Transcranial Magnetic Stimulation (TMS) to Treat Premenstrual Dysphoric Disorder

Not Applicable

Recruiting

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

• Registration Number: ACTRN12622000909729
• Lead Sponsor: Monash University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-06-27
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1.Meet the DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD).
2.Confirmation of PMDD diagnosis using the Carolina Premenstrual Assessment Scoring System (C-PASS) within the past 6 months. This scoring system confirms a PMDD diagnosis using two or more months of daily symptom ratings with the Daily Record of Severity of Problems (DRSP) measurement tool.
Participants who have had a PMDD diagnosis confirmed with this assessment within the preceding 6 months do not need to repeat the pre-treatment phase of the study
3.Report of at least a one-year history of regularly experiencing PMDD symptoms.
4.Women taking the oral contraceptive pill (OCP) or using a hormonal intrauterine device (IUD) are required to have commenced the same OCP or IUD at least 3 months prior to their enrolment, while continuing to meet criteria 1 and 2 above at the time of study consent.
5.No increase/initiation of new antidepressant(s) in the 4 weeks prior to enrolment.
6.Demonstrated capacity to give informed consent.

Exclusion Criteria

1.Unable to provide informed consent.
2.Currently pregnant.
3.Experiencing an acute medical condition as assessed by the Study PI/Site PI.
4.Assessed as living with a serious, comorbid mental illness(s) other than Major Depressive Disorder (MDD).
5.Presenting with clinically-significant risk of suicide.
6.Assessed as having a concomitant neurological disorder or a history of a seizure disorder.
7.Assessed as having an active substance or alcohol use disorder.
8.History of adverse effects to Repetitive Transcranial Magnetic stimulation (rTMS) of clinical significance.

Study & Design

• Study Type: Interventional
• Study Design: Not specified