Trial Search Results
Personalized Therapeutic Neuromodulation for Anhedonic Depression
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) or BD. aiTBS is a novel application of repetitive transcranial magnetic stimulation (TMS), that induces remission in 90% of individuals with severe, treatment resistant MDD in 1-5 days.
Stanford is currently accepting patients for this trial.
- Device: Active TBS-DLPFC
- Device: Active TBS-DMPFC
- Device: Sham TBS-DLPFC or DMPFC
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
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
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
6. Urine screening test positive for illicit substances
7. Active suicidal ideation (defined as an MSSI > 8) or a suicide attempt within the past
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
12. Contraindication to MRI (ferromagnetic metal in their body)
13. Treatment with another investigational drug or other intervention within the study
14. Any other condition deemed by the PI to interfere with the study or increase risk to
Ages Eligible for Study
18 Years - 80 Years
Genders Eligible for Study