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

Not Applicable

• Conditions: Premenstrual Dysphoric Disorder; Premenstrual Syndrome; Mental Health - Other mental health disorders; Reproductive Health and Childbirth - Menstruation and menopause

• Registration Number: ACTRN12621001269820
• Lead Sponsor: Alfred Health

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-09-20
• Last Update Posted: 27 September 2021

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: Female
• Target Recruitment: 30

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in overall severity of premenstrual spectrum disorder symptoms as measured by the mean Daily Record of Severity of Problems (DRSP) questionnaire score in the luteal phase of the SAMe treatment cycles (treatment cycle one and two) compared to untreated cycles (baseline and washout). [The primary outcome measure will be the mean DRSP total score over 14-days during the luteal phase of the menstrual cycle. This will include the sum of the 21 items including items assessing mood and physical symptoms, alongside social impacts of these symptoms. <br><br>The Daily Record of Severity of Problems (DRSP) will be recorded daily, and the mean DRSP across the 14 day luteal phase of each treatment cycle will be compared to the mean score across the 14 day luteal phase of the control menstrual cycles (baseline and washout cycles). ]

Secondary Outcome Measures

Name	Time	Method
Change in severity of depression and anxiety symptoms of Pre-Menstrual Spectrum Disorders as measured by the 21-item Depression Anxiety Stress Scale (DASS-21) in the luteal phase of the SAMe treatment cycles (treatment cycle one and two) compared to untreated cycles (baseline and washout). This will be assessed as a composite outcome. [The DASS-21 will be measured on the first day of menstruation during each treatment (treatment cycle one and two) and control menstrual cycle (baseline and washout cycle). ]