Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation (TMS)

Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Device: Active Transcranial Magnetic Simulation; Device: Sham Transcranial Magnetic Stimulation

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Penn Center for Women's Behavioral Wellness

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 39 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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;
• No change in antidepressant medication at least two weeks prior to study entry if using an antidepressant.

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;
• Anti-psychotic, lithium, or anti-convulsant 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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 Names: Neuronetics 2100 CRS TMS System
Sham Comparator: Sham Transcranial Magnetic Stimulation; 38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.	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 Names: The eSham System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment	We measured changes in Hamilton Rating Scale for Depression (HDRS-17) scores from baseline to post-treatment. The HDRS-17 was administered on test days 1, 10, & 20. Scoring is based on the 17-item scale and scores of 0-7 is generally accepted to be within the normal range, indicating minimal to no depression; scores of 8-16 suggest mild depression, 17-23 moderate depression and scores over 24 are indicative of severe depression; the maximum score being 52 on the 17-point scale.	Change score from baseline to test day 20 (after 20 days of intervention)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)	We measured the levels of Brain Derived Neurotrophic Factor (BDNF) concentration across time. BDNF is a protein thought to regulate mood and cognitive functioning and research has suggested that levels may vary by severity of mood symptoms. We obtained BDNF values on test days 1 & 20.	Change in concentration from test day 1 to test day 20

Collaborators and Investigators

• Sponsor: University of Pennsylvania
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Cynthia N Epperson, M.D., Penn Center for Women's Behavioral Wellness

Publications and helpful links

General Publications

• Kim DR, Epperson N, Pare 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. doi: 10.1089/jwh.2010.2353.
• 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. doi: 10.1007/s11920-009-0067-0.
• 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. doi: 10.1007/s11920-010-0114-x.
• Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond). 2010 Jul;6(4):565-76. doi: 10.2217/whe.10.27.

Helpful Links

• Program Website

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Actual): July 1, 2016
• Study Completion (Actual): January 1, 2017

Study Registration Dates

• First Submitted: December 3, 2011
• First Submitted That Met QC Criteria: December 12, 2011
• First Posted (Estimate): December 14, 2011

Study Record Updates

• Last Update Posted (Actual): April 10, 2018
• Last Update Submitted That Met QC Criteria: March 14, 2018
• Last Verified: March 1, 2018

More Information

Terms related to this study

• Keywords: Pregnancy; Transcranial Magnetic Stimulation; Major Depressive Disorder; Brain Derived Neurotrophic Factor
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder; Depressive Disorder, Major
• Other Study ID Numbers: 812494; K23MH092399 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes