(S)-S-adenosylmethionine (SAMe) in the treatment of pre-menstrual spectrum disorders in adult women: An open-label pilot study

Alfred Health0 个研究点目标入组 30 人开始时间: 2021年9月20日最近更新: 2021年9月27日

适应症

试验速览

暂无简介。

•1. Women aged between 18-45 with regular menstrual cycles (regular onset, duration and cycle).
•2. Fulfill the diagnostic criteria for a premenstrual spectrum disorder, either PMS or PMDD as per the Diagnostic and Statistical Manual Version Five (DSM-V) criteria as screened during recruitment.
•3. Proficient in both reading and writing in English.
•4. Stabilise in current psychotherapy, if applicable, for at least eight weeks prior to study commencement.

•1. Pregnant or lactating women.
•2. Women less than one-year post-partum.
•2. Women with irregular menstrual cycles, including perimenopausal and menopausal women and women diagnosed with polycystic ovarian syndrome.
•3. Taking hormone replacement therapy and hormonally based contraceptives, including the Combined Oral Contraceptive Pill (COCP), etonogestrel implant (Implanon), intrauterine levonogestral devices (Mirena), transdermal oestradiol patches or depot progesterone injections.
•4. Taking psychotropic medications such as serotonergic agents, monoamine oxidase inhibitors or other forms of antidepressants, including atypical antidepressants such as agomelatine.
•5. Clinically significant renal or hepatic impairment, haematological, oncological or cardiovascular disease.
•6. Consumption of alcohol beyond the National Health and Medical Research Council (NHMRC) guidelines for safer alcohol use. That is, no more than 10 standard drinks a week and no more than four standard drinks in any single occasion.
•7. Substance misuse or dependence requiring intervention or rehabilitation in the last three months.
•8. Woman taking other complimentary alternative medicines, including cannabinoid containing agents such as cannabidiol (CBD) products.

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