ACTRN12621001269820Not yet recruiting未知
(S)-S-adenosylmethionine (SAMe) in the treatment of pre-menstrual spectrum disorders in adult women: An open-label pilot study
Conditions
Trial Snapshot
- Phase
- 未知
- Status
- Not yet recruiting
- Sponsor
- Alfred Health
- Enrollment
- 30
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
- Allocation
- Non-randomised trial
- Primary Purpose
- Treatment
- Masking
- Open (masking not used)
Eligibility Criteria
- Ages
- 18 Years to 45 Years (—)
- Sex
- Female
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.
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