rTMS Treatment in Patients With General Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00616447
• Other study ID #: PSIY-270-07
• Status: Completed
• Phase: N/A
• First received: February 4, 2008
• Last updated: December 14, 2015
• Start date: January 2008
• Est. completion date: November 2012

Study information

• Verified date: December 2015
• Source: Queen's University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health CanadaBulgaria: Bulgarian Drug Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

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.
• placebo sham
Sham treatment will mimic active treatment mentioned above.

Locations

Country	Name	City	State
Bulgaria	Military Medical Academy	Sofia
Canada	Providence Care Mental Health Services	Kingston	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Queen's University	Military Medical Academy

Countries where clinical trial is conducted

Bulgaria,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hamilton Anxiety Rating Scale (ham-a)		baseline, week 2, 4, 6, 8, 12	No
Secondary	Clinical Global Impression		baseline, 2, 4, 6, 8, 12	No
Secondary	Hamilton Depression Rating Scale-21		baseline, week 2, 4, 6, 8, 12	No
Secondary	Pittsburgh Sleep Quality Index		baseline, week 2, 4, 6, 8, 12	No
Secondary	SF-36 QOL version (1)		baseline, week 2, 4, 6, 8, 12	No
Secondary	Visual Analogue Scales		baseline, week 2, 4, 6, 8, 12	No