Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Study Overview
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Brief Summary
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We are investigating the feasibility and efficacy of transcranial magnetic stimulation (TMS) for patients with GAD who were placebo nonresponders in DIEF003523.1.

Detailed Description
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We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.

Official Title
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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2

Conditions
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Generalized Anxiety Disorder

Intervention / Treatment
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* Device: rTMS Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participated in the study DIEF003523.1, received sham placebo TMS and achieved < 50% improvement in HARS at 3 month follow-up. Fluency in English Capacity to understand the nature of the study and willingness to sign informed consent form Exclusion Criteria: History of epilepsy or head trauma (LOC > 5 minutes) within the past 6 months Lifetime history of increased intracranial pressure, seizure disorder, stroke, brain tumor, multiple sclerosis, or brain surgery A review of patient medications by the study physician indicates an increased risk of seizure An active autoimmune, endocrine, viral, or vascular disorder affecting the brain; any unstable cardiac disease; hypertension; or severe renal or liver insufficiency Substance use disorder or PTSD within the past 6 months Lifetime bipolar disorder, obsessive-compulsive disorder (OCD), psychotic disorder, mental retardation, or pervasive developmental disorder Any psychotic features, including dementia or delirium Concurrent psychotherapy and unwillingness to discontinue Medication change within the past 4 weeks Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within the past 6 months Serious, unstable, or terminal medical condition or clinically judged too psychiatrically unstable to participate in the study Any contraindication for participation in MRI scan

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: rTMS Treatment<br>Clinical participants will receive rTMS | Device: rTMS Treatment<br>* Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)<br>* Other names: Neurostar;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. | The Hamilton Anxiety Rating Scale (HARS) is one of the most commonly used and extensively validated outcome measures for anxiety symptoms. The SIGH-A allows for a standardized administration of the HARS. The total score was used in this study. The total score ranges from 0 to 56 with higher scores indicative of more severe anxiety symptoms. | Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session |