Transcranial Magnetic Stimulation - Depression in Pregnancy (TMS)

The purpose of this study is to determine if repetitive transcranial magnetic stimulation (TMS) will alleviate symptoms of major depressive disorder (MDD) in pregnant women.

TMS uses electromagnetic impulses to encourage neurons in the brain to communicate more effectively with one another. Effective neuron communication is thought to lead to the lessening of depressive symptoms. In this study subjects require daily TMS treatment for approximately four weeks.

We hypothesize that there will be a decline in the Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. We expect that this decrease will be significantly greater in subjects receiving active transcranial magnetic stimulation (TMS) compared to those receiving placebo TMS. Treatment response will be defined as greater than 50% reduction in HDRS-17 score.

We also hypothesize that levels of Brain Derived Neurotrophic Factor (BDNF), a protein thought to regulate mood and cognitive functioning, will increase in subjects who respond to TMS treatment. We expect BDNF levels to increase by greater than or equal to 20% in those who respond to TMS. As previously stated, TMS response will be defined as a significant decrease (50% or greater) in the HDRS-17 from baseline to end of treatment.

• Device: Active Transcranial Magnetic Simulation
  Subjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.
  Other Name: Neuronetics 2100 CRS TMS System
• Device: Sham Transcranial Magnetic Stimulation
  Subjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.
  Other Name: The eSham System

• Active Comparator: Active Transcranial Magnetic Stimulation
  38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.
  Intervention: Device: Active Transcranial Magnetic Simulation
• Sham Comparator: Sham Transcranial Magnetic Stimulation
  38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
  Intervention: Device: Sham Transcranial Magnetic Stimulation

• Kim DR, Epperson N, Paré E, Gonzalez JM, Parry S, Thase ME, Cristancho P, Sammel MD, O'Reardon JP. An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. J Womens Health (Larchmt). 2011 Feb;20(2):255-61.
• Kim DR, Gonzalez J, O'Reardon JP. Pregnancy and depression: exploring a new potential treatment option. Curr Psychiatry Rep. 2009 Dec;11(6):443-6. Review.
• Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. No abstract available.
• Kim DR, O'Reardon JP, Epperson CN. Guidelines for the management of depression during pregnancy. Curr Psychiatry Rep. 2010 Aug;12(4):279-81.
• Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond Engl). 2010 Jul;6(4):565-76. Review.

Inclusion Criteria:

• Subjects are capable of giving written informed consent and complying with all study procedures;
• Female age 18-39 years old at date of enrollment;
• Pregnant, weeks 14-34;
• Current Depressive Symptoms.

Exclusion Criteria:

• Any alcohol or drug abuse/dependence over the 6 months prior to study entry;
• History of a seizure disorder in subject or first degree relative;
• Antidepressant or antipsychotic medications within 2 weeks of study enrollment;
• History of known brain lesions, or severe head trauma;
• Subjects with any metallic object implanted in the skull;
• Subjects with significant cardiac disease;
• Neurological or psychiatric disorders;
• Serious medical illnesses that may compromise patient safety or study conduct;
• Currently taking a drug with known potential for fetal toxicity;
• Previous pregnancy with an adverse fetal outcome;
• Current obstetrical complications;
• Actively suicidal;
• History of depression unresponsive to treatment with electroconvulsive therapy (ECT).