Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation (TMS)
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|ClinicalTrials.gov Identifier: NCT01492309|
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder||Device: Active Transcranial Magnetic Simulation Device: Sham Transcranial Magnetic Stimulation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||22 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder|
|Study Start Date :||November 2011|
|Actual Primary Completion Date :||July 2016|
|Actual Study Completion Date :||January 2017|
Active Comparator: Active Transcranial Magnetic Stimulation
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
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.
Other Name: Neuronetics 2100 CRS TMS System
Sham Comparator: Sham Transcranial Magnetic Stimulation
38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
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.
Other Name: The eSham System
- Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment [ Time Frame: Change score from baseline to test day 20 (after 20 days of intervention) ]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 in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS) [ Time Frame: Change in concentration from test day 1 to test day 20 ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01492309
|United States, Pennsylvania|
|Penn Center for Women's Behavioral Wellness|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Cynthia N Epperson, M.D.||Penn Center for Women's Behavioral Wellness|