Premenstrual Dysphoric DisorderNCT02448836
Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
A study testing dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil in people with Premenstrual Dysphoric Disorder, run by Tel-Aviv Sourasky Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Premenstrual Dysphoric Disorder
- What is being tested?
- dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet.
About this study
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.
Read the detailed description
Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant distress in 5% of reproductive age women worldwide. The disorder was recently added to the diagnostic and statistical manual of mental disorders (DSM-5) as one of the mood disorders. PMDD is characterized by affective, cognitive, behavioral, and somatic symptoms. Treatment possibilities are limited, and 30-40% of patients who do not respond to antidepressants or oral contraceptives, are faced with no alternative effective treatment options. PMDD is highly comorbid with major depressive disorder (MDD) and neuroimaging studies in both disorders demonstrate dysfunction of the dorsolateral prefrontal cortex (DLPFC).
Deep transcranial magnetic stimulation (dTMS) is a technique of neuromodulation based on specific anatomic induction of an electric field in the brain. To date, dTMS was proved as an effective treatment tool in a number of mental conditions including drug-resistant major depression, in which the onset of the salutary effect of dTMS was relatively quick (compared with conventional antidepressants). Most clinical trials studying the effect of dTMS in major depression, focused on stimulating the DLPFC.
The investigators propose to conduct a prospective double blind cross-over study, to study the effect of short-term dTMS treatment on PMDD patients.
The aim of this study is to conduct the first evaluation of deep transcranial magnetic stimulation (dTMS) as a treatment option for premenstrual dysphoric disorder (PMDD). The treatment of this recurrent episodic disorder, that effects young, reproductive-age women, poses a significant clinical challenge, as current treatment options imply reproductive impairment (oral contraceptives or GnRH (gonadotropin-releasing hormone) agonists) or disturbing side effects (e.g. sexual side effects in SSRI's (selective serotonin reuptake inhibitor)).
In addition, as many as 40% of women with PMDD do not respond to conventional antidepressants or oral contraceptives, and remain without an effective and tolerable treatment option.
The symptoms of PMDD are episodic and time-limited, and indeed, some of the pharmacological treatment strategies for PMDD consist of intermittent therapy. Thus, he investigators assume that dTMS administered during the 7-14 symptomatic days (after ovulation), may provide a highly needed, tolerable and efficient treatment option for women suffering from this disorder, and may actually prevent the onset of symptoms.
- Conditions
- Premenstrual Dysphoric Disorder
- Being tested
- dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil, Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil
- Medical subject headings
- Premenstrual Dysphoric Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilDevice
Patients will undergo 8 sessions of dTMS treatment for two weeks (4 sessions every week).
Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilDevice
Patients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week).
| Study group | Role | What they receive |
|---|---|---|
| Active dTMS treatment | Experimental | In 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. Receives: Device: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil |
| Sham dTMS treatment | Sham comparator | In 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. Receives: Device: Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil |
What is being measured
The primary outcome is the main question the study is designed to answer.
PMDD symptoms as measured by the PMTS (Premenstrual Tension Syndrome) scales
Measured: 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
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2015 (estimated)
- Study startJun 2015
- Primary completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Premenstrual Dysphoric DisorderStudies of the same condition, open and under way.
- More trials run by Tel-Aviv Sourasky Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tel-Aviv Sourasky Medical Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Oren Tene, M.D, Principal investigator, TASMC Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02448836
- Sponsor's protocol ID
- TASMC-15-OT-0034-CTIL
- Status last verified
- May 2015
- First submitted
- 3 May 2015
- Last updated
- 20 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lerner Y, Krasnoshtein M, Bloch M, Tevet M, Doron M, Gonen T, Hendler T, Tene O. Motivational neurobehavioral abnormalities under a naturalistic goal-conflict task in patients with premenstrual dysphoric disorder. Front Psychiatry. 2026 Jun 8;17:1776826. doi: 10.3389/fpsyt.2026.1776826. eCollection 2026.
PubMed 42338742
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
- ClinicalTrials.gov ID
- NCT02448836
- Acronym / sponsor ID
- TASMC-15-OT-0034-CTIL
- Conditions
- Premenstrual Dysphoric Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Tel-Aviv Sourasky Medical CenterOther government
- Study start
- Jun 2015
- Primary completion
- Dec 2016 (estimated)
- First posted
- 20 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Premenstrual dysphoric disorder (PMDD) is a hormone-dependent mental condition that causes significant distress in 5% of reproductive age women worldwide. The disorder was recently added to the diagnostic and statistical manual of mental disorders (DSM-5) as one of the mood disorders. PMDD is characterized by affective, cognitive, behavioral, and somatic symptoms. Treatment possibilities are limited, and 30-40% of patients who do not respond to antidepressants or oral contraceptives, are faced with no alternative effective treatment options. PMDD is highly comorbid with major depressive disorder (MDD) and neuroimaging studies in both disorders demonstrate dysfunction of the dorsolateral prefrontal cortex (DLPFC).
Deep transcranial magnetic stimulation (dTMS) is a technique of neuromodulation based on specific anatomic induction of an electric field in the brain. To date, dTMS was proved as an effective treatment tool in a number of mental conditions including drug-resistant major depression, in which the onset of the salutary effect of dTMS was relatively quick (compared with conventional antidepressants). Most clinical trials studying the effect of dTMS in major depression, focused on stimulating the DLPFC.
The investigators propose to conduct a prospective double blind cross-over study, to study the effect of short-term dTMS treatment on PMDD patients.
The aim of this study is to conduct the first evaluation of deep transcranial magnetic stimulation (dTMS) as a treatment option for premenstrual dysphoric disorder (PMDD). The treatment of this recurrent episodic disorder, that effects young, reproductive-age women, poses a significant clinical challenge, as current treatment options imply reproductive impairment (oral contraceptives or GnRH (gonadotropin-releasing hormone) agonists) or disturbing side effects (e.g. sexual side effects in SSRI's (selective serotonin reuptake inhibitor)).
In addition, as many as 40% of women with PMDD do not respond to conventional antidepressants or oral contraceptives, and remain without an effective and tolerable treatment option.
The symptoms of PMDD are episodic and time-limited, and indeed, some of the pharmacological treatment strategies for PMDD consist of intermittent therapy. Thus, he investigators assume that dTMS administered during the 7-14 symptomatic days (after ovulation), may provide a highly needed, tolerable and efficient treatment option for women suffering from this disorder, and may actually prevent the onset of symptoms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active dTMS treatment | Experimental | Device: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilIn 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 comparator | Device: Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilIn 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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilPatients will undergo 8 sessions of dTMS treatment for two weeks (4 sessions every week). | Device | Active dTMS treatment |
| Sham: dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coilPatients will undergo 8 sessions of Sham dTMS treatment for two weeks (4 sessions every week). | Device | Sham dTMS treatment |
Primary outcome
PMDD symptoms as measured by the PMTS (Premenstrual Tension Syndrome) scales
Time frame: 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
1 secondary outcome
PMDD symptoms as measured by DRSP (Daily Record of Severity of Problems) scale
Time frame: 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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2015.
- Derived from this study: PubMed 42338742Lerner Y, Krasnoshtein M, Bloch M, Tevet M, Doron M, Gonen T, Hendler T, Tene O. Motivational neurobehavioral abnormalities under a naturalistic goal-conflict task in patients with premenstrual dysphoric disorder. Front Psychiatry. 2026 Jun 8;17:1776826. doi: 10.3389/fpsyt.2026.1776826. eCollection 2026.
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Premenstrual Dysphoric Disorder ( PMDD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oren Tene, M.D principal investigator
TASMC Israel
Questions about this trial
What is this clinical trial studying?
A study testing dTMS H-coil system:magstim stimulator rapid2,BrainswayH1coil in people with Premenstrual Dysphoric Disorder, run by Tel-Aviv Sourasky Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 May 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oren Tene, M.D (972-3-6974693, orent@tlvmc.gov.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PMDD symptoms as measured by the PMTS (Premenstrual Tension Syndrome) scales (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02448836, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2015.