NCT00616447

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2008

Longer than P75 for not_applicable

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 4, 2008

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 15, 2008

Completed
4.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

December 16, 2015

Status Verified

December 1, 2015

Enrollment Period

4.8 years

First QC Date

February 4, 2008

Last Update Submit

December 14, 2015

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

  • Hamilton Anxiety Rating Scale (ham-a)

    baseline, week 2, 4, 6, 8, 12

Secondary Outcomes (5)

  • Clinical Global Impression

    baseline, 2, 4, 6, 8, 12

  • Hamilton Depression Rating Scale-21

    baseline, week 2, 4, 6, 8, 12

  • Pittsburgh Sleep Quality Index

    baseline, week 2, 4, 6, 8, 12

  • SF-36 QOL version (1)

    baseline, week 2, 4, 6, 8, 12

  • Visual Analogue Scales

    baseline, week 2, 4, 6, 8, 12

Study Arms (2)

1

EXPERIMENTAL
Device: Repetitive transcranial magnetic stimulation

2

SHAM COMPARATOR
Device: placebo sham

Interventions

Repetitive transcranial magnetic stimulationDEVICE

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.

Also known as: rTMS machine (MagPro, Medtronic).
1
placebo shamDEVICE

Sham treatment will mimic active treatment mentioned above.

Also known as: rTMS machine (MagPro, Medtronic).
2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Military Medical Academy

Sofia, Bulgaria

Location

Providence Care Mental Health Services

Kingston, Ontario, K7L4X3, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28533148DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field TherapyTherapeutics

Study Officials

  • Roumen Milev, MD

    Queen's University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Psychiatry and Psychology, Head, Department of Psychiatry Queen's University

Study Record Dates

First Submitted

February 4, 2008

First Posted

February 15, 2008

Study Start

January 1, 2008

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

December 16, 2015

Record last verified: 2015-12

Locations

CA(1)BU(1)