Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

NCT01815099 | Terminated Results

• 1 other identifier: DIEF003523.3
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

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.

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

rTMS Treatment

EXPERIMENTAL

Clinical participants will receive rTMS

Device: rTMS Treatment

Interventions

rTMS Treatment DEVICE

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

Also known as: Neurostar

rTMS Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hartford Hospital: lead
• Neuronetics: collaborator

Study Sites (1)

Hartford Hospital

Hartford, Connecticut, 06106, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Results Point of Contact

• Title: Gretchen Diefenbach
• Organization: Hartford Hospital

gretchen.diefenbach@hhchealth.org

860-545-7685

Study Officials

• Gretchen J Diefenbach, Ph.D.

  Hartford Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 4, 2012
• First Posted: March 20, 2013
• Study Start: May 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: April 10, 2017
• Results First Posted: April 10, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)