N/A
N=22
Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Major Depressive Disorder
Bottom Line
View on ClinicalTrials.gov: NCT01492309 ↗Enrolled (actual)
22
Serious AEs
13.6%
Results posted
Apr 2018
Primary outcome: Primary: Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment — -13.909; -9.091 difference in units on a scale — p=0.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Transcranial Magnetic Simulation (Device); Sham Transcranial Magnetic Stimulation (Device)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Pennsylvania
- Primary completion
- Jul 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment |
-13.909; -9.091 | 0.003 sig |
| SECONDARY Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS) |
146.8775; 40.0550 | 0.425 |
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.
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).
Data sourced from ClinicalTrials.gov (NCT01492309). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.