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NCT00521352 · ClinicalTrials.gov registry record · Phase 2
Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression
A Phase 2 study of Major Depressive Disorder and Panic Disorder, sponsored by New York State Psychiatric Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 1
- Study location
NCT00521352: Completed Phase 2 study of Major Depressive Disorder and Panic Disorder, sponsored by New York State Psychiatric Institute.
NCT00521352 is a Phase 2 study of Major Depressive Disorder and Panic Disorder that has completed, run by New York State Psychiatric Institute. The registered enrollment target is 25 participants, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (93% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00521352, a Phase 2 study of Major Depressive Disorder and Panic Disorder, has completed, sponsored by New York State Psychiatric Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
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
Conditions Studied
Interventions
- DEVICE Sham Repetitive Transcranial Magnetic Stimulation (rTMS)
- DEVICE Active Repetitive Transcranial Magnetic Stimulation (rTMS)
Study Locations (1)
New York
- New York State Psychiatric Institute - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2007-10 |
| Est. Completion | 2011-06 |
| Phase | Phase 2 |
What the finished NCT00521352 record still lists
NCT00521352 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 377-participant average among 282 other Major Depressive Disorder trials with a reported enrollment target (93% lower).
The record links to 2 conditions, with Major Depressive Disorder appearing as the primary indexed condition, and to 2 interventions - of which Sham Repetitive Transcranial Magnetic Stimulation (rTMS) is the first listed.
NCT00521352 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT00521352 about?
NCT00521352 is a clinical study titled "Repetitive Transcranial Magnetic Stimulation (rTMS) in the Treatment of Panic Disorder With Comorbid Major Depression". 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 t...
What is the current status of trial NCT00521352?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2007-10. Estimated completion is 2011-06.
What conditions does trial NCT00521352 study?
This clinical trial studies the following conditions: Major Depressive Disorder, Panic Disorder.
What interventions are being tested in trial NCT00521352?
The interventions under investigation include: Sham Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE), Active Repetitive Transcranial Magnetic Stimulation (rTMS) (DEVICE).
Who is sponsoring clinical trial NCT00521352?
This trial is sponsored by New York State Psychiatric Institute, which has 364 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00521352 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT00521352's enrollment target sits among peer trials
25 233rd of 282 higher than 48 of 282 other Major Depressive Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Major Depressive Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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