Overview

This trial is active, not recruiting.

Condition major depressive disorder
Treatments active transcranial magnetic simulation, sham transcranial magnetic stimulation
Sponsor University of Pennsylvania
Collaborator National Institute of Mental Health (NIMH)
Start date November 2011
End date December 2016
Trial size 57 participants
Trial identifier NCT01492309, 812494, K23MH092399

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.
active transcranial magnetic simulation Neuronetics 2100 CRS TMS System
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 Comparator)
38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
sham transcranial magnetic stimulation The eSham System
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.

Primary Outcomes

Measure
Hamilton Rating Scale for Depression (HDRS-17)
time frame: Test Day 1, 10 & 20

Secondary Outcomes

Measure
Brain Derived Neurotrophic Factor Increase with Active Transcranial Magnetic Simulation (TMS)
time frame: Test Day 1 & 20

Eligibility Criteria

Female participants from 18 years up to 39 years old.

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).

Additional Information

Official title Transcranial Magnetic Stimulation in Pregnant Women With Depressive Disorder
Principal investigator Deborah R Kim, M.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2015.
Information provided to ClinicalTrials.gov by University of Pennsylvania.