Clinical trial NCT01659736: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Official title: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Generalized Anxiety Disorder
Lead sponsor: Hartford Hospital
Sponsor class: OTHER
Collaborators: name: Neuronetics
First posted: 2012-08-08
Enrollment: 26
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Detailed description: Participants will complete structural MRI for neuronavigation. Participants will be randomly assigned to treatment condition. TMS or Sham-TMS sessions will occur daily 5 days/week for 6 weeks. Assessments will occur at pretreatment, weekly during treatment, post-treatment, and 3 month.

Eligibility criteria: Inclusion Criteria:

* 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.

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 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

Primary outcomes:
measure: Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
timeFrame: Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up
measure: Responder Status
timeFrame: Post-treatment, 6 weeks
measure: Remission Status
timeFrame: post-treatment, 6 weeks
measure: Responder Status
timeFrame: 3-month follow-up
measure: Remission Status
timeFrame: 3-month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Hartford
country: United States
facility: Hartford Hospital
state: Connecticut
Study officials:
affiliation: Hartford Hospital
name: Gretchen J Diefenbach, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.