Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression
NCT00521352 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 25
Last updated 2014-09-22
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.
Conditions
- Panic Disorder
- Major Depressive Disorder
Interventions
- DEVICE
-
Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Strong electromagnetic field (\~2Tesla) generated briefly (\~1ms) but repetitively (1Hz) for 30min, five sessions a week for up to eight weeks.
- DEVICE
-
Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
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.
Sponsors & Collaborators
-
New York State Psychiatric Institute
lead OTHER
Principal Investigators
-
Antonio Mantovani, MD · Columbia University
-
Sarah H Lisanby, MD · Columbia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2007-10-31
- Primary Completion
- 2011-06-30
- Completion
- 2011-06-30
Countries
- United States
Study Locations
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