The Clinical Relevance of Self-Reported Premenstrual Worsening of Depressive Symptoms in the Management of Depressed Outpatients: A STAR*D Report

Abstract

Objective: To determine the incidence, clinical and demographic correlates, and relationship to treatment outcome of self-reported premenstrual exacerbation of depressive symptoms in premenopausal women with major depressive disorder who are receiving antidepressant medication. Method: This post-hoc analysis used clinical trial data from treatment-seeking, premenopausal, adult female outpatients with major depression who were not using hormonal contraceptives. For this report, citalopram was used as the first treatment step. We also used data from the second step in which one of three new medications were used (bupropion-SR [sustained release], venlafaxine-XR [extended release], or sertraline). Treatmentblinded assessors obtained baseline treatment outcomes data. We hypothesized that those with reported premenstrual depressive symptom exacerbation would have more general medical conditions, longer index depressive episodes, lower response or remission rates, and shorter times-to-relapse with citalopram, and that they would have a better outcome with sertraline than with bupropion-SR. Results: At baseline, 66% (n = 545/821) of women reported premenstrual exacerbation. They had more general medical conditions, more anxious features, longer index episodes, and shorter times-to-relapse (41.3 to 47

Female Reproductive Life Cycle and Hormones: Methodology to Improve Clinical Trials

“…The majority of women with MDD experience worsening of depressive symptoms in the luteal phase of the menstrual cycle. 29 Baseline and endpoint assessments of mood may be confounded by premenstrual mood exacerbation, with potential impact on study results. It is plausible that luteal phase worsening could complicate the interpretation of primary outcome data in MDD trials if it is not included in statistical modeling, even in randomized trials.…”

Sex differences in anxiety and depression clinical perspectives

“…Premenstrual exacerbation of depression has been linked in several studies to shorter time to relapse (Haley et al, 2013). …”

Sex differences in antidepressant efficacy

“…For many women, severity of symptoms of existing depression increases in the premenstrual phase [37]. In data from the STAR*D trial, 66% of women reported premenstrual exacerbations in their symptoms [38]. Of note, this was associated with longer depressive episodes and shorter latency to relapse.…”