% in the continuous-treatment group, and 37.5-93.8% in the intermittent-treatment group, as determined at the study end-point. Limitations of the present study included the open-label design and the incorporation of a limited sample size. The present results indicate that paroxetine is effective in both continuous and intermittent treatment of oriental PMDD women, and that the effects of active treatment lasted for six consecutive treatment menstrual cycles.
    Full-text · Article · Mar 2008 · Psychiatry and Clinical Neurosciences
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