Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

NCT ID: NCT01815099

Last Updated: 2017-04-10

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 4 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-05-31
• Study Completion Date: 2015-08-31

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.

Conditions

Generalized Anxiety Disorder

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

rTMS Treatment

Clinical participants will receive rTMS

Group Type: EXPERIMENTAL

rTMS Treatment

Intervention Type: DEVICE

Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)

Interventions

rTMS Treatment

Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)

Intervention Type: DEVICE

Other Intervention Names

Neurostar

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Neuronetics

OTHER

Sponsor Role: collaborator

Hartford Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gretchen J Diefenbach, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Hartford Hospital

Locations

Hartford Hospital

Hartford, Connecticut, United States

Countries

United States

Other Identifiers

DIEF003523.3

Identifier Type: -

Identifier Source: org_study_id