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

Primary Purpose

Major Depressive Disorder

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Transcranial Magnetic Simulation
Sham Transcranial Magnetic Stimulation
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Major Depressive Disorder, Pregnancy, Brain Derived Neurotrophic Factor, Transcranial Magnetic Stimulation

Eligibility Criteria

18 Years - 39 Years (Adult)FemaleDoes not accept healthy volunteers

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).

Sites / Locations

  • Penn Center for Women's Behavioral Wellness

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Active Transcranial Magnetic Stimulation

Sham Transcranial Magnetic Stimulation

Arm Description

38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.

38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.

Outcomes

Primary Outcome Measures

Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
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 Outcome Measures

Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
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.

Full Information

First Posted
December 3, 2011
Last Updated
March 14, 2018
Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT01492309
Brief Title
Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation
Acronym
TMS
Official Title
Transcranial Magnetic Stimulation (TMS) in Pregnant Women With Depressive Disorder
Study Type
Interventional

2. Study Status

Record Verification Date
March 2018
Overall Recruitment Status
Completed
Study Start Date
November 2011 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder
Keywords
Major Depressive Disorder, Pregnancy, Brain Derived Neurotrophic Factor, Transcranial Magnetic Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active Transcranial Magnetic Stimulation
Arm Type
Active Comparator
Arm Description
38 pregnant women with MDD will be randomized to receive active 1 Hz right-sided dorsolateral prefrontal cortex (DLPFC) TMS.
Arm Title
Sham Transcranial Magnetic Stimulation
Arm Type
Sham Comparator
Arm Description
38 pregnant women with MDD will be randomized to receive sham transcranial magnetic stimulation.
Intervention Type
Device
Intervention Name(s)
Active Transcranial Magnetic Simulation
Other Intervention Name(s)
Neuronetics 2100 CRS TMS System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Transcranial Magnetic Stimulation
Other Intervention Name(s)
The eSham System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
Description
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.
Time Frame
Change score from baseline to test day 20 (after 20 days of intervention)
Secondary Outcome Measure Information:
Title
Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
Description
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.
Time Frame
Change in concentration from test day 1 to test day 20

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
39 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cynthia N Epperson, M.D.
Organizational Affiliation
Penn Center for Women's Behavioral Wellness
Official's Role
Principal Investigator
Facility Information:
Facility Name
Penn Center for Women's Behavioral Wellness
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21314450
Citation
Kim DR, Epperson N, Pare E, Gonzalez JM, Parry S, Thase ME, Cristancho P, Sammel MD, O'Reardon JP. An open label pilot study of transcranial magnetic stimulation for pregnant women with major depressive disorder. J Womens Health (Larchmt). 2011 Feb;20(2):255-61. doi: 10.1089/jwh.2010.2353.
Results Reference
background
PubMed Identifier
19909665
Citation
Kim DR, Gonzalez J, O'Reardon JP. Pregnancy and depression: exploring a new potential treatment option. Curr Psychiatry Rep. 2009 Dec;11(6):443-6. doi: 10.1007/s11920-009-0067-0.
Results Reference
background
PubMed Identifier
21572235
Citation
Kim D, O'Reardon JP. Editorial: the treatment of depression during pregnancy. Isr J Psychiatry Relat Sci. 2011;48(1):3-5. No abstract available.
Results Reference
background
PubMed Identifier
20424977
Citation
Kim DR, O'Reardon JP, Epperson CN. Guidelines for the management of depression during pregnancy. Curr Psychiatry Rep. 2010 Aug;12(4):279-81. doi: 10.1007/s11920-010-0114-x.
Results Reference
background
PubMed Identifier
20597620
Citation
Tjoa C, Pare E, Kim DR. Unipolar depression during pregnancy: nonpharmacologic treatment options. Womens Health (Lond). 2010 Jul;6(4):565-76. doi: 10.2217/whe.10.27.
Results Reference
background
Links:
URL
http://www.med.upenn.edu/womenswellness/
Description
Program Website

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Beat the Blues in Pregnancy Study - Transcranial Magnetic Stimulation

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