Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-11-30

Study Completion Date

2017-01-31

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.

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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.

Conditions

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Major Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Active Transcranial Magnetic Stimulation

38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.

Group Type ACTIVE_COMPARATOR

Active Transcranial Magnetic Simulation

Intervention Type DEVICE

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.

Sham Transcranial Magnetic Stimulation

38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.

Group Type SHAM_COMPARATOR

Sham Transcranial Magnetic Stimulation

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Other Intervention Names

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Neuronetics 2100 CRS TMS System The eSham System

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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

39 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No