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

NCT00662584 | Completed Phase 3 DMC

• 1 other identifier: 05-05-045-01
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Generalized Anxiety Disorder

Keywords

repetitive magnetic transcranial stimulation (rTMS); functional magnetic resonance imaging (fMRI)

Outcome Measures

Primary Outcomes (2)

• Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A)

  Week 0, 3, 6

• The Clinical Global Impression (CGI) Scale of Severity/Improvement

  Week 0, 3, 6

Secondary Outcomes (2)

• Structured Interview for the Hamilton Depression Rating Scale (SIGH-D)

  Week 0 and 6

• The Side-Effects Questionnaire

  Week 0, 3, 6

Study Arms (1)

1

EXPERIMENTAL

This was an open-label study - all subjects received the intervention (rTMS treatment)

Procedure: Repetitive transcranial magnetic stimulation (rTMS)

Interventions

Repetitive transcranial magnetic stimulation (rTMS) PROCEDURE

transcranial magnetic stimulation (TMS) at .5 HZ for 20s

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, Los Angeles: lead
• Phillis and Brian Harvey Foundation: collaborator
• Saban Family Foundation: collaborator

Study Sites (1)

UCLA

Los Angeles, California, 90024, United States

Location

MeSH Terms

Conditions

Generalized Anxiety Disorder

Interventions

Transcranial Magnetic Stimulation

Condition Hierarchy (Ancestors)

Anxiety Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Magnetic Field Therapy; Therapeutics

Study Officials

• Alexander Bystritsky, MD

  University of California, Los Angeles

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 14, 2008
• First Posted: April 21, 2008
• Study Start: August 1, 2006
• Primary Completion: March 1, 2007
• Study Completion: April 1, 2007
• Last Updated: August 19, 2016

Record last verified: 2016-08

Locations

US (1)