Clinical trial NCT00616447: rTMS Treatment in Patients With General Anxiety Disorder
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: Military Medical Academy, Bulgaria
First posted: 2008-02-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Hamilton Anxiety Rating Scale (ham-a)
timeFrame: baseline, week 2, 4, 6, 8, 12
Secondary outcomes:
measure: Clinical Global Impression
timeFrame: baseline, 2, 4, 6, 8, 12
measure: Hamilton Depression Rating Scale-21
timeFrame: baseline, week 2, 4, 6, 8, 12
measure: Pittsburgh Sleep Quality Index
timeFrame: baseline, week 2, 4, 6, 8, 12
measure: SF-36 QOL version (1)
timeFrame: baseline, week 2, 4, 6, 8, 12
measure: Visual Analogue Scales
timeFrame: baseline, week 2, 4, 6, 8, 12
Other outcomes:
Locations:
city: Sofia
country: Bulgaria
facility: Military Medical Academy
city: Kingston
country: Canada
facility: Providence Care Mental Health Services
state: Ontario
Study officials:
affiliation: Queen's University
name: Roumen Milev, MD
role: STUDY_CHAIR
References:
citation: 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.