Research Study: Vortioxetine for Perimenopausal and Postmenopausal Women

Research Study: Vortioxetine for Perimenopausal and Postmenopausal Women

By | 2015-08-25T15:21:52+00:00 August 14th, 2015|Menopausal Symptoms|0 Comments

The menopausal transition is a difficult time for many women.  There is an increased risk of depressive episodes during this transition in the reproductive lifecycle, and the majority of women will experience symptoms related to perimenopause (such as hot flashes, sleep disturbance, and cognitive complaints).

Vortioxetine (brand name Brintellix) is a novel antidepressant that was recently approved by the U.S. FDA for the treatment of major depressive disorder. Like many other commonly used antidepressants, vortioxetine modulates the serotonin (5-HT) neurotransmitter system and the serotonin transporter.  It is distinct, however, in that it interacts with many different serotonin receptor subtypes and affects levels of other neurotransmitters, including dopamine, norepinephrine, and acetylcholine.

Clinical studies have demonstrated that vortioxetine is efficacious for the treatment of major depressive disorder.  While we are lacking studies to compare the efficacy of vortioxetine to other antidepressants, vortioxetine may have certain characteristics that make it attractive to certain patients.  Interestingly, vortioxetine has been demonstrated to improve cognition in adults with major depressive disorder. Also, vortioxetine is being studied as a treatment for adult ADHD (www.clinicaltrials.org).

No previous clinical trials to date have focused specifically on the treatment of perimenopausal women. However, based on the clinical data available, it appears that vortioxetine may be an attractive option for this population.

Therefore, our research team is currently conducting a study to preliminarily assess whether vortioxetine appears effective for reducing depression that occurs during the menopause transition, and whether vortioxetine will improve other menopause-related symptoms, such as hot flashes, sleep disturbance, anxiety, and cognitive symptoms.

If you are a peri- or postmenopausal woman between the ages of 40 and 62, have experienced changes in your menstrual cycle, are feeling down or depressed, and are not currently taking antidepressants or hormone therapy, you may be eligible for the study. Women who participate will receive study medication and evaluation at no cost and will be compensated up to $225 over the course of the 8 week study.

Please contact Laura Cheng at ljcheng@partners.org or 617-724-6540 if you are interested or have any questions regarding this study.

Laura Cheng, BA

Al-Sukhni M, Maruschak NA, McIntyre RS. Vortioxetine: a review of efficacy, safety and tolerability with a focus on cognitive symptoms in major depressive disorder. Expert Opinion on Drug Safety. 2015 August 14. [Epub ahead of print]

Katona CL, Katona CP. New generation multi-modal antidepressants: focus on vortioxetine for major depressive disorder. Neuropsychiatric Disease and Treatment 2014; 10: 349-354

Sanchez C, Asin KE, Artigas F. Vortioxetine, a novel antidepressant with multimodal activity: Review of preclinical and clinical data. Pharmacology & Therapeutics 2015; 145: 43-57

Schatzberg AF, Blier P, Culpepper L, Jain R, Papakostas GI, Thase ME. An Overview of Vortioxetine. The Journal of Clinical Psychiatry 2014; 75(12): 1411-1418

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