Clinical trial NCT01492309: Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Official title: Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder
Pregnancy
Brain Derived Neurotrophic Factor
Transcranial Magnetic Stimulation
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2011-12-14
Enrollment: 22
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 39
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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).

Primary outcomes:
measure: Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
timeFrame: Change score from baseline to test day 20 (after 20 days of intervention)
Secondary outcomes:
measure: Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
timeFrame: Change in concentration from test day 1 to test day 20
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: Penn Center for Women's Behavioral Wellness
state: Pennsylvania
Study officials:
affiliation: Penn Center for Women's Behavioral Wellness
name: Cynthia N Epperson, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kim DR, Epperson N, Pare 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.
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. doi: 10.1007/s11920-009-0067-0.
citation: Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. No abstract available.
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.
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.