Trial Search Results
The Effects of Stanford Accelerated Intelligent Neuromodulation Therapy on Explicit and Implicit Suicidal Cognition
This study evaluates the effects of an accelerated schedule of theta-burst stimulation, termed Stanford Accelerated Intelligent Neuromodulation Therapy (SAINT), on the neural networks underlying explicit and implicit suicidal cognition in inpatients with major depressive disorder.
Stanford is currently not accepting patients for this trial.
- Device: Accelerated theta burst stimulation
- Device: Sham stimulation
- Age 18-75 year old at the time of screening on voluntary or involuntary hold
- Able to read, understand, and provide written, dated informed consent prior to
screening. Participants will be deemed likely to comply with study protocol and
communicate with study personnel about adverse events and other clinically important
- Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder II (BAPD
II), according to the criteria defined in the Diagnosis and Statistical Manual of
Mental Disorders, Fifth Edition, Text Revision (DSM-5).
- Endorse suicidal ideation at baseline (score of ≥5 on SSI-C or a score of ≥9 on the
- Not in a current state of mania (Young Mania Rating Scale) or psychosis (MINI)
- Have to be TMS naive
- In good general health, as ascertained by medical history.
- Agree to and be able to have fMRI scan as well as 5 days of 10 SAINT sessions per day.
- 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.
- No recent use (for the actual depressive episode) of rapid acting antidepressive agent
- Any contraindications to receiving rTMS (e.g., metal implanted in or near the head,
history of seizure, any known brain lesion).
- Metal implants that would contraindicate MRI (ferromagnetic metal in their body)
- Any significant neurologic disease, including dementia, cognitive disorder,
Parkinson's or Huntington's disease, brain tumor, seizure disorder, subdural hematoma,
multiple sclerosis, history of significant head trauma
- Previous exposure to any rTMS approach, as this would limit the integrity of sham
- A primary psychiatric condition other than depression requiring current treatment.
- A history of/or current psychotic disorder or bipolar I disorder.
- Positive urine test for any illicit substances during the baseline visit.
- Moderate or severe use disorder of any other substance with the exception of Tobacco
- An unstable general medical condition.
- No other investigational treatments will be allowed during this study.
- Age>75 and/or significant atrophy of the PFC.
- Pregnancy: The effects of rTMS on the developing human fetus are incipient and still
uncertain. We will not be enrolling pregnant participants to this study. Participants
of childbearing potential must agree to use adequate contraception (hormonal / barrier
method of birth control or abstinence) prior to study entry and for the duration of
study participation. These participants will have a pregnancy test prior to receiving
each rTMS stimulation session. Should a participant become pregnant or suspects
pregnancy while participating in this study, they should inform study staff.
Ages Eligible for Study
18 Years - 75 Years
Genders Eligible for Study