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Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation (TMS)

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ClinicalTrials.gov Identifier: NCT01492309
Recruitment Status : Completed
First Posted : December 14, 2011
Results First Posted : April 10, 2018
Last Update Posted : April 10, 2018
Sponsor:
Collaborator:
National Institute of Mental Health (NIMH)
Information provided by (Responsible Party):
University of Pennsylvania

Tracking Information
First Submitted Date  ICMJE December 3, 2011
First Posted Date  ICMJE December 14, 2011
Results First Submitted Date  ICMJE September 21, 2017
Results First Posted Date  ICMJE April 10, 2018
Last Update Posted Date April 10, 2018
Study Start Date  ICMJE November 2011
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
Hamilton Rating Scale for Depression (HDRS-17) [ Time Frame: Test Day 1, 11 & 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, 11, & 20.
Change History Complete list of historical versions of study NCT01492309 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 14, 2018)
Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS) [ Time Frame: Change in concentration from test day 1 to test day 20 ]
We measured the levels of Brain Derived Neurotrophic Factor (BDNF) concentration across time. BDNF is a protein thought to regulate mood and cognitive functioning and research has suggested that levels may vary by severity of mood symptoms. We obtained BDNF values on test days 1 & 20.
Original Secondary Outcome Measures  ICMJE
 (submitted: December 12, 2011)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Official Title  ICMJE Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
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 Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Major Depressive Disorder
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 14, 2018)
22
Original Estimated Enrollment  ICMJE
 (submitted: December 12, 2011)
76
Actual Study Completion Date  ICMJE January 2017
Actual Primary Completion Date July 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 39 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01492309
Other Study ID Numbers  ICMJE 812494
K23MH092399 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of Pennsylvania
Study Sponsor  ICMJE University of Pennsylvania
Collaborators  ICMJE National Institute of Mental Health (NIMH)
Investigators  ICMJE
Principal Investigator: Cynthia N Epperson, M.D. Penn Center for Women's Behavioral Wellness
PRS Account University of Pennsylvania
Verification Date March 2018

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