Clinical Trial: Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
Study Status: Not yet recruiting
Recruit Status: Unknown status
Study Type: Interventional
Official Title: Deep Transcranial Magnetic Stimulation (dTMS) for the Treatment of Premenstrual Dysphoric Disorder (PMDD)
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.
Detailed Summary:
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)
Sponsor: Tel-Aviv Sourasky Medical Center
Current 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 ]
Original Primary Outcome: Same as current
Current 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 ]
Original Secondary Outcome: Same as current
Information By: Tel-Aviv Sourasky Medical Center
Dates:
Date Received: May 3, 2015
Date Started: June 2015
Date Completion:
Last Updated: May 14, 2015
Last Verified: May 2015
