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.

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