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TMS for Depression and Anxiety
Study Summary
This trial will compare two different ways of using transcranial magnetic stimulation to treat people with major depressive disorder. The goal is to see if one method is better than the other at treating both depression and anxiety.
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Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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- You have a condition called seizure disorder, which makes you unable to receive a specific type of treatment called rTMS.You have been diagnosed with bipolar disorder.You have had a serious problem with drugs or alcohol in the past six months, except for cannabis and nicotine.You have been diagnosed with major depressive disorder by a medical professional and at least one medication used to treat it has not worked for you.You are currently experiencing severe mental health symptoms that affect your thinking and perception.You have moderate or severe autism.You are currently having thoughts of hurting yourself or thinking about suicide.You have severe pain or illness that gets worse when lying down in the MRI scanner.You have been diagnosed with a type of mental illness called schizophrenia or a related disorder.You have a strong fear of being in small, enclosed spaces (like an MRI machine).You have a condition called dementia, which is diagnosed by a specialist doctor who treats problems with the brain.You currently have a mood disorder caused by drugs or substances you have used.Your score on the Beck Anxiety Inventory (BAI) is 16 or higher.
- Group 1: Dysphoric target
- Group 2: Anxiosomatic target
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Has the FDA sanctioned Transcranial magnetic stimulation?
"There is some evidence to suggest that Transcranial magnetic stimulation is safe, thus its safety score sits at a 2. This Phase 2 trial has yet to collect data attesting to the efficacy of this intervention."
Are there any slots currently available for participants of this experiment?
"The clinical trial is still in the recruitment phase, which began on February 3rd 2021 and was refreshed as recently as August 1st 2022. This data can be confirmed via clinicaltrials.gov."
What outcomes are researchers hoping to obtain from this clinical trial?
"As a primary measure of the trial's efficacy, patients will be evaluated using Beck Anxiety Inventory (BAI) scores across Baseline, 3 and 6 week time frames. Secondary assessments include Multidimensional battery of emotional questionnaires which assesses temperament, reactivity to emotion and impulsivity; Resting-state functional MRI scans for assessing brain connectivity before/after treatment; and Multidimensional task-based emotional assessment via interactive computerized tasks including Aversion-Reward Conflict, Emotion Conflict Resolution etc., each yielding results in accuracy & reaction time."
Does the protocol for this trial preclude people under age 55 from participating?
"This clinical trial seeks volunteers aged 18 to 65 years old."
Who qualifies to participate in this medical trial?
"This clinical trial is enrolling 40 persons with depression that are between 18 and 65 years of age. Essential criteria for inclusion include the following: FDA-sanctioned TMS classification, DSM-5 diagnosis of major depressive disorder with a prior unsuccessful antidepressant attempt, BDI score over 20, and BAI score above 16."
How many individuals can the clinical trial accommodate?
"Affirmative. According to clinicaltrials.gov, this trial is actively seeking volunteers and it was posted on February 3rd 2021 with the latest update registered on August 1st 2022. Forty individuals are sought from a single site for inclusion in the study."
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