Major Depressive Disorder Clinical Trial
— TMSOfficial title:
Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
Verified date | March 2018 |
Source | University of Pennsylvania |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 22 |
Est. completion date | January 2017 |
Est. primary completion date | July 2016 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 39 Years |
Eligibility |
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). |
Country | Name | City | State |
---|---|---|---|
United States | Penn Center for Women's Behavioral Wellness | Philadelphia | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pennsylvania | National Institute of Mental Health (NIMH) |
United States,
Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. — View Citation
Kim DR, Epperson N, Paré E, Gonzalez JM, Parry S, Thase ME, Cristancho P, Sammel MD, O'Reardon JP. An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. J Womens Health (Larchmt). 2011 Feb;20(2):255-61. doi: 10.1089/jwh.2010.2353. — View Citation
Kim DR, Gonzalez J, O'Reardon JP. Pregnancy and depression: exploring a new potential treatment option. Curr Psychiatry Rep. 2009 Dec;11(6):443-6. Review. — View Citation
Kim DR, O'Reardon JP, Epperson CN. Guidelines for the management of depression during pregnancy. Curr Psychiatry Rep. 2010 Aug;12(4):279-81. doi: 10.1007/s11920-010-0114-x. — View Citation
Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond). 2010 Jul;6(4):565-76. doi: 10.2217/whe.10.27. Review. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment | 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 score from baseline to test day 20 (after 20 days of intervention) | |
Secondary | Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS) | 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. | Change in concentration from test day 1 to test day 20 |
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