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 not accepting patients for this trial.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

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

Phase:

N/A

Eligibility


Inclusion Criteria:

   - Male or female, 22 to 75 years of age.

   - Able to provide informed consent.

   - Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major
   Depressive Episode (MDE).

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

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

   - Participants must qualify as "Moderately Treatment Refractory" or "High Treatment
   Refractory" using the Maudsley staging method.

   - Meet the threshold on the total HAMD17 score of >/=20 at both screening and baseline
   visits (Day -5/-14 and Day 0).

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

   - If female, a status of non-childbearing potential or use of an acceptable form of
   birth control. The form of birth control will be documented at screening and baseline.

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

Exclusion Criteria:

   - Female of childbearing potential who is not willing to use one of the specified forms
   of birth control during the study.

   - Female that is pregnant or breastfeeding.

   - Female with a positive pregnancy test at participation.

   - History of epilepsy.

   - History of rTMS exposure.

   - History of any implanted device or psychosurgery for depression.

   - History of shrapnel or metal in the head or skull.

   - History of OCD.

   - History of autism spectrum disorder.

   - History of intractable migraine

   - History of independent sleep disorder.

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

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

   - Cognitive impairment (including dementia)

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

   - Current mania or psychosis

   - Showing symptoms of withdrawal from alcohol or benzodiazepines

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

   - Any other indication the PI feels would compromise data

   - Active suicidal ideation or a suicide attempt with in the past 90 days

   - A diagnosis of bipolar type 1 or 2

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

   - The presence of diagnosis of primary generalized anxiety disorder or personality
   disorder

   - Under 22 years or age or over 75 years of age at time of screening

Ages Eligible for Study

22 Years - 75 Years

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

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