Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
1 other identifier
interventional
30
0 countries
N/A
Brief Summary
Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant suffering in 5% of women of reproductive age worldwide. The prominent symptoms are depressed mood, irritability, mood lability and anxiety. Treatment options for PMDD are limited, with 40% non-responders. Deep transcranial magnetic stimulation (dTMS) is a novel therapeutic technique, which is based on modulating neural activity by inducing an electric field in the brain. To date, dTMS was found to be an effective treatment for depression, which is highly comorbid with PMDD. The investigators propose to study the effect of dTMS on PMDD patients in a prospective treatment study.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 3, 2015
CompletedFirst Posted
Study publicly available on registry
May 20, 2015
CompletedStudy Start
First participant enrolled
June 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedMay 20, 2015
May 1, 2015
1.5 years
May 3, 2015
May 14, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
PMDD symptoms as measured by the PMTS (Premenstrual Tension Syndrome) scales
Patients will be psychiatrically evaluated to assess their mental state and treatment progress throughout the duration of treatments sessions and up to 2 weeks after, an avarage of 6 weeks
Secondary Outcomes (1)
PMDD symptoms as measured by DRSP (Daily Record of Severity of Problems) scale
Patients will be psychiatrically evaluated to assess their mental state and treatment progress throughout the duration of treatments sessions and up to 2 weeks after, an avarage of 6 weeks
Study Arms (2)
Active dTMS treatment
EXPERIMENTALIn each menstrual cycle, patients will undergo 8 sessions of dTMS active treatment for two weeks (4 sessions every week) with dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil. The post ovulation phase is the luteal and symptomatic phase of PMDD patients.
Sham dTMS treatment
SHAM COMPARATORIn each menstrual cycle, patients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week) with dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil. The post ovulation phase is the luteal and symptomatic phase of PMDD patients.
Interventions
Patients will undergo 8 sessions of dTMS treatment for two weeks (4 sessions every week).
Patients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week).
Eligibility Criteria
You may qualify if:
- Women at reproductive age (18-50) with a regular menstrual cycle who:
- Fulfill screening criteria of the premenstrual screening Tool (PSST) for PMDD (Steiner et al., 2003).
- Report of at least a one year history of regularly experiencing PMDD symptoms, and meet diagnostic criteria for PMDD according to DSM-5 criteria on a clinical psychiatric interview (American Psychiatric Association, 2013).
- Fulfill criteria for PMDD prospectively, using the daily record of severity of problems (DRSP) (Endicott et al., 2006) for at least two full menstrual cycles of daily symptom charting, by e-mail via a specific software for Internet questionnaires ("Qaultrics"). A cycle will be considered symptomatic if the luteal phase mean score will be 50% greater than the mean follicular phase score (Endicott et al. 2006).
- Women receiving oral contraceptives (OC) will be included if usage of OC commenced 3 months prior to their enrollment.
You may not qualify if:
- Current pregnancy or getting pregnant during the study.
- Moderate-severe polycystic ovary syndrome
- Usage of hormonal IUD (intrauterine device)
- Recent initiation (less than 3 months) of antidepressant pharmacological treatment.
- Meet axis I DSM-5 diagnosis for a current major depressive episode or a psychotic disorder at admission.
- Substance dependence or abuse other than nicotine in the 30 days prior to screening.
- A personal history of seizures or epilepsy, a history of seizures or epilepsy in first degree relatives and the presence of any known factor that can lower the seizure threshold.
- Previous head injury and the presence of metallic implants in the cephalic region treatment.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Oren Tene, M.D
TASMC Israel
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2015
First Posted
May 20, 2015
Study Start
June 1, 2015
Primary Completion
December 1, 2016
Last Updated
May 20, 2015
Record last verified: 2015-05