Repetitive Magnetic Transcranial Stimulation (rTMS) in the Treatment of Generalized Anxiety Disorder (GAD)

This study has been completed.
Sponsor:
Collaborators:
Phillis and Brian Harvey Foundation
Saban Family Foundation
Information provided by:
University of California, Los Angeles
ClinicalTrials.gov Identifier:
NCT00662584
First received: April 14, 2008
Last updated: April 17, 2008
Last verified: April 2008
  Purpose

Repetitive transcranial magnetic stimulation (rTMS) is a noninvasive method that holds promise for treating several psychiatric disorders. Yet the most effective location and parameters for treatment need more exploration. Also, whether rTMS is an effective treatment for individuals with a DSM-IV diagnosis of Generalized Anxiety Disorder (GAD) has not been empirically tested. The goal of this pilot study is to evaluate whether fMRI guided rTMS is effective in reducing symptoms of GAD.


Condition Intervention Phase
Generalized Anxiety Disorder
Procedure: Repetitive transcranial magnetic stimulation (rTMS)
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Efficacy of Functional Magnetic Resonance Imaging (fMRI) Guided Low Frequency Repetitive Magnetic Transcranial Stimulation (rTMS) Therapy on Symptoms of Generalized Anxiety Disorder (GAD)

Resource links provided by NLM:


Further study details as provided by University of California, Los Angeles:

Primary Outcome Measures:
  • Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: No ]
  • The Clinical Global Impression (CGI) Scale of Severity/Improvement [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Structured Interview for the Hamilton Depression Rating Scale (SIGH-D) [ Time Frame: Week 0 and 6 ] [ Designated as safety issue: No ]
  • The Side-Effects Questionnaire [ Time Frame: Week 0, 3, 6 ] [ Designated as safety issue: Yes ]

Enrollment: 10
Study Start Date: August 2006
Study Completion Date: April 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
This was an open-label study - all subjects received the intervention (rTMS treatment)
Procedure: Repetitive transcranial magnetic stimulation (rTMS)
transcranial magnetic stimulation (TMS) at .5 HZ for 20s

Detailed Description:

This study utilized a 3-week open-label design to evaluate the efficacy of fMRI guided rTMS in the treatment of GAD.

We first used functional magnetic resonance imaging (fMRI) during the gambling task to localize anxiety-related brain activations in each individual participant, and then used this information to guide treatment with repetitive transcranial magnetic stimulation (rTMS).

TMS was delivered to the target site at a frequency of 1 Hz for 20 minutes (900 total pulses). The intensity of the TMS was set to 90% of the passive motor threshold for each participant.

The primary efficacy measures include the Clinical Global Impression of Improvement (CGI-I) and the Hamilton Anxiety Rating Scale (HARS). Response to treatment was defined as a reduction of 50% or more on the HARS and symptom remission was defined as a CGI-I score of 1 or 2 ("much improved" or "very much improved" respectively) and a score ≤ 8 on the HARS. Data was entered anonymously into an Excel spreadsheet and analyzed by the UCLA Semel Institute Statistical Core. The analysis was done on the intent to treat sample using last observation carried forward (LOCF). A one-sample paired t-test was used to compare endpoint to baseline means on the HARS, with a significance level set at p= 0.05, two-tailed.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • The subject is male or female outpatients age 18 to 65 years, inclusive
  • The subject meets DSM-IV criteria for Generalized Anxiety Disorder as determined by the MINI.
  • Sexually active female patients of childbearing potential must be practicing at least one or more the following methods of contraception during the study: intrauterine device (IUD), barrier method in combination with a spermicide, oral/hormonal contraception or abstinence. Female patients of childbearing potential must have a negative pregnancy test prior to receiving study drug.
  • Written informed consent must be obtained from the subject prior to study participation.
  • The subject is in good medical health or with chronic medical conditions which are currently stable.
  • No current abuse of alcohol or other substance.
  • The subject has a total score of 20 or more on the SIGH-A at screening.
  • The subject has a Clinical Global Impression (CGI) Severity score of 4 or more at screening.

Exclusion Criteria:

  • The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD) as the primary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) as determined by the MINI.
  • The subject is clinically judged by the investigator to be at risk for suicide or is acutely suicidal as objectively measured by the MINI and MSE.
  • The subject is clinically judged by the investigator to be at risk for homicide or is acutely homicidal as objectively measured by the MINI and MSE.
  • The subject has a psychiatric condition that would require inpatient, or partial psychiatric hospitalization.
  • Seizure disorders.
  • Significant history of medical disease (i.e. cardiovascular, hepatic (e.g. cirrhosis, hepatitis B or C) renal, gynecological, musculoskeletal, neurological, gastrointestinal, metabolic, hematological, endocrine, cancer with a metastatic potential or progressive neurological disorders) which could impair reliable participation in the trial or necessitate the use of medication not allowed by this protocol.
  • The subject is pregnant, planning to become pregnant, or nursing. If a subject becomes pregnant, she will be discontinued immediately and followed appropriately.
  • Concomitant therapy with another investigational drug, or participation in an investigational drug study within one month prior to entering this study.
  • Current psychotherapeutic treatment except for treatment with Specific Reuptake Inhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil), Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects may remain on one of the SSRI medications provided that he or she has been on a stable dose for at least 4 weeks prior to entering this study; this dose remains stable throughout the remainder of this study; and it can be determined that this medication is not exacerbating the anxiety symptoms.
  • History of poor compliance or in the Investigator's judgment patients any subject whose treatment as an outpatient would be clinically contraindicated
  • The subject has attempted suicide one or more times within the past twelve months
  • The subject has a Structured Hamilton Depression Rating Scale (SIGH-D) score above 38 which suggests a moderate to severe clinical level of depressive symptoms
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00662584

Locations
United States, California
UCLA
Los Angeles, California, United States, 90024
Sponsors and Collaborators
University of California, Los Angeles
Phillis and Brian Harvey Foundation
Saban Family Foundation
Investigators
Principal Investigator: Alexander Bystritsky, MD University of California, Los Angeles
  More Information

No publications provided

Responsible Party: Alexander Bystritsky, M.D.,, UCLA, Department of Psychiatry
ClinicalTrials.gov Identifier: NCT00662584     History of Changes
Other Study ID Numbers: 05-05-045-01
Study First Received: April 14, 2008
Last Updated: April 17, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Los Angeles:
repetitive magnetic transcranial stimulation (rTMS)
functional magnetic resonance imaging (fMRI)

Additional relevant MeSH terms:
Anxiety Disorders
Disease
Mental Disorders
Pathologic Processes

ClinicalTrials.gov processed this record on October 16, 2014