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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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
22 participants were eligible at screening to be enrolled into the treatment arm of the study.

Reporting Groups
  Description
Active TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Sham TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD

Participant Flow:   Overall Study
    Active TMS   Sham TMS
STARTED   11   11 
COMPLETED   11   11 
NOT COMPLETED   0   0 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Active TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Sham TMS 11 pregnant women in their 2nd or 3rd trimester with a primary diagnosis of MDD
Total Total of all reporting groups

Baseline Measures
   Active TMS   Sham TMS   Total 
Overall Participants Analyzed 
[Units: Participants]
 11   11   22 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.13  (5.78)   26.41  (5.11)   28.27  (5.65) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female   11   11   22 
Male   0   0   0 
Region of Enrollment 
[Units: Participants]
     
United States   11   11   22 


  Outcome Measures

1.  Primary:   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) ]

2.  Secondary:   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 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information

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
e-mail: drkim@upenn.edu


Publications:

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