Trial Search Results

SAINT for Treatment of Preoperative Depression to Reduce Opioid Use Following Arthroplasty

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.

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 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.

Ages Eligible for Study

22 Years - 80 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
650-736-4850
Not Recruiting