rTMS Treatment in Patients With General Anxiety Disorder

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2012 by Queen's University.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Military Medical Academy
Information provided by (Responsible Party):
Roumen Milev, Queen's University
ClinicalTrials.gov Identifier:
NCT00616447
First received: February 4, 2008
Last updated: March 15, 2012
Last verified: March 2012
  Purpose

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.


Condition Intervention
Generalized Anxiety Disorder
Device: Repetitive transcranial magnetic stimulation
Device: placebo sham

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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)

Resource links provided by NLM:


Further study details as provided by Queen's University:

Primary Outcome Measures:
  • Hamilton Anxiety Rating Scale (ham-a) [ Time Frame: baseline, week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical Global Impression [ Time Frame: baseline, 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Hamilton Depression Rating Scale-21 [ Time Frame: baseline, week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Pittsburgh Sleep Quality Index [ Time Frame: baseline, week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • SF-36 QOL version (1) [ Time Frame: baseline, week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]
  • Visual Analogue Scales [ Time Frame: baseline, week 2, 4, 6, 8, 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: January 2008
Estimated Study Completion Date: November 2012
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: rTMS machine (MagPro, Medtronic).
Sham Comparator: 2 Device: placebo sham
Sham treatment will mimic active treatment mentioned above.
Other Name: rTMS machine (MagPro, Medtronic).

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00616447

Locations
Bulgaria
Military Medical Academy
Sofia, Bulgaria
Canada, Ontario
Providence Care Mental Health Services
Kingston, Ontario, Canada, K7L4X3
Sponsors and Collaborators
Queen's University
Military Medical Academy
Investigators
Study Chair: Roumen Milev, MD Queen's University
  More Information

No publications provided

Responsible Party: Roumen Milev, Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University, Queen's University
ClinicalTrials.gov Identifier: NCT00616447     History of Changes
Other Study ID Numbers: PSIY-270-07
Study First Received: February 4, 2008
Last Updated: March 15, 2012
Health Authority: Canada: Health Canada
Bulgaria: Bulgarian Drug Agency

Additional relevant MeSH terms:
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 22, 2014