NCT01492309

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22

participants targeted

Target at below P25 for not_applicable major-depressive-disorder

Timeline
Completed

Started Nov 2011

Longer than P75 for not_applicable major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2011

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 3, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 14, 2011

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 10, 2018

Completed
Last Updated

April 10, 2018

Status Verified

March 1, 2018

Enrollment Period

4.7 years

First QC Date

December 3, 2011

Results QC Date

September 21, 2017

Last Update Submit

March 14, 2018

Conditions

Major Depressive Disorder

Keywords

Major Depressive DisorderPregnancyBrain Derived Neurotrophic FactorTranscranial Magnetic Stimulation

Outcome Measures

Primary Outcomes (1)

  • 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.

    Change score from baseline to test day 20 (after 20 days of intervention)

Secondary Outcomes (1)

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

    Change in concentration from test day 1 to test day 20

Study Arms (2)

Active Transcranial Magnetic Stimulation

ACTIVE COMPARATOR

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

Sham Transcranial Magnetic Stimulation

SHAM COMPARATOR

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

Device: Sham Transcranial Magnetic Stimulation

Interventions

Active Transcranial Magnetic SimulationDEVICE

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.

Also known as: Neuronetics 2100 CRS TMS System
Active Transcranial Magnetic Stimulation
Sham Transcranial Magnetic StimulationDEVICE

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.

Also known as: The eSham System
Sham Transcranial Magnetic Stimulation

Eligibility Criteria

Age18 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn Center for Women's Behavioral Wellness

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (5)

  • 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.

    PMID: 21314450BACKGROUND

  • 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.

    PMID: 19909665BACKGROUND

  • 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.

    PMID: 21572235BACKGROUND

  • 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.

    PMID: 20424977BACKGROUND

  • 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.

    PMID: 20597620BACKGROUND

Related Links

MeSH Terms

Conditions

Depressive Disorder, Major

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental Disorders

Results Point of Contact

Title
Deborah Kim, MD
Organization
UPenn
drkim@upenn.edu
6107261020

Study Officials

  • Cynthia N Epperson, M.D.

    Penn Center for Women's Behavioral Wellness

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 3, 2011

First Posted

December 14, 2011

Study Start

November 1, 2011

Primary Completion

July 1, 2016

Study Completion

January 1, 2017

Last Updated

April 10, 2018

Results First Posted

April 10, 2018

Record last verified: 2018-03

Locations

US(1)