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.
- Device: Active TBS-DLPFC
- Device: Sham TBS-DLPFC
- Device: Open label TBS-DLPFC
- 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).
- 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
- 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