Transcranial Magnetic Stimulation (TMS) to Treat Premenstrual Dysphoric Disorder
Efficacy of Theta Burst Transcranial Magnetic Stimulation for the Treatment of Premenstrual Dysphoric Disorder – An Open Label Pilot Study
Monash University
30 participants
Nov 25, 2022
Interventional
Conditions
Summary
Premenstrual dysphoric disorder (PMDD) is a severe, cyclical depressive disorder that affects 2-8% of women of reproductive age. Previously known as late luteal phase dysphoric disorder, PMDD is characterised by irritability, mood changes/swings and physical symptoms of that develop during the luteal phase of the menstrual cycle and resolve after the commencement of menses. PMDD carries significant distress and morbidity, for which limited therapeutic options exist. The urgent and clear need exists for effective and harmless treatments in PMDD. The scope exists to investigate novel therapeutic modalities for this crippling disorder for many. The proposed project meets this need by investigating the efficacy of application of Theta Burst Stimulation (TBS) in PMDD in the form of a pilot study. Transcranial Magnetic Stimulation (TMS) is a non-invasive means of stimulating nerve cells in superficial areas of the brain. TBS (a patterned form of TMS) has been approved by the FDA as a treatment for treatment-resistant major depression. TBS has received minimal research attention as a potential treatment for PMDD. The research project aims to evaluate if theta burst stimulation (TBS) is effective in treating mood and other psychological symptoms in PMDD.
Eligibility
Inclusion Criteria7
- Meet the DSM-5 diagnostic criteria for Premenstrual Dysphoric Disorder (PMDD).
- 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
- Report of at least a one-year history of regularly experiencing PMDD symptoms.
- 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.
- No increase/initiation of new antidepressant(s) in the 4 weeks prior to enrolment.
- Demonstrated capacity to give informed consent.
Exclusion Criteria8
- Unable to provide informed consent.
- Currently pregnant.
- Experiencing an acute medical condition as assessed by the Study PI/Site PI.
- Assessed as living with a serious, comorbid mental illness(s) other than Major Depressive Disorder (MDD).
- Presenting with clinically-significant risk of suicide.
- Assessed as having a concomitant neurological disorder or a history of a seizure disorder.
- Assessed as having an active substance or alcohol use disorder.
- History of adverse effects to Repetitive Transcranial Magnetic stimulation (rTMS) of clinical significance.
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Interventions
Female participants, aged 18-45, will receive daily sessions of Theta-burst stimulation (TBS) applied over 5 continuous days in the luteal phase (10 +/- 2 days after ovulation) in the treatment phase (Month 3 of study). TMS will be administered at the Monash Alfred Psychiatry Research Centre (MAPrc) by trained research staff. Stimulation is applied to the left dorsolateral prefrontal cortex (DLPFC), located using standard methods adjusting for head size. Stimulation intensity will be at 120% of the individual’s calibrated resting motor threshold.
Locations(1)
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ACTRN12622000909729