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Beat the Blues in Pregnancy Study (TMS)

This study has been completed.
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania
ClinicalTrials.gov Identifier:
NCT01492309
First received: December 3, 2011
Last updated: February 9, 2017
Last verified: January 2017
  Purpose

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.


Condition Intervention
Major Depressive Disorder Device: Active Transcranial Magnetic Simulation Device: Sham Transcranial Magnetic Stimulation

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Participant, Outcomes Assessor
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation in Pregnant Women With Depressive Disorder

Further study details as provided by University of Pennsylvania:

Primary Outcome Measures:
  • Hamilton Rating Scale for Depression (HDRS-17) [ Time Frame: Test Day 1, 10 & 20 ]
    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.


Secondary Outcome Measures:
  • Brain Derived Neurotrophic Factor Increase with Active Transcranial Magnetic Simulation (TMS) [ Time Frame: Test Day 1 & 20 ]
    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.


Enrollment: 57
Study Start Date: November 2011
Study Completion Date: January 2017
Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
Sham Comparator: Sham Transcranial Magnetic Stimulation
38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
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

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

Ages Eligible for Study:   18 Years to 39 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01492309

Locations
United States, Pennsylvania
Penn Center for Women's Behavioral Wellness
Philadelphia, Pennsylvania, United States, 19104
Sponsors and Collaborators
University of Pennsylvania
National Institute of Mental Health (NIMH)
Investigators
Principal Investigator: Deborah R Kim, M.D. Penn Center for Women's Behavioral Wellness
  More Information

Additional Information:
Publications:
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01492309     History of Changes
Other Study ID Numbers: 812494
K23MH092399 ( U.S. NIH Grant/Contract )
Study First Received: December 3, 2011
Last Updated: February 9, 2017

Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No

Keywords provided by University of Pennsylvania:
Major Depressive Disorder
Pregnancy
Brain Derived Neurotrophic Factor
Transcranial Magnetic Stimulation

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 21, 2017