Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

NCT01659736 | Completed Results

• 1 other identifier: DIEF003523.1
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief Summary

This study is investigating a new indication of Transcranial Magnetic Stimulation (TMS) by conducting a pilot randomized-controlled trial (RCT) comparing structural neuronavigation-directed TMS to Sham-TMS Placebo therapy for treatment of Generalized Anxiety Disorder (GAD).

Conditions

Generalized Anxiety Disorder

Outcome Measures

Primary Outcomes (5)

• Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.

  Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.

  Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up

• Responder Status

  Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to post-treatment.

  Post-treatment, 6 weeks

• Remission Status

  Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at post-treatment.

  post-treatment, 6 weeks

• Responder Status

  Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Responder status was defined as a ≥ 50% improvement (i.e., reduction) in SIGH-A scores from pre-treatment to 3-month follow-up.

  3-month follow-up

• Remission Status

  Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety. Remission status was defined as a SIGH-A score \< 8 and Clinical Global Impression Improvement score = 1 ("very much improved") or 2 ("much improved") at 3-month follow-up.

  3-month follow-up

Study Arms (2)

TMS Therapy

EXPERIMENTAL

TMS treatment

Device: TMS

TMS-Sham

SHAM COMPARATOR

This is a sham TMS condition

Device: TMS

Interventions

TMS DEVICE

Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.

Also known as: Transcranial Magnetic Stimulation

TMS Therapy; TMS-Sham

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with GAD as the principal or co-principal disorder
• Clinical Global Impression Score ≥ 4
• Hamilton Anxiety Rating Scale ≥ 18
• Hamilton Rating Scale for Depression ≤ 17
• 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 past 3 months.
• Current serious suicidal or homicidal ideation, and/or serious suicidal attempt within 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, 06105, United States

Location

Related Publications (1)

• Diefenbach GJ, Bragdon LB, Zertuche L, Hyatt CJ, Hallion LS, Tolin DF, Goethe JW, Assaf M. Repetitive transcranial magnetic stimulation for generalised anxiety disorder: a pilot randomised, double-blind, sham-controlled trial. Br J Psychiatry. 2016 Sep;209(3):222-8. doi: 10.1192/bjp.bp.115.168203. Epub 2016 May 19.

  PMID: 27198484 DERIVED

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Results Point of Contact

• Title: Gretchen J. Diefenbach, Ph.D
• Organization: The Institute of Living

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
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 25, 2012
• First Posted: August 8, 2012
• Study Start: May 1, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: April 27, 2016
• Results First Posted: January 7, 2016

Record last verified: 2016-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)