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rTMS Treatment in Patients With General Anxiety Disorder

Primary Purpose

Generalized Anxiety Disorder

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Repetitive transcranial magnetic stimulation
placebo sham
Sponsored by
Queen's University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Generalized Anxiety Disorder

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Military Medical Academy
  • Providence Care Mental Health Services

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

1

2

Arm Description

Outcomes

Primary Outcome Measures

Hamilton Anxiety Rating Scale (ham-a)

Secondary Outcome Measures

Clinical Global Impression
Hamilton Depression Rating Scale-21
Pittsburgh Sleep Quality Index
SF-36 QOL version (1)
Visual Analogue Scales

Full Information

First Posted
February 4, 2008
Last Updated
December 14, 2015
Sponsor
Queen's University
Collaborators
Military Medical Academy
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1. Study Identification

Unique Protocol Identification Number
NCT00616447
Brief Title
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

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
January 2008 (undefined)
Primary Completion Date
November 2012 (Actual)
Study Completion Date
November 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Queen's University
Collaborators
Military Medical Academy

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Title
2
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Repetitive transcranial magnetic stimulation
Other Intervention Name(s)
rTMS machine (MagPro, Medtronic).
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
placebo sham
Other Intervention Name(s)
rTMS machine (MagPro, Medtronic).
Intervention Description
Sham treatment will mimic active treatment mentioned above.
Primary Outcome Measure Information:
Title
Hamilton Anxiety Rating Scale (ham-a)
Time Frame
baseline, week 2, 4, 6, 8, 12
Secondary Outcome Measure Information:
Title
Clinical Global Impression
Time Frame
baseline, 2, 4, 6, 8, 12
Title
Hamilton Depression Rating Scale-21
Time Frame
baseline, week 2, 4, 6, 8, 12
Title
Pittsburgh Sleep Quality Index
Time Frame
baseline, week 2, 4, 6, 8, 12
Title
SF-36 QOL version (1)
Time Frame
baseline, week 2, 4, 6, 8, 12
Title
Visual Analogue Scales
Time Frame
baseline, week 2, 4, 6, 8, 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Roumen Milev, MD
Organizational Affiliation
Queen's University
Official's Role
Study Chair
Facility Information:
Facility Name
Military Medical Academy
City
Sofia
Country
Bulgaria
Facility Name
Providence Care Mental Health Services
City
Kingston
State/Province
Ontario
ZIP/Postal Code
K7L4X3
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
28533148
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.
Results Reference
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rTMS Treatment in Patients With General Anxiety Disorder

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