Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study (NCT03680781) | Clinical Trial Compass
CompletedNot Applicable
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
United States40 participantsStarted 2018-04-13
Plain-language summary
This study evaluates the effectiveness of re-treatment using accelerated schedule of intermittent theta-burst stimulation for treatment-resistant depression. This is an open label study.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Male or female, 18 to 75 years of age.
* Able to provide informed consent.
* Diagnosed with Major Depressive Disorder (MDD) or bipolar affective disorder 2 and currently experiencing a Major Depressive Episode (MDE).
* prior exposure to rTMS
* Participants must qualify as "moderate or severe treatment refractory" using the Maudsley staging method.
* Participants may continue antidepressant regimen, but must be stable for 6 weeks prior to enrollment in the study. They must maintain that same antidepressant regimen throughout the study duration.
* Participants are required to have a stable psychiatrist for the duration of study enrollment.
Exclusion Criteria:
* History of MI, CABG, CHF, or other cardiac history
* Any neurological conditions
* History of epilepsy
* OCD
* Independent sleep disorder
* Autism Spectrum Disorder
What they're measuring
1
Change in Hamilton Depression Rating Scale 21-Item Score
Timeframe: Difference between baseline and follow up at one month after the final aiTBS treatment (on day 5)