Trial Search Results

Establishing a Dose-response Relationship With Accelerated Transcranial Magnetic Stimulation

This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In a double-blind, randomized, sham-controlled fashion, half the participants will receive accelerated theta-burst stimulation while half will receive sham treatment.

Stanford is currently accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Active TBS-DLPFC
  • Device: Sham TBS-DLPFC

Phase:

N/A

Eligibility


Inclusion Criteria:

   1. Between the ages of 22 and 65 at the time of screening

   2. Able to read, understand, and provide written, dated informed consent prior to
   screening. Able to follow instructions during fMRI, assessments, and SAINT treatments.
   Participants will be deemed likely to comply with study protocol and communicate with
   study personnel about adverse events and other clinically important information.

   3. Currently diagnosed with Major Depressive Disorder (MDD) 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-V-TR)

   4. Meet the threshold on the total MADRS score of ≧20 at screening/baseline.

   5. In good general health, as ascertained by medical history.

   6. Qualify as a "moderate or severe treatment refractory" on the Maudsley staging method
   (MSM), defined by a score of 7-14 on the MSM.

   7. Must have a stable psychiatrist during study enrollment who confirms MDD/current MDE

   8. Must be on a stable anti-depressant regimen for 6 weeks prior to study enrollment and
   agree to continue this regimen during study period

   9. Agree to and able to have at least 6 fMRI scan sessions as well as 5 days of 10 SAINT
   sessions per day (for each course of SAINT).

10. If participant is of childbearing potential and not already pregnant, must agree to
   use adequate contraception prior to study and for the duration of study participation.

11. MSSI score ≤ 9

12. Not in a current state of Mania (YMRS) or psychosis (MINI)

13. Must have failed at least one prior medication for MDD

Exclusion Criteria:

   1. Any structural lesion e.g. structural neurological condition, more subcortical lesions
   than would be expected for age, stroke effecting stimulated area or connected areas or
   any other clinically significant abnormality that might affect safety, study
   participation, or confound interpretation of study results.

   2. Metal implant in brain (e.g. deep brain stimulation), cardiac pacemaker, or cochlear
   implants

   3. History of epilepsy/ seizures (including history of withdrawal/ provoked seizures)

   4. Shrapnel or any ferromagnetic item in the head

   5. Pregnancy

   6. Autism Spectrum disorder

   7. Any current or past history of any physical condition which in the investigator's
   opinion might put the subject at risk or interfere with study results interpretation

   8. Active substance abuse (within the past 6 months) or intoxication verified by
   toxicology screen--of cocaine, amphetamines, benzodiazepines, alcohol.

   9. Cognitive impairment (including dementia)

10. Current severe insomnia (must sleep a minimum of 4 hours the night before stimulation)

11. Current mania or psychosis

12. Showing symptoms of withdrawal from alcohol or benzodiazepines

13. Parkinsonism or other movement d/o determined by PI to interfere with treatment

14. Any other indication the PI feels would comprise data.

15. Any exposure to previous TMS in the past

16. Active suicidal ideation or a suicide attempt within the past 90 days

17. A diagnosis of obsessive-compulsive disorder (OCD)

18. A diagnosis of bipolar disorder type 1 or type 2

19. Any history of psycho surgery for depression

20. Any history of myocardial infarction, CABG, CHF, or other cardiac history deemed by
   the PI to interfere with the study

21. The presence or diagnosis of primary generalized anxiety disorder or personality
   disorder

22. History of intractable migraine

23. Unstable symptoms between screening and baseline as defined by a >/=30% decrease in
   MADRS score.

24. Under 22 years of age or over 65 years of age at time of screening

Ages Eligible for Study

22 Years - 65 Years

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Romina Nejad, MSc
650-497-3933
Not Recruiting