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Clinical Trials/ACTRN12622000909729
ACTRN12622000909729
Recruiting
未知

Efficacy of Theta Burst Transcranial Magnetic Stimulation for the Treatment of Premenstrual Dysphoric Disorder – An Open Label Pilot Study

Monash University0 sites30 target enrollmentJune 27, 2022

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.

Registry
who.int
Start Date
June 27, 2022
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

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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