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Trial registered on ANZCTR


Registration number
ACTRN12622000909729
Ethics application status
Approved
Date submitted
31/05/2022
Date registered
27/06/2022
Date last updated
16/01/2024
Date data sharing statement initially provided
27/06/2022
Type of registration
Prospectively registered

Titles & IDs
Public title
Transcranial Magnetic Stimulation (TMS) to Treat Premenstrual Dysphoric Disorder
Scientific title
Efficacy of Theta Burst Transcranial Magnetic Stimulation for the Treatment of Premenstrual Dysphoric Disorder – An Open Label Pilot Study
Secondary ID [1] 307261 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Premenstrual Dysphoric Disorder 326514 0
Condition category
Condition code
Mental Health 323778 323778 0 0
Other mental health disorders
Reproductive Health and Childbirth 324011 324011 0 0
Menstruation and menopause

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
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.
Intervention code [1] 323697 0
Treatment: Devices
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 331537 0
Change in premenstrual dysphoric disorder symptoms assessed using the Daily Record of Severity of Problems (DRSP)
Timepoint [1] 331537 0
Assessed daily from 2 months prior to intervention commencement to 1 month post-intervention commencement
Secondary outcome [1] 410210 0
Change in mood assessed using the Depression Anxiety Stress Scales (DASS-21)
Timepoint [1] 410210 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Secondary outcome [2] 410211 0
Change in cognitive performance assessed using the Controlled Oral Word Association Test (COWAT) verbal fluency task.
Timepoint [2] 410211 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Secondary outcome [3] 411227 0
Change in cognitive performance assessed using the Stroop task.
Timepoint [3] 411227 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Secondary outcome [4] 411228 0
Change in cognitive performance assessed using the Rey Auditory Verbal Learning Test (RAVLT).
Timepoint [4] 411228 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Secondary outcome [5] 411229 0
Change in cognitive performance assessed using the Digit Span forwards and backwards tasks.
Timepoint [5] 411229 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Secondary outcome [6] 411230 0
Change in cognitive performance assessed using desk-mounted video-based eye tracking.
Timepoint [6] 411230 0
Pre-treatment phase (during the 2 months prior to intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)
Treatment phase (during the month post-intervention commencement): once during luteal phase (10 +/-2 days after ovulation) and once in follicular phase (7 +/- 2 days after menses)

Eligibility
Key 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.
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key 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
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/07/2022
Actual
25/11/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
2
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 22474 0
Monash Alfred Psychiatry Research Centre - Melbourne
Recruitment postcode(s) [1] 37707 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 311558 0
Other
Name [1] 311558 0
Monash Alfred Psychiatry Research Centre
Country [1] 311558 0
Australia
Primary sponsor type
University
Name
Monash University
Address
External Relations, Development and Alumni
Locked Bag 7
MONASH UNIVERSITY VIC 3800
Country
Australia
Secondary sponsor category [1] 312973 0
None
Name [1] 312973 0
None
Address [1] 312973 0
None
Country [1] 312973 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 311007 0
Alfred Human Research and Ethics Committee
Ethics committee address [1] 311007 0
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 311007 0
Australia
Date submitted for ethics approval [1] 311007 0
01/06/2022
Approval date [1] 311007 0
25/11/2022
Ethics approval number [1] 311007 0

Summary
Brief 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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 119674 0
Dr Leo Chen
Address 119674 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Melbourne VIC 3004
Country 119674 0
Australia
Phone 119674 0
+61 390766564
Fax 119674 0
Email 119674 0
leo.chen@monash.edu
Contact person for public queries
Name 119675 0
Dr Elizabeth Thomas
Address 119675 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Melbourne VIC 3004
Country 119675 0
Australia
Phone 119675 0
+61 3 9076 5172
Fax 119675 0
Email 119675 0
tms-trials@monash.edu
Contact person for scientific queries
Name 119676 0
Dr Leo Chen
Address 119676 0
Monash Alfred Psychiatry Research Centre
Level 4, 607 St Kilda Rd
Melbourne VIC 3004
Country 119676 0
Australia
Phone 119676 0
+61 3 9076 6564
Fax 119676 0
Email 119676 0
leo.chen@monash.edu

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.