Beat the Blues in Pregnancy Study
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|
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.
|Endpoint classification||efficacy study|
|Intervention model||parallel assignment|
|Masking||double blind (subject, outcomes assessor)|
Hamilton Rating Scale for Depression (HDRS-17)
time frame: Test Day 1, 10 & 20
Brain Derived Neurotrophic Factor Increase with Active Transcranial Magnetic Simulation (TMS)
time frame: Test Day 1 & 20
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).
|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.|
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