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Personalized Therapeutic Neuromodulation for Anhedonic Depression
Recruiting
I'm InterestedTrial ID: NCT05144789
Purpose
This study will investigate the anti-anhedonic efficacy of a novel neurostimulation strategy
termed accelerated intermittent theta burst stimulation (aiTBS) in participants with
treatment resistant depression (TRD).
Official Title
Personalized Therapeutic Neuromodulation for Anhedonic Depression
Stanford Investigator(s)
David Spiegel
Jack, Lulu and Sam Willson Professor of Medicine
Eligibility
Inclusion Criteria:
1. Male or Female, between the ages of 18 and 80 at the time of screening.
2. Able to read, understand, and provide written, dated informed consent prior to
screening. Proficiency in English sufficient to complete questionnaires / follow
instructions during fMRI assessments and aiTBS interventions. Stated willingness to
comply with all study procedures, including availability for the duration of the
study, and to communicate with study personnel about adverse events and other
clinically important information.
3. Currently diagnosed with Major Depressive Disorder (MDD) or Bipolar Disorder type II
and meets criteria for a Major Depressive Episode, according to the criteria defined
in the Diagnosis and Statistical Manual of Mental Disorders, Fifth Edition, Text
Revision (DSM-5).
4. Medical records confirming a history of moderate to severe treatment-resistance as
defined by a score of 7-14 on the Maudsley Staging Method (MSM).
5. MADRS score of ≥20 at screening (Visit 1).
6. TMS naive.
7. Access to ongoing psychiatric care before and after completion of the study.
8. Must be on a stable antidepressant therapeutic regimen for 6 weeks prior to study
enrollment and agree to continue this regimen throughout the study period.
9. In good general health, as evidenced by medical history.
10. For females of reproductive potential: use of highly effective contraception for at
least 1 month prior to screening and agreement to use such a method during study
participation.
Exclusion Criteria:
1. Pregnancy
2. Primary psychiatric condition other than MDD requiring treatment except stable
co-morbid anxiety disorder
3. History of or current psychotic disorder or bipolar disorder
4. Diagnosis of Intellectual Disability or Autism Spectrum Disorder
5. Current moderate or severe substance use disorder or demonstrating signs of acute
substance withdrawal
6. Urine screening test positive for illicit substances
7. Active suicidal ideation (defined as an MSSI > 8) or a suicide attempt within the past
90 days
8. Any history of ECT (greater than 8 sessions) without meeting responder criteria
9. Recent (during the current depressive episode) or concurrent use of rapid acting
antidepressant agent (i.e., ketamine or a course of ECT)
10. History of significant neurologic disease, including dementia, Parkinson's or
Huntington's disease, brain tumor, seizure disorder, subdural hematoma, multiple
sclerosis, or history of significant head trauma
11. Contraindication to receiving rTMS (e.g., metal in head, history of seizure, known
brain lesion)
12. Contraindication to MRI (ferromagnetic metal in their body)
13. Treatment with another investigational drug or other intervention within the study
period
14. Any other condition deemed by the PI to interfere with the study or increase risk to
the participant
Intervention(s):
device: Active TBS-DLPFC
device: Active TBS-DMPFC
device: Sham TBS-DLPFC or DMPFC
Recruiting
I'm InterestedContact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Romina Nejad, MSc
650-497-3933