Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Not Applicable

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
rTMS Treatment	rTMS Treatment	Clinical participants will receive rTMS

Primary Outcome Measures

Name	Time	Method
Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment.	Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session	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.

Secondary Outcome Measures