Ignite Creation Date:
2024-05-05 @ 6:39 PM
Last Modification Date:
2024-10-26 @ 9:35 AM
Study NCT ID:
NCT00521352
Status:
COMPLETED
Last Update Posted:
2014-09-22
First Post:
2007-08-23
Brief Title:
Repetitive Transcranial Magnetic Stimulation rTMS in the Treatment of Panic Disorder With Comorbid Major Depression
Sponsor:
New York State Psychiatric Institute
Organization:
New York State Psychiatric Institute
Study Overview
Official Title:
Repetitive Transcranial Magnetic Stimulation rTMS in the Treatment of Panic Disorder PD With Comorbid Major Depression
Status:
COMPLETED
Status Verified Date:
2013-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
rTMS
Brief Summary:
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
1 compared to sham placebo active rTMS will improve symptoms of PD and MDD as assessed with the Panic Disorder Severity Scale PDSS Hamilton Depression Rating Scale HDRS and Clinical Global Impression CGI
2 active but not sham rTMS will normalize levels of motor cortex excitability relative to pre-treatment baseline
The investigators hypothesize that
1 compared to sham placebo active rTMS will improve symptoms of PD and MDD as assessed with the Panic Disorder Severity Scale PDSS Hamilton Depression Rating Scale HDRS and Clinical Global Impression CGI
2 active but not sham rTMS will normalize levels of motor cortex excitability relative to pre-treatment baseline
Detailed Description:
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 eg 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 ie 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
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 eg 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None