Erika Comasco1, Helena Kopp Kallner1, Marie Bixo1, Angelica L Hirschberg1, Sara Nyback1, Haro de Grauw1, C Neill Epperson1, Inger Sundström-Poromaa1. 1. Department of Neuroscience, Science for Life Laboratory (Comasco), and Department of Women's and Children's Health, Uppsala University, Uppsala (Nyback, de Grauw, Sundström-Poromaa); Department of Clinical Sciences at Danderyd Hospital Karolinska Institutet, and Department of Obstetrics and Gynecology, Danderyd Hospital, Stockholm (Kopp Kallner); Department of Clinical Sciences, Umeå University, Umeå, Sweden (Bixo); Department of Women's and Children's Health, Karolinska Institutet, and Department of Gynecology and Reproductive Medicine, Karolinska University Hospital, Stockholm (Hirschberg); Department of Psychiatry, University of Colorado School of Medicine, Aurora (Epperson).
Abstract
OBJECTIVE:Premenstrual dysphoric disorder (PMDD) is a common mood disorder, characterized by distressing affective, behavioral, and somatic symptoms in the late luteal phase of the menstrual cycle. The authors investigated continuous treatment with a selective progesterone receptor modulator, ulipristal acetate (UPA), as a potential treatment for PMDD. METHODS: The authors conducted an investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial in which women with PMDD (N=95) were treated with either 5 mg/day of UPA or placebo during three 28-day treatment cycles. The primary outcome was the change in premenstrual total score on the Daily Record of Severity of Problems (DRSP) from baseline to end of treatment. DRSP scores were captured by daily ratings using a smartphone application and were analyzed with linear mixed models for repeated measures. RESULTS: The mean improvement in DRSP score after 3 months was 41% (SD=18) in the UPA group, compared with 22% (SD=27) in the placebo group (mean difference -18%; 95% CI=-29, -8). Treatment effects were also noted for the DRSP depressive symptom subscale (42% [SD=22] compared with 22% [SD=32]) and the DRSP anger/irritability subscale (47% [SD=21] compared with 23% [SD=35]), but not for the DRSP physical symptom subscale. Remission based on DRSP score was attained by 20 women in the UPA group (50.0%) and eight women in the placebo group (21.1%) (a statistically significant difference). CONCLUSIONS: If these results are replicated, UPA could be a useful treatment for PMDD, particularly for the psychological symptoms associated with the disorder.
RCT Entities:
OBJECTIVE:Premenstrual dysphoric disorder (PMDD) is a common mood disorder, characterized by distressing affective, behavioral, and somatic symptoms in the late luteal phase of the menstrual cycle. The authors investigated continuous treatment with a selective progesterone receptor modulator, ulipristal acetate (UPA), as a potential treatment for PMDD. METHODS: The authors conducted an investigator-initiated, multicenter, double-blind, randomized, parallel-group clinical trial in which women with PMDD (N=95) were treated with either 5 mg/day of UPA or placebo during three 28-day treatment cycles. The primary outcome was the change in premenstrual total score on the Daily Record of Severity of Problems (DRSP) from baseline to end of treatment. DRSP scores were captured by daily ratings using a smartphone application and were analyzed with linear mixed models for repeated measures. RESULTS: The mean improvement in DRSP score after 3 months was 41% (SD=18) in the UPA group, compared with 22% (SD=27) in the placebo group (mean difference -18%; 95% CI=-29, -8). Treatment effects were also noted for the DRSP depressive symptom subscale (42% [SD=22] compared with 22% [SD=32]) and the DRSP anger/irritability subscale (47% [SD=21] compared with 23% [SD=35]), but not for the DRSP physical symptom subscale. Remission based on DRSP score was attained by 20 women in the UPA group (50.0%) and eight women in the placebo group (21.1%) (a statistically significant difference). CONCLUSIONS: If these results are replicated, UPA could be a useful treatment for PMDD, particularly for the psychological symptoms associated with the disorder.
Authors: Erika Comasco; Inger Sundström Poromaa; Anna Wikman; Julia Sacher; Marie Bixo; Angelica L Hirschberg; Helena Kopp Kallner; C Neill Epperson Journal: BMC Womens Health Date: 2022-02-11 Impact factor: 2.809
Authors: Benicio N Frey; Olivia R Allega; Maha Eltayebani; Sabrina K Syan; Jeronimo Mendes-Ribeiro; Luciano Minuzzi Journal: BMC Womens Health Date: 2022-03-30 Impact factor: 2.809