rTMS Treatment in Patients With General Anxiety Disorder

Queen's University

Status: Completed

Conditions: Generalized Anxiety Disorder

Treatments: Device: placebo sham; Device: Repetitive transcranial magnetic stimulation

Study type: Interventional

Funder types: Other

Identifiers

NCT00616447

PSIY-270-07

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 2 patient groups

1

Experimental group

Treatment:

Device: Repetitive transcranial magnetic stimulation

2

Sham Comparator group

Treatment:

Device: placebo sham