Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Pennsylvania
- Enrollment
- 22
- Locations
- 2
- Primary Endpoint
- Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 39 Years (Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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).
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)(Change in concentration from test day 1 to test day 20)