Generalized Anxiety Disorder
Conditions
Brief summary
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.
Interventions
DEVICERepetitive 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.
DEVICEplacebo sham
Sham treatment will mimic active treatment mentioned above.
Sponsors
Military Medical Academy, Bulgaria
Queen's University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hamilton Anxiety Rating Scale (ham-a) | baseline, week 2, 4, 6, 8, 12 |
Secondary
| Measure | 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 |
Countries
Bulgaria, Canada
Outcome results
None listed