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

University of Pennsylvania

Status: Completed

Conditions: Major Depressive Disorder

Treatments: Device: Sham Transcranial Magnetic Stimulation; Device: Active Transcranial Magnetic Simulation

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT01492309

812494

K23MH092399 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: Female

Ages: 18 to 39 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 2 patient groups

Active Transcranial Magnetic Stimulation

Active Comparator group

Description:

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

Treatment:

Device: Active Transcranial Magnetic Simulation

Sham Transcranial Magnetic Stimulation

Sham Comparator group

Description:

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

Treatment:

Device: Sham Transcranial Magnetic Stimulation