rTMS Treatment in Patients With General Anxiety Disorder

Not Applicable

Completed

• Conditions: Generalized Anxiety Disorder
• Interventions: Device: Repetitive transcranial magnetic stimulation; Device: placebo sham

• Registration Number: NCT00616447
• Lead Sponsor: Queen's University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-01
• Study First Submitted: 2008-02-04
• Study First Submitted QC: 2008-02-04
• Study First Posted: 2008-02-15
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Repetitive transcranial magnetic stimulation	-
2	placebo sham	-

Primary Outcome Measures

Name	Time	Method
Hamilton Anxiety Rating Scale (ham-a)	baseline, week 2, 4, 6, 8, 12

Secondary Outcome Measures

Name	Time	Method
Clinical Global Impression	baseline, 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
Hamilton Depression Rating Scale-21	baseline, week 2, 4, 6, 8, 12

Trial Locations

Locations (2)

Military Medical Academy; 🇧🇬 Sofia, Bulgaria

Providence Care Mental Health Services; 🇨🇦 Kingston, Ontario, Canada