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.

Lead Sponsor:

Stanford University

Stanford Investigator(s):

Intervention(s):

  • Device: Accelerated theta burst stimulation
  • Device: Sham stimulation

Phase:

N/A

Eligibility


Inclusion Criteria:

   - 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
   information.

   - 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
   SSI-M).

   - 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
   (ketamine)

Exclusion Criteria:

   - 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
   blinding.

   - 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
   Use Disorder.

   - 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

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Eleanor Cole, PhD
Not Recruiting