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

Last updated: August 17, 2016
Sponsor: University of California, Los Angeles
Overall Status: Completed

Phase

3

Condition

Anxiety Disorders

Panic Disorders

Mood Disorders

Treatment

N/A

Clinical Study ID

NCT00662584
05-05-045-01
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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 bythe MINI.

  • Sexually active female patients of childbearing potential must be practicing at leastone or more the following methods of contraception during the study: intrauterinedevice (IUD), barrier method in combination with a spermicide, oral/hormonalcontraception or abstinence. Female patients of childbearing potential must have anegative pregnancy test prior to receiving study drug.

  • Written informed consent must be obtained from the subject prior to studyparticipation.

  • The subject is in good medical health or with chronic medical conditions which arecurrently 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 atscreening.

Exclusion

Exclusion Criteria:

  • The subject meets DSM-IV criteria for an Axis I diagnosis (other than GAD) as theprimary diagnosis (i.e., schizophrenia, mood disorder, psychosis, anorexia nervosa) asdetermined by the MINI.

  • The subject is clinically judged by the investigator to be at risk for suicide or isacutely suicidal as objectively measured by the MINI and MSE.

  • The subject is clinically judged by the investigator to be at risk for homicide or isacutely homicidal as objectively measured by the MINI and MSE.

  • The subject has a psychiatric condition that would require inpatient, or partialpsychiatric 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 metastaticpotential or progressive neurological disorders) which could impair reliableparticipation in the trial or necessitate the use of medication not allowed by thisprotocol.

  • The subject is pregnant, planning to become pregnant, or nursing. If a subject becomespregnant, she will be discontinued immediately and followed appropriately.

  • Concomitant therapy with another investigational drug, or participation in aninvestigational drug study within one month prior to entering this study.

  • Current psychotherapeutic treatment except for treatment with Specific ReuptakeInhibitor (SSRIs) medications which include: Fluoxetine (Prozac), Paroxetine (Paxil),Sertraline (Zoloft), Luvox (Fluvoxamine), and Citalopram. Potential subjects mayremain on one of the SSRI medications provided that he or she has been on a stabledose for at least 4 weeks prior to entering this study; this dose remains stablethroughout the remainder of this study; and it can be determined that this medicationis not exacerbating the anxiety symptoms.

  • History of poor compliance or in the Investigator's judgment patients any subjectwhose 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 38which suggests a moderate to severe clinical level of depressive symptoms

Study Design

Total Participants: 10
Study Start date:
August 01, 2006
Estimated Completion Date:
April 30, 2007

Study 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.

Connect with a study center

  • UCLA

    Los Angeles, California 90024
    United States

    Site Not Available

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