rTMS Treatment in Patients With General Anxiety Disorder
NCT ID: NCT00616447
Last Updated: 2015-12-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
30 participants
INTERVENTIONAL
2008-01-31
2012-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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1
Repetitive transcranial magnetic stimulation
6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
2
placebo sham
Sham treatment will mimic active treatment mentioned above.
Interventions
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Repetitive transcranial magnetic stimulation
6 weeks of repetitive transcranial magnetic stimulation . Treatment comprises of stimulation with rTMS frequency 20Hz, intensity 110% of MT, 20 trains, 9 sec/train, 51 sec ITI applied over right dorsolateral prefrontal cortex by a figure eight shaped coil. Treatment will be given 5 times a week for 4 weeks, 3 times a week during Week 5 and 2 times a week during Week 6.
placebo sham
Sham treatment will mimic active treatment mentioned above.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* primary GAD diagnosis;
* HARS \>=15;
* male/female 18-65 years;
* without GAD pharmacotherapy at least last 2 weeks or if they are taking GAD medication it must be stable for at least 6 weeks prior to the start of the study and not be changed during the 6 weeks of the study treatment phase.
* Individual or group supportive psychotherapy may continue during the study but will not be allowed to start new psychotherapy during the 6 weeks of the study treatment phase.
Exclusion Criteria
* other primary Axis I in the opinion of investigator;
* HDRS \>=18;
* metallic implant in cranium except mouth;
* severe/unstable medical conditions;
* ect within last 3 months;
* history epilepsy;
* neurological disorder leading to increased intracranial pressure;
* severe cardiac disorder/intracardiac lines/pacemakers;
* current suicide risk.
18 Years
65 Years
ALL
No
Sponsors
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Military Medical Academy, Bulgaria
OTHER
Queen's University
OTHER
Responsible Party
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Dr. Roumen Milev
Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University
Principal Investigators
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Roumen Milev, MD
Role: STUDY_CHAIR
Queen's University
Locations
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Military Medical Academy
Sofia, , Bulgaria
Providence Care Mental Health Services
Kingston, Ontario, Canada
Countries
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References
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Dilkov D, Hawken ER, Kaludiev E, Milev R. Repetitive transcranial magnetic stimulation of the right dorsal lateral prefrontal cortex in the treatment of generalized anxiety disorder: A randomized, double-blind sham controlled clinical trial. Prog Neuropsychopharmacol Biol Psychiatry. 2017 Aug 1;78:61-65. doi: 10.1016/j.pnpbp.2017.05.018. Epub 2017 May 19.
Other Identifiers
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PSIY-270-07
Identifier Type: -
Identifier Source: org_study_id