Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
Trial ID or NCT#
NCT03680781
Status
RECRUITING
Purpose
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.
Official Title
Accelerated Theta Burst in Treatment-Resistant Depression: A Dose Finding and Biomarker Study
Eligibility Criteria
Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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
Investigator(s)
Ian H. Kratter, MD, PhD
Psychiatrist
Clinical Assistant Professor, Psychiatry and Behavioral Sciences
Nolan Williams
Deep brain stimulation specialist,
Neuroimaging specialist,
Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)
Contact us to find out if this trial is right for you.
Contact
Claudia Tischler, BA
650-498-8535
View on ClinicalTrials.gov
