Status:
COMPLETED
Repetitive Magnetic Transcranial Stimulation (rTMS) in the Treatment of Generalized Anxiety Disorder (GAD)
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
Phillis and Brian Harvey Foundation
Saban Family Foundation
Conditions:
Generalized Anxiety Disorder
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
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 ...
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 tas...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
August 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 1 2007
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00662584
Start Date
August 1 2006
End Date
April 1 2007
Last Update
August 19 2016
Active Locations (1)
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1
UCLA
Los Angeles, California, United States, 90024