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Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort (SAINT-TRD)

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ClinicalTrials.gov Identifier: NCT03240692
Recruitment Status : Completed
First Posted : August 7, 2017
Last Update Posted : October 20, 2021
Sponsor:
Collaborator:
Schatzberg, Alan, M.D.
Information provided by (Responsible Party):
Nolan R, Stanford University

Tracking Information
First Submitted Date  ICMJE April 23, 2016
First Posted Date  ICMJE August 7, 2017
Last Update Posted Date October 20, 2021
Actual Study Start Date  ICMJE May 1, 2017
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
Percent change in the Montgomery Asberg Depression Rating Scale (MADRS) score from pre-treatment to 1-month [ Time Frame: Pre-treatment, 1-month post treatment. ]
A ten item diagnostic questionnaire used to measure the severity of depressive syptoms in patients with mood disorders.
Original Primary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
Change from baseline functional connectivity in immediate post-treatment [ Time Frame: Pre-treatment, immediate post-treatment ]
Functional connectivity of subcallosal cingulate to the default mode network and within the default mode network.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 25, 2019)
  • Percent change in the Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Pre-treatment, immediately post-treatment, 4 weeks post-treatment ]
    A suicidal ideation rating scale created by researchers at Columbia University.
  • Percent change in the Hamilton Rating Scale for Depression (HAM-6) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks, 3 weeks and 4 weeks post-treatment, and every 2 weeks for 26 weeks post-treatment ]
    A 6 item questionnaire used to score the severity of depression.
  • Percent change in the Hamilton Rating Scale for Depression (HAM-17) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks post-treatment ]
    A provider administered questionnaire used to assess remission and recovery from depression.
  • Change from baseline functional connectivity to 1-month post-treatment [ Time Frame: Pre-treatment, immediately post-treatment, 1-month post-treatment ]
    We will assess change in resting state fMRI functional connectivity of the subcallosal cingulate to the default mode network and within the default mode network.
  • Percent change in the Beck Depression Inventory (BDI-II) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks, 3 weeks and 4 weeks post-treatment, and every 2 weeks for 26 weeks post-treatment ]
    Self-report measure of depressive symptoms
  • Percent change in the Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: 2 weeks, 3 weeks, 4 weeks, 6 weeks and 8 weeks post-treatment ]
    A ten item diagnostic questionnaire used to measure the severity of depressive syptoms in patients with mood disorders.
  • Change from baseline functional connectivity to immediate post-treatment [ Time Frame: Pre-treatment, 1-month post treatment. ]
    Functional connectivity of subcallosal cingulate to the default mode network and within the default mode network.
Original Secondary Outcome Measures  ICMJE
 (submitted: August 1, 2017)
  • Montgomery Asberg Depression Rating Scale (MADRS) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A ten item diagnostic questionnaire used to measure the severity of depressive episodes in patients with mood disorders.
  • Columbia Suicide Severity Rating Scale (C-SSRS) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A suicidal ideation rating scale created by researchers at Columbia University.
  • Hamilton Rating Scale for Depression (HAM-6) [ Time Frame: Pre-treatment, immediately post-treatment, follow-up every 2 weeks for 6 months by telephone ]
    A 6 item questionnaire used to score the severity of depression.
  • Hamilton Rating Scale for Depression (HAM-21) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    A provider administered questionnaire used to assess remission and recovery from depression.
Current Other Pre-specified Outcome Measures
 (submitted: March 30, 2019)
A neuropsychological test battery testing cognitive abilities [ Time Frame: Pre-treatment, immediately post-treatment and 4 weeks post-treatment ]
The Hopkins Verbal Learning Test - Revised (HVLT-DR), the Brief Visuospatial Memory Test - Revised (BVMT-DR), Digit Span test and various tests from the Delis Kaplan Executive Function System (DKEFS) will be used to assess possible cognitive side-effects.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression: OL Cohort
Official Title  ICMJE Stanford Accelerated Intelligent Neuromodulation Therapy for Treatment-Resistant Depression (SAINT-TRD)
Brief Summary This study evaluates an accelerated schedule of theta-burst stimulation using a transcranial magnetic stimulation device for treatment-resistant depression. In this open label study, all participants will receive accelerated theta-burst stimulation.
Detailed Description Repetitive transcranial magnetic stimulation (rTMS) is an established technology as therapy for treatment-resistant depression. The approved method for treatment is 10Hz stimulation for 40 minutes over the left dorsolateral prefrontal cortex (L-DLPFC) for a 6 week treatment course. This methodology has been successful for many people with treatment-resistant depression. One of the limitations of this approach is the long duration of the treatment course (approximately a 6 weeks per treatment course). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment course time with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment. This study will also look at the change in neuroimaging biomarkers associated with this treatment.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Treatment Resistant Depression
Intervention  ICMJE Device: Accelerated theta-burst stimulation treatment

All participants will receive intermittent theta-burst stimulation (iTBS) to the left dorsal lateral prefrontal cortex (L-DLPFC). The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold (adjusted for cortical depth).

Stimulation will be delivered to L-DLPFC using the Magventure Magpro X100 and/or the NextStim TMS system.

Study Arms  ICMJE Experimental: Accelerated theta burst treatment
All participants will receive theta-burst TMS.
Intervention: Device: Accelerated theta-burst stimulation treatment
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 20, 2017)
30
Original Estimated Enrollment  ICMJE
 (submitted: August 1, 2017)
5
Actual Study Completion Date  ICMJE March 3, 2020
Actual Primary Completion Date December 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 an antidepressant therapy but the medication must remain stable throughout study enrollment.
  • Participants may also have a history of intolerance to antidepressant medications. These patients with the intolerance history will not be required to be currently taking an antidepressant medication.
  • 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.
  • 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.
  • History of ECT intolerance is permitted.

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.
  • Total HAMD 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.
  • 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.
  • 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.
  • Positive screening on the urine test for drugs of abuse at screening: cocaine, amphetamines, barbiturates, opiates.
  • Current (or chronic) use of opiates.
  • History of epilepsy.
  • History of shrapnel or metal in the head or skull.
  • History of cardiovascular disease or cardiac event.
  • History of OCD.
  • History of autism spectrum disorder.
  • History of rTMS exposure
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03240692
Other Study ID Numbers  ICMJE 33797
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: clintrials.gov
Responsible Party Nolan R, Stanford University
Study Sponsor  ICMJE Stanford University
Collaborators  ICMJE Schatzberg, Alan, M.D.
Investigators  ICMJE
Principal Investigator: Nolan Williams, MD Stanford University
PRS Account Stanford University
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP