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rTMS Treatment in Patients With General Anxiety Disorder

This study is ongoing, but not recruiting participants.
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
History of Changes
  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:

MedlinePlus related topics: Anxiety
U.S. FDA Resources

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 May 22, 2013