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Completed

NCT Number: NCT00616447

rTMS Treatment in Patients With General Anxiety Disorder

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.

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Key information

Conditions

Generalized Anxiety Disorder Anxiety Disorders Mental Disorders

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Military Medical Academy, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

repetitive transcranial magnetic stimulation

Device

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).

Placebo sham

Device

Sham treatment will mimic active treatment mentioned above.

Other names: rTMS machine (MagPro, Medtronic).

Primary outcomes

  1. Hamilton Anxiety Rating Scale (ham-a)

    Time frame: baseline, week 2, 4, 6, 8, 12

Secondary outcomes

  1. Clinical Global Impression

    Time frame: baseline, 2, 4, 6, 8, 12

  2. Hamilton Depression Rating Scale-21

    Time frame: baseline, week 2, 4, 6, 8, 12

  3. Pittsburgh Sleep Quality Index

    Time frame: baseline, week 2, 4, 6, 8, 12

  4. SF-36 QOL version (1)

    Time frame: baseline, week 2, 4, 6, 8, 12

  5. Visual Analogue Scales

    Time frame: baseline, week 2, 4, 6, 8, 12

Sponsors and collaborators

Lead sponsor

Queen's University

Other

Collaborators

  • Military Medical Academy, Bulgaria

Registry information

Official study 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)

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Feb 15, 2008
Registry last updated
Dec 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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