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Sponsored by: |
New York State Psychiatric Institute |
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Information provided by: | New York State Psychiatric Institute |
ClinicalTrials.gov Identifier: | NCT00521352 |
This study will evaluate the efficacy of 1-Hz rTMS applied to the right Dorsolateral Prefrontal Cortex (DLPFC) in patients with Panic Disorder (PD) and comorbid Major Depressive Disorder (MDD) who have not fully responded to conventional therapies.
The investigators hypothesize that:
Condition | Intervention | Phase |
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Panic Disorder Major Depressive Disorder |
Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (active) Device: Repetitive Transcranial Magnetic Stimulation (rTMS) (sham) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder (PD) With Comorbid Major Depression |
Estimated Enrollment: | 20 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | October 2011 |
Estimated Primary Completion Date: | October 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Active: Active Comparator |
Device: 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.
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Sham: Sham Comparator |
Device: 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.
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This study tests the efficacy of repetitive Transcranial Magnetic Stimulation (rTMS) in the treatment of Panic Disorder (PD) with comorbid Major Depression (MDD).
Despite major advances in the treatment of PD, standard therapeutic interventions are not effective for all patients, and the most common reasons for treatment failure in PD are side effects and major depression comorbidity. rTMS is a non-invasive procedure that allows stimulation of the brain using magnetic fields. Some studies have reported that rTMS may be helpful in reducing panic and depressive symptoms. While promising, prior research has several limitations (e.g., relatively small sample sizes, relatively short durations of treatment, and lack of sham (placebo) comparison).
This study addresses the drawbacks of prior work, and will provide data that will be important in determining whether rTMS can be useful for PD patients with comorbid MDD and resistant to conventional therapies. In this trial, 20 adult outpatients with PD and comorbid MDD, that have been only partially responsive to conventional therapies, will be randomly assigned to one of two treatment groups (active low frequency (1 Hz) rTMS or sham-placebo) applied to the right Dorsolateral Prefrontal Cortex (DLPFC) daily for up to four weeks. If rTMS will be added onto ongoing pharmacotherapy, the doses must have been stable for 1 month prior to study entry. The right DLPFC was selected because it is one among several brain regions implicated in PD, and functional abnormalities in DLPFC have also been consistently replicated in MDD. Pilot work indicates that stimulation of right DLPFC with low frequency rTMS was beneficial in patients with PD and MDD. Low frequency rTMS has the added benefit of a better safety profile (i.e. low risk of seizure) compared to high frequency rTMS.
Rating scales for symptom change will be obtained at baseline, during the rTMS course, and at the end of 4 weeks of treatment. Patients who do not meet response criteria after four weeks of sham will be offered an open-label cross-over phase for an additional four weeks of daily active rTMS treatment while partial responders to either active or sham will be offered an open-label cross-over phase for an additional four weeks of daily active rTMS treatment. Patients who meet response criteria in either the randomized phase or the cross-over phase will continue routine clinical care under the supervision of their treating psychiatrist, and will be invited back for a repeat assessment at 1, 3 and 6 months to determine the persistence of benefit.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other exclusion criteria include those common to every TMS protocol:
Contact: Clinic Coordinator | 212-543-5767 | bbclinic@columbia.edu |
Contact: Antonio Mantovani, MD | 212-543-6081 | am2518@columbia.edu |
United States, New York | |
New York State Psychiatric Institute | Recruiting |
New York, New York, United States, 10032 | |
Contact: Clinic Coordinator 212-543-5767 bbclinic@columbia.edu | |
Contact: Antonio Mantovani, MD 212-543-6081 amantovani@hotmail.com | |
Principal Investigator: Antonio Mantovani, MD | |
Sub-Investigator: Sarah H Lisanby, MD | |
Sub-Investigator: Helen B Simpson, MD, PhD | |
Sub-Investigator: Alexandra Sporn, MD | |
Sub-Investigator: Peter Bulow, MD |
Principal Investigator: | Antonio Mantovani, MD | Columbia University |
Study Chair: | Sarah H Lisanby, MD | Columbia University |
Responsible Party: | New York State Psychiatric Institute ( Dr. Antonio Mantovani ) |
Study ID Numbers: | 5517 |
Study First Received: | August 23, 2007 |
Last Updated: | September 8, 2008 |
ClinicalTrials.gov Identifier: | NCT00521352 |
Health Authority: | United States: Institutional Review Board |
TMS Dorsolateral Prefrontal Cortex |
Panic Disorder Depression Anxiety Disorders Mental Disorders |
Mood Disorders Depressive Disorder, Major Depressive Disorder Behavioral Symptoms |
Pathologic Processes Disease |