©2024 Stanford Medicine
SAINT for Treatment of Preoperative Depression to Reduce Opioid Use Following Arthroplasty
Not Recruiting
Trial ID: NCT04195308
Purpose
This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial
magnetic stimulation device for treatment-resistant depression. In a double-blind fashion,
half the participants will receive accelerated theta-burst stimulation while half will
receive sham treatment.
Official Title
Accelerated Intermittent Theta-burst Stimulation for Treatment of Preoperative Depression to Reduce Conversion of Acute to Chronic Opioid Use Following Arthroplasty
Stanford Investigator(s)
Nolan Williams
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)
Eligibility
Inclusion Criteria:
- Male or female, 22 to 80 years of age.
- Able to provide informed consent.
- Diagnosed with Major Depressive Disorder (MDD) and currently experiencing a Major
Depressive Episode (MDE).
- Participants may currently be on a stable and adequate dose of SSRI antidepressant
therapy. Participants may choose to not be on antidepressant therapy for the study
duration, or to be switched from other classes to a medication from the SSRI class.
- Participants may also have a history of intolerance to at least 2 antidepressant
medications. These patients with the intolerance history will not be required to be
currently taking an antidepressant medication.
- 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).
- Meet the threshold on the total MADRS score of >/=20 at both screening and baseline
visits (Day -5/-14 and Day 0).
- Meet the threshold on the total BDI-II 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.
- Concurrent hypnotic therapy (e.g., with zolpidem, zaleplon, melatonin, or trazodone)
will be allowed if the therapy has been stable for at least 4 weeks prior to screening
and if it is expected to remain stable.
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.
- Total HAMD17 score of < 20 at the screen or baseline visits.
- Total MADRS score of < 20 at the screen or baseline visits.
- Total BDI-II score of < 20 at the screen or baseline visits.
- Current diagnosis of a Substance Use Disorder (Abuse or Dependence, as defined by
DSM-IV-TR), with the exception of nicotine dependence, at screening or within six
months prior to screening.
- Current diagnosis of Axis I disorders other than Dysthymic Disorder, Generalized
Anxiety Disorder, Social Anxiety Disorder, Panic Disorder, Agoraphobia, or Specific
Phobia (unless one of these is comorbid and clinically unstable, and/or the focus of
the participant's treatment for the past six months or more).
- History of schizophrenia or schizoaffective disorders, or any history of psychotic
symptoms in the current or previous depressive episodes.
- Any Axis I or Axis II Disorder, which at screening is clinically predominant to their
MDD or has been predominant to their MDD at any time within six months prior to
screening.
- Considered at significant risk for suicide during the course of the study.
- Has a clinically significant abnormality on the screening examination that might
affect safety, study participation, or confound interpretation of study results.
- Participation in any clinical trial with an investigational drug or device within the
past month or concurrent to study participation.
- 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.
- History of positive screening urine test for drugs of abuse at screening: cocaine,
amphetamines, barbiturates, opiates.
- Current (or chronic) use of opiates.
- History of epilepsy.
- History of rTMS exposure.
- History of any implanted device or psychosurgery for depression.
- History of ECT intolerance.
- History of shrapnel or metal in the head or skull.
- "Low Treatment Refractory" using the Maudsley staging method.
- History of cardiovascular disease or cardiac event.
- History of OCD.
- History of autism spectrum disorder.
- History of intractable migraine
- History of independent sleep disorder.
Intervention(s):
device: Active TBS-DLPFC
device: Sham TBS-DLPFC
device: Open label TBS-DLPFC
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Romina Nejad, MSc
650-736-4850