Bilateral Accelerated Theta Burst in Treatment-Resistant Bipolar Depression
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|ClinicalTrials.gov Identifier: NCT03953417|
Recruitment Status : Active, not recruiting
First Posted : May 16, 2019
Last Update Posted : November 22, 2021
|Condition or disease||Intervention/treatment||Phase|
|Treatment Resistant Depression||Device: Bilateral accelerated intermittent theta-burst treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Bilateral Accelerated Theta Burst Stimulation in Treatment-Resistant Bipolar Depression|
|Actual Study Start Date :||July 1, 2019|
|Estimated Primary Completion Date :||July 1, 2023|
|Estimated Study Completion Date :||July 30, 2023|
Experimental: Bilateral accelerated intermittent theta burst treatment
All participants will receive accelerated intermittent theta-burst stimulation.
Device: Bilateral accelerated intermittent theta-burst treatment
All participants will receive bilateral accelerated intermittent theta-burst stimulation to the left and right DLPFC. Treatment will be targeted by utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.
Stimulation will be delivered to left and right-DLPFC using the MagPRo stimulator.
- Change from baseline Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Baseline and immediately post-treatment ]
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
The MADRS uses a 0 to 6 severity scale, scored following the interview. Scoring/Interpretation: Higher scores indicate increasing depressive symptoms. ... Cut-off points include: 0 to 6 - symptom absent, 7 to 19 - mild depression, 30 to 34 - moderate, 35 to 60 - severe depression.
- Change from baseline Young Mania Rating Scale (YMRS) [ Time Frame: Baseline and immediate post-treatment ]
The Young Mania Rating Scale (YMRS) is one of the most frequently utilized rating scales to assess manic symptoms. The scale has 11 items and is based on the patient's subjective report of his or her clinical condition.
There are four items that are graded on a 0 to 8 scale (irritability, speech, thought content, and disruptive/aggressive behavior), while the remaining seven items are graded on a 0 to 4 scale. These four items are given twice the weight of the others to compensate for poor cooperation from severely ill patients.
Typical YMRS baseline scores can vary a lot. They depend on the patients' clinical features such as mania (YMRS = 12), depression (YMRS = 3), or euthymia (YMRS = 2).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03953417
|United States, California|
|Palo Alto, California, United States, 94305|
|Principal Investigator:||Ian Kratter, MD, PhD||Stanford University|