Back to resultsTranscranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Primary Purpose
Generalized Anxiety Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TMS
Sponsored by
About this trial
This is an interventional treatment trial for Generalized Anxiety Disorder
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
Sites / Locations
- Hartford Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
TMS Therapy
TMS-Sham
Arm Description
TMS treatment
This is a sham TMS condition
Outcomes
Primary Outcome Measures
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.
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.
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01659736
First Posted
May 25, 2012
Last Updated
March 25, 2016
Sponsor
Hartford Hospital
Collaborators
Neuronetics
1. Study Identification
Unique Protocol Identification Number
NCT01659736
Brief Title
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Official Title
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hartford Hospital
Collaborators
Neuronetics
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Generalized Anxiety Disorder
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
26 (Actual)
8. Arms, Groups, and Interventions
Arm Title
TMS Therapy
Arm Type
Experimental
Arm Description
TMS treatment
Arm Title
TMS-Sham
Arm Type
Sham Comparator
Arm Description
This is a sham TMS condition
Intervention Type
Device
Intervention Name(s)
TMS
Other Intervention Name(s)
Transcranial Magnetic Stimulation
Intervention Description
Treatment will entail daily (5 days/week) sessions of TMS for 6 weeks.
Primary Outcome Measure Information:
Title
Change in the Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) at Post-treatment and 3-month Follow-up.
Description
Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) scores range from 0-56 with higher scores indicating more severe anxiety.
Time Frame
Pretreatment, Post-treatment (6 weeks after pretreatment), 3-month follow-up
Title
Responder Status
Description
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.
Time Frame
Post-treatment, 6 weeks
Title
Remission Status
Description
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.
Time Frame
post-treatment, 6 weeks
Title
Responder Status
Description
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.
Time Frame
3-month follow-up
Title
Remission Status
Description
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.
Time Frame
3-month follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gretchen J Diefenbach, Ph.D.
Organizational Affiliation
Hartford Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hartford Hospital
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
27198484
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.
Results Reference
derived
Learn more about this trial
Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder
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