ACTRN12622000909729
Recruiting
未知
Efficacy of Theta Burst Transcranial Magnetic Stimulation for the Treatment of Premenstrual Dysphoric Disorder – An Open Label Pilot Study
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Monash University
- Enrollment
- 30
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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.
Outcomes
Primary Outcomes
Not specified
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