Beat the Blues in Pregnancy Study (TMS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by University of Pennsylvania
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Deborah Kim, University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01492309
First received: December 3, 2011
Last updated: June 6, 2014
Last verified: June 2014

December 3, 2011
June 6, 2014
November 2011
December 2016   (final data collection date for primary outcome measure)
Hamilton Rating Scale for Depression (HDRS-17) [ Time Frame: Test Day 1, 10 & 20 ] [ Designated as safety issue: No ]
We will be measuring changes in Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. The HDRS-17 will be administered on test day 1, 10, & 20.
Hamilton Rating Scale for Depression (HDRS-17) [ Time Frame: Test Day 1, 11 & 20 ] [ Designated as safety issue: No ]
We will be measuring changes in Hamilton Rating Scale for Depression (HDRS-17) scores from the beginning to end of treatment. The HDRS-17 will be administered on test day 1, 11, & 20.
Complete list of historical versions of study NCT01492309 on ClinicalTrials.gov Archive Site
Brain Derived Neurotrophic Factor Increase with Active Transcranial Magnetic Simulation (TMS) [ Time Frame: Test Day 1 & 20 ] [ Designated as safety issue: No ]
We will also be measuring levels of Brain Derived Neurotrophic Factor (BDNF), a protein thought to regulate mood and cognitive functioning. We will be obtaining BDNF values on test day 1 & 20. In addition, the relationship between BDNF and various hormones (estradiol, progesterone, allopregnanolone, oxytocin, and cortisol releasing hormone) will be examined.
Same as current
Not Provided
Not Provided
 
Beat the Blues in Pregnancy Study
Transcranial Magnetic Stimulation in Pregnant Women With Depressive Disorder

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Major Depressive Disorder
  • Device: Active Transcranial Magnetic Simulation
    Subjects will be given active TMS 5 days per week for 4 weeks for a total of 20 sessions. Each session will last approximately 10 minutes.
    Other Name: Neuronetics 2100 CRS TMS System
  • Device: Sham Transcranial Magnetic Stimulation
    Subjects will be given sham TMS 5 days per week for 4 weeks for a total of 20 sessions. The sham coil contains a shielding mechanism which diverts the magnetic field away from the patient. The sham treatment will last approximately 10 minutes.
    Other Name: The eSham System
  • Active Comparator: Active Transcranial Magnetic Stimulation
    38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.
    Intervention: Device: Active Transcranial Magnetic Simulation
  • Sham Comparator: Sham Transcranial Magnetic Stimulation
    38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
    Intervention: Device: Sham Transcranial Magnetic Stimulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
76
December 2016
December 2016   (final data collection date for primary outcome measure)

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).
Female
18 Years to 39 Years
No
Contact: Jessica L Snell, M.S. 215-573-8880 jessnell@mail.med.upenn.edu
Contact: Kathryn Czarkowski, M.A. 215-573-8882 kczar@mail.med.upenn.edu
United States
 
NCT01492309
812494, K23MH092399
Yes
Deborah Kim, University of Pennsylvania
University of Pennsylvania
National Institute of Mental Health (NIMH)
Principal Investigator: Deborah R Kim, M.D. Penn Center for Women's Behavioral Wellness
University of Pennsylvania
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP