rTMS Treatment in Patients With General Anxiety Disorder

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)

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.

Study Overview

• Status: Completed
• Conditions: Generalized Anxiety Disorder
• Intervention / Treatment: Device: Repetitive transcranial magnetic stimulation; Device: placebo sham

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Bulgaria
  • Sofia, Bulgaria
    • Military Medical Academy
• Canada
  • Ontario
    • Kingston, Ontario, Canada, K7L4X3
      • Providence Care Mental Health Services

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Device: 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.; Other Names: rTMS machine (MagPro, Medtronic).
Sham Comparator: 2	Device: placebo sham; Sham treatment will mimic active treatment mentioned above.; Other Names: rTMS machine (MagPro, Medtronic).

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome 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

Collaborators and Investigators

• Sponsor: Queen's University
• Collaborators: Military Medical Academy
• Investigators: Study Chair: Roumen Milev, MD, Queen's University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): November 1, 2012
• Study Completion (Actual): November 1, 2012

Study Registration Dates

• First Submitted: February 4, 2008
• First Submitted That Met QC Criteria: February 4, 2008
• First Posted (Estimate): February 15, 2008

Study Record Updates

• Last Update Posted (Estimate): December 16, 2015
• Last Update Submitted That Met QC Criteria: December 14, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Anxiety Disorders
• Other Study ID Numbers: PSIY-270-07