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Trial record 71 of 179 for:    "Panic Disorder"

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

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ClinicalTrials.gov Identifier: NCT00521352
Recruitment Status : Completed
First Posted : August 27, 2007
Results First Posted : September 22, 2014
Last Update Posted : September 22, 2014
Sponsor:
Information provided by (Responsible Party):
New York State Psychiatric Institute

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, 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)
Enrollment 25
Recruitment Details 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 No enrolled participant was excluded from the trial. Twenty-five patients were recruited.
Arm/Group Title Active Sham
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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.

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.

Period Title: Overall Study
Started 12 13
Completed 11 10
Not Completed 1 3
Arm/Group Title Active Sham Total
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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.

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 of all reporting groups
Overall Number of Baseline Participants 12 13 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
12
 100.0%
13
 100.0%
25
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 12 participants 13 participants 25 participants
40.2  (10) 39.8  (13.3) 40  (11.6)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 12 participants 13 participants 25 participants
Female
8
  66.7%
5
  38.5%
13
  52.0%
Male
4
  33.3%
8
  61.5%
12
  48.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 12 participants 13 participants 25 participants
12 13 25
1.Primary Outcome
Title Panic Disorder Severity Scale (PDSS)
Hide Description

The Panic Disorder Severity Scale is a questionnaire developed for measuring the severity of panic disorder symptoms.

The PDSS consists of seven items, each rated on a 5-point scale, which ranges from 0 to 4. The items assess panic frequency, resulting distress, panic-focused anticipatory anxiety, phobic avoidance of situations and of physical sensations, impairment in occupational and social functioning. The overall assessment is made by a total score, which is calculated by summing the scores for all seven items. The total scores range from 0 to 28.

Higher scores indicate high levels of panic symptomatology. Reduction in score from baseline indicates clinical improvement of panic symptoms.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: responders
6 1
2.Primary Outcome
Title Hamilton Depression Rating Scale (HDRS), 28 Item Version
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The Hamilton Rating Scale for Depression (HRSD) is a multiple item questionnaire used to provide an indication of depression severity. The 28-, rather then 17- or 24-, item version was used to assess subjects in this protocol.

28-item minimum score = 0 28-item maximum score = 84

Higher scores indicate high levels of symptomatology. Reduction in score from baseline indicates clinical symptom improvement.

Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: responders
3 1
3.Secondary Outcome
Title Clinical Improvement (CGI-S)
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Minimum CGI-S score: 1 Maximum CGI-S score: 7

Higher scores indicate the presence of high symptom severity. Decrease in scores from baseline reflects clinical symptom improvement.

Patients will be classified as responders with a CGI-S = 1 or 2; and partial responders CGI-S = 3.

  1. = Normal, not at all ill
  2. = Borderline mentally ill
  3. = Mildly ill
  4. = Moderately ill
  5. = Markedly ill
  6. = Severely ill
  7. = Among the most extremely ill patients
Time Frame 4 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Active Sham
Hide Arm/Group Description:

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.

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.

Overall Number of Participants Analyzed 12 13
Measure Type: Number
Unit of Measure: responders (CGI-S = 1 or 2)
6 1
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Active Sham
Hide Arm/Group Description

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.

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.

All-Cause Mortality
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/12 (0.00%)   0/13 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Active Sham
Affected / at Risk (%) Affected / at Risk (%)
Total   0/0   0/0 
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
Publications of Results:
Responsible Party: New York State Psychiatric Institute
ClinicalTrials.gov Identifier: NCT00521352     History of Changes
Other Study ID Numbers: 5517
First Submitted: August 23, 2007
First Posted: August 27, 2007
Results First Submitted: December 13, 2012
Results First Posted: September 22, 2014
Last Update Posted: September 22, 2014