Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

Generalized Anxiety Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01815099
• Other study ID #: DIEF003523.3
• Status: Recruiting
• Phase: N/A
• First received: September 4, 2012
• Last updated: May 13, 2014
• Start date: May 2014
• Est. completion date: May 2015

Study information

• Verified date: May 2014
• Source: Hartford Hospital
• Contact: Gretchen J Diefenbach, Ph.D.
• Phone: 860-545-7396
• Email: gretchen.diefenbach[@]hhchealth.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

Description:

Approximately five patients with GAD who failed to respond to a sham (placebo) TMS intervention will be enrolled. TMS sessions will occur twice a week for five weeks. Assessments will occur at pretreatment, weekly during treatment, and at posttreatment. Approximately five nonanxious control volunteers will also be recruited to complete pretreatment assessments for baseline comparison purposes.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: May 2015
• Est. primary completion date: May 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anxiety Disorders
• Generalized Anxiety Disorder

Intervention

Device:
• NeuroStar TMS
Treatment will entail twice weekly TMS sessions for 5 weeks.

Locations

Country	Name	City	State
United States	Hartford Hospital	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hartford Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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. Participants will be categorized for some analyses based upon treatment remission status defined as SIGH-A score.	Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session	No