RESUMO
BACKGROUND: Prevalence of premenstrual syndrome (PMS) may be as high as 13-18%, but it remains under-recognized and is associated with increased suicidal ideation (SI), plans, and attempts in epidemiological studies. The present study reports on women endorsing premenstrual SI (PMSI) and characterizes this at-risk group and its clinical correlates. METHODS: A cross-sectional study assessed demographics, anxiety and depression severity, psychiatric diagnoses, menstrual symptoms, SI, and trauma in adult women at a major medical center over 11 months. RESULTS: Three hundred two women were assessed. Of 153 participants endorsing premenstrual symptoms, 41 (27%) reported new or worsening concurrent premenstrual passive or active SI. Women who reported PMSI were significantly more likely to be single, unemployed, and childless as well as significantly more likely to report interference from premenstrual symptoms, histories of psychiatric hospitalization, adverse childhood events, suicide attempts, and current and past depression and anxiety compared to women without PMSI. The final regression model indicated the most significant predictors of PMSI were history of a depression diagnosis, severity of current depressive symptoms, and having experienced 3 or more childhood adverse events. CONCLUSION: Nearly one-third of women reporting premenstrual symptoms endorsed concurrent SI, a clinically valuable demonstration of the importance of this predictable cyclic risk factor.
RESUMO
BACKGROUND: Postpartum depression has a high prevalence in the United States (~13 %) and often goes undertreated/untreated. We conducted a multicenter, open-label, proof-of-concept trial to assess the Nesos wearable, non-invasive, transcutaneous auricular vagus nerve stimulation (taVNS) system for the treatment of major depressive disorder with peripartum onset (PPD). METHODS: Women (n = 25), ages 18 to 45, within 9 months postpartum, and diagnosed with PPD were enrolled at 3 sites. The study included 6 weeks open-label therapy and 2 weeks observation. Efficacy outcomes included change from baseline (CFB) in Hamilton Rating Scale for Depression (HAMD17) total scores, HAM-D17 response and remission, and patient and clinician global impression of change (PGIC, CGIC) scores. Analysis included descriptive statistics and mixed-effects models for repeated measures. RESULTS: The most common AEs (≥5 %) were discomfort (n = 5), headache (n = 3), and dizziness (n = 2); all resolved without intervention. No serious AEs or deaths occurred. Baseline mean HAM-D17 score was 18.4. Week 6 least squares (LS) mean CFB in HAM-D17 score was -9.7; 74 % achieved response and 61 % achieved remission. At week 6, at least some improvement was reported by 21 of 22 (95 %) clinicians on CGIC and 22 of 23 (96 %) participants on PGIC. LIMITATIONS: This was a single-arm, open-label study, and enrollment was limited to participants with mild-to-moderate peripartum depression. CONCLUSION: Results from this proof-of-concept study suggest that the Nesos taVNS system is well tolerated and may be an effective non-invasive, non-pharmacological treatment for major depressive disorder with peripartum onset. Further evaluation in larger sham-controlled studies is needed. CLINICALTRIALS: govNCT03972995.