Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute
ClinicalTrials.gov Identifier:
NCT00521352
First received: August 23, 2007
Last updated: September 16, 2014
Last verified: November 2013
Results First Received: December 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Panic Disorder
Major Depressive Disorder
Interventions: Device: Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Device: Sham Repetitive Transcranial Magnetic Stimulation (rTMS)

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Patients were recruited between January 2008 and December 2010 from the Brain Behavior Clinic and the Anxiety Disorders Clinic of New York State Psychiatric Institute/Columbia University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No enrolled participant was excluded from the trial. Twenty-five patients were recruited.

Reporting Groups
  Description
Active

Active repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks.

Sham

Placebo repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain.


Participant Flow:   Overall Study
    Active     Sham  
STARTED     12     13  
COMPLETED     11     10  
NOT COMPLETED     1     3  



  Baseline Characteristics
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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

Active repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) (active) : Strong electromagnetic field (~2Tesla) generated briefly (~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks.

Sham

Placebo repetitive Transcranial Magnetic Stimulation

Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) : Generates a field with the same parameters as active rTMS (see active arm for parameters), however, the actual magnetic fields are blocked by an electromagnetic shield built into a sham coil. The field is impeded from stimulating the brain.

Total Total of all reporting groups

Baseline Measures
    Active     Sham     Total  
Number of Participants  
[units: participants]
  12     13     25  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     12     13     25  
>=65 years     0     0     0  
Age  
[units: years]
Mean ± Standard Deviation
  40.2  ± 10     39.8  ± 13.3     40  ± 11.6  
Gender  
[units: participants]
     
Female     8     5     13  
Male     4     8     12  
Region of Enrollment  
[units: participants]
     
United States     12     13     25  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Panic Disorder Severity Scale (PDSS)   [ Time Frame: 4 weeks ]

2.  Primary:   Hamilton Depression Rating Scale (HDRS), 28 Item Version   [ Time Frame: 4 weeks ]

3.  Secondary:   Clinical Improvement (CGI-S)   [ Time Frame: 4 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Antonio Mantovani
Organization: Columbia University Department of Psychiatry, City University of New York
phone: 212-650-5417
e-mail: AMantovani@med.cuny.edu


Publications of Results:

Other Publications:
Publications automatically indexed to this study:

Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00521352     History of Changes
Other Study ID Numbers: 5517
Study First Received: August 23, 2007
Results First Received: December 13, 2012
Last Updated: September 16, 2014
Health Authority: United States: Institutional Review Board