Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Treatment Resistant Depression
- Sponsor
- Stanford University
- Enrollment
- 30
- Locations
- 1
- Primary Endpoint
- Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
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.
Detailed Description
Repetitive transcranial magnetic stimulation (rTMS) is an established therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 min over the left dorsolateral prefrontal cortex (L-DLPFC). This methodology has been effective in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session, 5 days per week, for 4-8 weeks). Recently, researchers have pursued modifying the treatment parameters to reduce treatment times with some preliminary successes. This study aims to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.
Investigators
Nolan R
Assistaant Professor, Psychiatry & Behavioral Sciences, Stanford University School of Medicine
Stanford University
Eligibility Criteria
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.
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.
Outcomes
Primary Outcomes
Percentage Change in Montgomery-Åsberg Depression Rating Scale (MADRS) Score From Pre-treatment to 1-month Post-treatment.
Time Frame: Pretreatment (baseline), 1-month post-treatment
A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.The MADRS has an overall score range from 0-60, with higher scores corresponding to higher levels of depression.
Secondary Outcomes
- Percentage Change in the Hamilton Rating Scale for Depression (HAMD-17)(Pre-treatment (baseline) to immediately post-treatment (day 8).)
- Change in the Columbia Suicide Severity Rating Scale (C-SSRS) Score(Pretreatment (baseline) to immediately post-treatment (day 8).)
- Change in the Hamilton Rating Scale for Depression (HAM-6) Score(Baseline (pre-treatment) and at 1-month post-treatment)
- Change From Baseline Functional Connectivity to Immediate Post-treatment(Pretreatment (baseline) to immediately post-treatment (day 8).)
- Change in Baseline Heart Rate Variability to Immediate Post-treatment(Pretreatment to immediate post-treatment (day 8).)
- Change From Baseline Functional Connectivity to 1-month Post-treatment(Pretreatment (baseline) to 1-month post-treatment)
- Change in Baseline Heart Rate Variability to 1-month Post-treatment(Pretreatment to 1-month post-treatment)