Generalized Anxiety Disorder Clinical Trial
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT03420456 -
Transcranial Pulse Near-Infrared Light in Generalized Anxiety Disorder: a Placebo-Controlled Study
|
N/A | |
| Active, not recruiting |
NCT05530642 -
An Augmented Training Program for Preventing Post-Traumatic Stress Injuries Among Diverse Public Safety Personnel
|
N/A | |
| Withdrawn |
NCT02382224 -
Worry Exposure for Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT02256566 -
Cognitive Training for Mood and Anxiety Disorders
|
N/A | |
| Completed |
NCT02306356 -
Internet-delivered Treatment for Children With Anxiety Disorders in a Rural Area; an Open Trial in a Clinical Setting
|
N/A | |
| Completed |
NCT01958788 -
Testing Beliefs About Uncertainty in the Treatment of Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01681329 -
Cognitive-Behavioral Treatment and Interpretation Modification Training for Adults With Generalized Anxiety Disorder
|
N/A | |
| Completed |
NCT01342120 -
PHARMO Institute Seroquel Safety Study
|
N/A | |
| Completed |
NCT01201967 -
A Collaborative Care Program to Improve Treatment of Depression and Anxiety Disorders in Cardiac Patients
|
Phase 4 | |
| Completed |
NCT01337713 -
Efficacy of Massage Therapy in the Treatment of Generalized Anxiety Disorder (GAD)
|
N/A | |
| Completed |
NCT00961298 -
An Open Label Trial of Duloxetine in the Treatment of Irritable Bowel Syndrome and Comorbid Generalized Anxiety Disorder
|
Phase 4 | |
| Completed |
NCT01971203 -
Efficacy of Extended-release Quetiapine (Seroquel XR) as Adjunctive Therapy to Cognitive Behavioral Therapy in the Treat
|
N/A | |
| Completed |
NCT01203293 -
Cognitive Behavioral Therapy (CBT) for Latinos With Generalized Anxiety Disorder in the General Medical Sector
|
Phase 1 | |
| Completed |
NCT00711737 -
Study of the Changes in Metabolic Parameters in Patients Treated With Escitalopram for Six Months
|
N/A | |
| Completed |
NCT00744627 -
Efficacy and Safety of Vortioxetine (Lu AA21004) for Treatment of Generalized Anxiety Disorder in Adults.
|
Phase 3 | |
| Terminated |
NCT01244711 -
Open-Label Pilot Study to Examine the Value of Substituting Quetiapine for Benzodiazepines
|
Phase 4 | |
| Completed |
NCT00537615 -
An Open-label Study to Investigate the Absorption, Metabolism and Excretion of Radiolabeled PD 0332334 in Six Healthy Male Volunteers
|
Phase 1 | |
| Completed |
NCT00525226 -
Evaluating the Effects of Stress in Pregnancy
|
N/A | |
| Completed |
NCT00515242 -
Therapeutic Massage for Generalized Anxiety Disorder
|
Phase 1/Phase 2 | |
| Completed |
NCT00368745 -
Efficacy and Safety of Pregabalin vs Placebo for Generalized Anxiety Disorder (GAD) Symptoms in Subjects Discontinuing Benzodiazepine Treatment and Remaining 6 Weeks on Study Medication, Free From Benzodiazepine Use.
|
Phase 3 |