Status:
COMPLETED
Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
National Institute of Mental Health (NIMH)
Conditions:
Major Depressive Disorder
Eligibility:
FEMALE
18-39 years
Phase:
NA
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 ...
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 grea...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2017
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT01492309
Start Date
November 1 2011
End Date
January 1 2017
Last Update
April 10 2018
Active Locations (1)
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1
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104