rTMS Treatment in Patients With General Anxiety Disorder

Study Overview
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Brief Summary
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This study will compare the change detected by a standardized rating scale (Hamilton Anxiety Rating Scale) scores in the active treatment group as compared to sham (placebo) group after 6 weeks of rTMS treatments. It is hoped that 6 weeks of rTMS treatment will lead to improvement of core symptoms in patients with GAD.

Official Title
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A 12-week, Double-blind, Randomized, Placebo-controlled Multicentered Study Evaluating Efficacy and Safety of High-frequency Repetitive Transcranial Magnetic Stimulation (rTMS) Treatment in Patients With Generalized Anxiety Disorder (GAD)

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Device: Repetitive transcranial magnetic stimulation
* Device: placebo sham


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: signed patient informed consent; 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: current serious Axis I schizophrenia, bipolar I, MDD; 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: Repetitive transcranial magnetic stimulation<br>* 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.<br>* Other names: rTMS machine (MagPro, Medtronic).;|
| Sham Comparator: 2<br> | Device: placebo sham<br>* Sham treatment will mimic active treatment mentioned above.<br>* Other names: rTMS machine (MagPro, Medtronic).;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Anxiety Rating Scale (ham-a) |  | baseline, week 2, 4, 6, 8, 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression |  | baseline, 2, 4, 6, 8, 12 | 
| Hamilton Depression Rating Scale-21 |  | baseline, week 2, 4, 6, 8, 12 | 
| Pittsburgh Sleep Quality Index |  | baseline, week 2, 4, 6, 8, 12 | 
| SF-36 QOL version (1) |  | baseline, week 2, 4, 6, 8, 12 | 
| Visual Analogue Scales |  | baseline, week 2, 4, 6, 8, 12 |