Trial Outcomes & Findings for Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression (NCT NCT00521352)
NCT ID: NCT00521352
Last Updated: 2014-09-22
Results Overview
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.
COMPLETED
PHASE2
25 participants
4 weeks
2014-09-22
Participant Flow
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.
No enrolled participant was excluded from the trial. Twenty-five patients were recruited.
Participant milestones
| Measure |
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.
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
13
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression
Baseline characteristics by cohort
| Measure |
Active
n=12 Participants
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
n=13 Participants
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
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
12 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
40.2 years
STANDARD_DEVIATION 10 • n=5 Participants
|
39.8 years
STANDARD_DEVIATION 13.3 • n=7 Participants
|
40 years
STANDARD_DEVIATION 11.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
13 participants
n=7 Participants
|
25 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 weeksThe 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.
Outcome measures
| Measure |
Active
n=12 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Panic Disorder Severity Scale (PDSS)
|
6 responders
|
1 responders
|
PRIMARY outcome
Timeframe: 4 weeksThe 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.
Outcome measures
| Measure |
Active
n=12 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Hamilton Depression Rating Scale (HDRS), 28 Item Version
|
3 responders
|
1 responders
|
SECONDARY outcome
Timeframe: 4 weeksMinimum 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
Outcome measures
| Measure |
Active
n=12 Participants
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
n=13 Participants
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.
|
|---|---|---|
|
Clinical Improvement (CGI-S)
|
6 responders (CGI-S = 1 or 2)
|
1 responders (CGI-S = 1 or 2)
|
Adverse Events
Active
Sham
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Antonio Mantovani
Columbia University Department of Psychiatry, City University of New York
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place