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Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01815099
Recruitment Status : Terminated (The remaining eligible participants declined to participate.)
First Posted : March 20, 2013
Results First Posted : April 10, 2017
Last Update Posted : April 10, 2017
Sponsor:
Collaborator:
Neuronetics
Information provided by (Responsible Party):
Hartford Hospital

Study Description
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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.

Condition or disease Intervention/treatment Phase
Generalized Anxiety Disorder Device: rTMS Treatment Not Applicable

Detailed Description:
We expected to enroll five patients with GAD who failed to respond to a sham (placebo) TMS intervention. In this pilot study we enrolled three participants into a protocol including 10 rTMS sessions (twice a week for five weeks) and one into a protocol including 15 rTMS sessions (three times a week for five weeks). Assessments occurred at pretreatment and at posttreatment.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 4 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Transcranial Magnetic Stimulation Treatment for Generalized Anxiety Disorder: Substudy #2
Study Start Date : May 2014
Actual Primary Completion Date : August 2015
Actual Study Completion Date : August 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anxiety

Arms and Interventions
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Arm Intervention/treatment
Experimental: rTMS Treatment
Clinical participants will receive rTMS
 Device: rTMS Treatment
Either 10 or 15 rTMS sessions (2 or 3 times/week for 5 weeks, respectively)
Other Name: Neurostar


Outcome Measures
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Primary Outcome Measures :
  1. Change in The Structured Interview Guide for the Hamilton Anxiety Rating Scale (SIGH-A) Before and After TMS Treatment. [ Time Frame: Approximately 1 week prior to initial TMS treatment session, 1 week after final TMS treatment session ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01815099


Locations
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United States, Connecticut
Hartford Hospital
Hartford, Connecticut, United States, 06106
Sponsors and Collaborators
Hartford Hospital
Neuronetics
Investigators
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Principal Investigator: Gretchen J Diefenbach, Ph.D. Hartford Hospital
More Information
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Responsible Party: Hartford Hospital
ClinicalTrials.gov Identifier: NCT01815099    
Other Study ID Numbers: DIEF003523.3
First Posted: March 20, 2013    Key Record Dates
Results First Posted: April 10, 2017
Last Update Posted: April 10, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Anxiety Disorders
Mental Disorders