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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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor);   Primary Purpose: Treatment
Condition Major Depressive Disorder
Interventions Device: Active Transcranial Magnetic Simulation
Device: Sham Transcranial Magnetic Stimulation
Enrollment 22
Recruitment Details  
Pre-assignment Details 22 participants were eligible at screening to be enrolled into the treatment arm of the study.
Arm/Group Title Active TMS Sham TMS
Hide Arm/Group Description 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Period Title: Overall Study
Started 11 11
Completed 11 11
Not Completed 0 0
Arm/Group Title Active TMS Sham TMS Total
Hide Arm/Group Description 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD Total of all reporting groups
Overall Number of Baseline Participants 11 11 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 11 participants 11 participants 22 participants
30.13  (5.78) 26.41  (5.11) 28.27  (5.65)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 11 participants 11 participants 22 participants
Female 11 11 22
Male 0 0 0
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 11 participants 11 participants 22 participants
11 11 22
1.Primary Outcome
Title Change in Hamilton Rating Scale for Depression (HDRS-17) Scores Pre- and Post- Treatment
Hide 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)
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active TMS Sham TMS
Hide Arm/Group Description:
11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Overall Number of Participants Analyzed 11 11
Mean (Standard Deviation)
Unit of Measure: difference in units on a scale
-13.909  (5.224) -9.091  (7.582)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TMS, Sham TMS
Comments This analysis is based on a mixed model that can handle missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.003
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
2.Secondary Outcome
Title Change in Brain Derived Neurotrophic Factor (BDNF) With Active Transcranial Magnetic Simulation (TMS)
Hide 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
Hide Outcome Measure Data
Hide Analysis Population Description
Only 4 participants from both the active and sham TMS groups were used in analysis because these participants had BDNF data at both time points. Furthermore, some samples were deemed unusable.
Arm/Group Title Active TMS Sham TMS
Hide Arm/Group Description:
11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Overall Number of Participants Analyzed 4 4
Mean (Standard Deviation)
Unit of Measure: pg/mL
146.8775  (235.6441) 40.0550  (131.9466)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Active TMS, Sham TMS
Comments This analysis is based on a mixed model that can handle missing data.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.425
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active TMS Sham TMS
Hide Arm/Group Description 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
All-Cause Mortality
Active TMS Sham TMS
Affected / at Risk (%) Affected / at Risk (%)
Total   0/11 (0.00%)      0/11 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Active TMS Sham TMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/11 (27.27%)      0/11 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
Preterm Birth  [1]  3/11 (27.27%)  3 0/11 (0.00%)  0
Indicates events were collected by systematic assessment
[1]
Late preterm birth
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active TMS Sham TMS
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/11 (36.36%)      1/11 (9.09%)    
Nervous system disorders     
Headaches   4/11 (36.36%)  17 1/11 (9.09%)  1
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Deborah Kim, MD
Organization: UPenn
Phone: 6107261020
Responsible Party: University of Pennsylvania
ClinicalTrials.gov Identifier: NCT01492309     History of Changes
Other Study ID Numbers: 812494
K23MH092399 ( U.S. NIH Grant/Contract )
First Submitted: December 3, 2011
First Posted: December 14, 2011
Results First Submitted: September 21, 2017
Results First Posted: April 10, 2018
Last Update Posted: April 10, 2018