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

Trial ID or NCT#

NCT04195308

Status

not recruiting iconNOT RECRUITING

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

Eligibility Criteria

Ages Eligible for Study: 22 Years to 80 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * 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.
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Investigator(s)

Nolan Williams
Nolan Williams
Deep brain stimulation specialist, Neuroimaging specialist, Psychiatrist
Associate Professor of Psychiatry and Behavioral Sciences (Major Laboratories & Clinical Translational Neurosciences Incubator) and, by courtesy, of Radiology (Neuroimaging and Neurointervention)

Contact us to find out if this trial is right for you.

Contact

Romina Nejad, MSc
650-736-4850

View on ClinicalTrials.gov