None listed
Conditions
Brief summary
(S)-S-adenosylmethionine (SAMe) is a physiological co-substrate, involved in cellular metabolism. SAMe is available as an over-the-counter complimentary medicine with an emerging role in the treatment of depression. Pre-menstrual spectrum disorders, including pre-menstrual syndrome (PMS) and pre-menstrual dysphoric disorder (PMDD), are highly prevalent and often treatment elusive. This study proposes a pilot open label clinical trial of SAMe in women with PMS/PMDD. 30 women will be recruited between the ages of 18-45 years old who experience regular menstrual cycles. Participants must have a diagnosis of a PMS or PMDD, or meet the criteria for diagnosis as determined at recruitment. Data will be collected over a 16-week period, involving the completion of questionnaires, including at baseline, and on day one of menstruation for a total of four menstrual cycles, alongside a daily pre-menstrual symptom questionnaire. Participants will receive SAMe 1200mg oral / day (400mg tablet taken three times per day) for 14-days prior to menstruation for two consecutive menstrual cycles. It is expected that SAMe will reduce pre-menstrual symptoms, and reduce symptoms of depression, anxiety and stress in treatment cycles compared to control cycles (no SAMe treatment). This novel study may provide preliminary evidence to support a future placebo-controlled double blinded randomised control trial.
Interventions
The intervention is the complementary medicine (S)-S-adenosylmethionine disulfate tosylate (SAMe), as SAMe 400 Complex. This study will involve the use of 1200mg of oral SAMe, self-administered by participants as 400mg oral SAMe 400 Complex three times daily, during the luteal phase (the 14 days leading up to menstruation), in two consecutive menstrual cycles. The intervention will be self-administered by participants, with clear instructions, during two “treatment” menstrual cycles, with one co
The intervention is the complementary medicine (S)-S-adenosylmethionine disulfate tosylate (SAMe), as SAMe 400 Complex. This study will involve the use of 1200mg of oral SAMe, self-administered by participants as 400mg oral SAMe 400 Complex three times daily, during the luteal phase (the 14 days leading up to menstruation), in two consecutive menstrual cycles. The intervention will be self-administered by participants, with clear instructions, during two “treatment” menstrual cycles, with one control cycle (no SAMe administration) at the start of the study and one control cycle at the end of the study. Ovulation will be confirmed using a urine ovulation test, which will be completed by participants 21 days after their last menstrual period until returning a positive result, every menstrual cycle. As a safety precaution, participants will also complete a urine pregnancy test the day before commencing SAMe treatment on both treatment cycles, and only commence treatment if they return a negative result. SAMe is available over-the-counter in Australia. Participants will be mailed 82 tablets of 400mg oral SAMe with clear instructions for self-administration. Adherence will be confirmed using self-report measures in the structured adverse events questionnaire, during the study conclusion interview and through a tablet return system at the end of the trial. SAMe is a physiological co-substrate involved in various biochemical reactions such DNA modification, epigenetic methylation and cellular metabolism. There is a growing body of evidence demonstrating the efficacy of SAMe in the treatment of depression.
Sponsors
Alfred Health
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
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.
Exclusion criteria
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.
Outcome results
None listed