Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Major Depressive Disorder

Intervention / Treatment
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* Device: Active Transcranial Magnetic Simulation
* Device: Sham Transcranial Magnetic Stimulation


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 39 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active Transcranial Magnetic Stimulation<br>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<br>* 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.<br>* Other names: Neuronetics 2100 CRS TMS System;|
| Sham Comparator: Sham Transcranial Magnetic Stimulation<br>38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation. | Device: Sham Transcranial Magnetic Stimulation<br>* 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.<br>* Other names: The eSham System;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Major Depressive Disorder, Pregnancy, Brain Derived Neurotrophic Factor, Transcranial Magnetic Stimulation