Generalized Anxiety DisorderPhase 3NCT00662584
Repetitive Magnetic Transcranial Stimulation (rTMS) in the Treatment of Generalized Anxiety Disorder (GAD)
A Phase 3 study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Generalized Anxiety Disorder, run by University of California, Los Angeles at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Generalized Anxiety Disorder
- What is being tested?
- Repetitive transcranial magnetic stimulation (rTMS)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2006to Apr 2007
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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.
Read the 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.
- Conditions
- Generalized Anxiety Disorder
- Being tested
- Repetitive transcranial magnetic stimulation (rTMS)
- Keywords
- repetitive magnetic transcranial stimulation (rTMS), functional magnetic resonance imaging (fMRI)
- Medical subject headings
- Generalized Anxiety Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repetitive transcranial magnetic stimulation (rTMS)Procedure or surgery
transcranial magnetic stimulation (TMS) at .5 HZ for 20s
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | This was an open-label study - all subjects received the intervention (rTMS treatment) Receives: Procedure: Repetitive transcranial magnetic stimulation (rTMS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A)
Measured: Week 0, 3, 6
The Clinical Global Impression (CGI) Scale of Severity/Improvement
Measured: Week 0, 3, 6
Secondary outcomes (2)
Structured Interview for the Hamilton Depression Rating Scale (SIGH-D)
Measured: Week 0 and 6
The Side-Effects Questionnaire
Measured: Week 0, 3, 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2008 (estimated)
- Study startAug 2006
- Primary completionMar 2007
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Collaborators
- Phillis and Brian Harvey Foundation, Saban Family Foundation
- Responsible party
- Sponsor
- Investigators
- Alexander Bystritsky, MD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00662584
- Sponsor's protocol ID
- 05-05-045-01
- Status last verified
- Aug 2016
- First submitted
- 14 Apr 2008
- Last updated
- 19 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT00662584
- Acronym / sponsor ID
- 05-05-045-01
- Conditions
- Generalized Anxiety Disorder
- Keywords
- repetitive magnetic transcranial stimulation (rTMS), functional magnetic resonance imaging (fMRI)
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of California, Los AngelesUniversity, hospital or other
- Collaborators
- Phillis and Brian Harvey Foundation, Saban Family Foundation
- Study start
- Aug 2006
- Primary completion
- Mar 2007 (actual)
- Study completion
- Apr 2007 (actual)
- First posted
- 21 Apr 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Procedure: Repetitive transcranial magnetic stimulation (rTMS)This was an open-label study - all subjects received the intervention (rTMS treatment) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repetitive transcranial magnetic stimulation (rTMS)transcranial magnetic stimulation (TMS) at .5 HZ for 20s | Procedure or surgery | 1 |
Primary outcome
Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A)
Time frame: Week 0, 3, 6
The Clinical Global Impression (CGI) Scale of Severity/Improvement
Time frame: Week 0, 3, 6
2 secondary outcomes
Structured Interview for the Hamilton Depression Rating Scale (SIGH-D)
Time frame: Week 0 and 6
The Side-Effects Questionnaire
Time frame: Week 0, 3, 6
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander Bystritsky, MD principal investigator
University of California, Los Angeles
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Repetitive transcranial magnetic stimulation (rTMS) in people with Generalized Anxiety Disorder, run by University of California, Los Angeles at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Structured Interview for the Hamilton Anxiety Rating Scale (SIGH-A) (time frame: Week 0, 3, 6). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2016.