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Accelerated Theta Burst Stimulation in Treatment-Resistant Depression (aTBS)

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ClinicalTrials.gov Identifier: NCT03240692
Recruitment Status : Enrolling by invitation
First Posted : August 7, 2017
Last Update Posted : April 16, 2019
Sponsor:
Collaborator:
Schatzberg, Alan, M.D.
Information provided by (Responsible Party):
Nolan R, Stanford University

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.

Condition or disease Intervention/treatment Phase
Treatment Resistant Depression Device: Accelerated theta burst treatment Not Applicable

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). This methodology has been very successful in real world situations. The limitations of this approach include the duration of the treatment (approximately 40 minutes per treatment session). Recently, researchers have aggressively pursued modifying the treatment parameters to reduce treatment times with some preliminary success. This study intends to further modify the parameters to create a more rapid form of the treatment and look at the change in neuroimaging biomarkers.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerated Theta Burst Stimulation in Treatment-Resistant Depression
Actual Study Start Date : May 1, 2017
Estimated Primary Completion Date : May 30, 2020
Estimated Study Completion Date : May 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Accelerated theta burst treatment
All participants will receive theta-burst TMS.
Device: Accelerated theta burst treatment

All participants will receive iTBS (intermittent theta burst stimulation) to the left DLPFC. The L-DLPFC will be targeted utilizing the Localite neuronavigation system. Stimulation intensity will be standardized at 90% of resting motor threshold adjust to the skull to cortical surface distance.

Stimulation will be delivered to L-DLPFC using the MagPRo stimulator.





Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. Hamilton Rating Scale for Depression (HAM-17) [ 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.

  4. Change from baseline functional connectivity in 4 weeks post-treatment [ Time Frame: Pre-treatment, 4 weeks 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.

  5. Beck Depression Inventory (BDI-II) [ Time Frame: Pre-treatment, immediately post-treatment, 2 weeks post-treatment, 4 weeks post-treatment ]
    Self-report measure of depressive symptoms


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female, 18 to 80 years of age.
  • Able to provide informed consent.
  • Diagnosed with Major Depressive Disorder (MDD) or Bipolar Affective Disorder 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 HAMD21 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 rTMS failure with FDA approved rTMS parameters is permitted.
  • History of ECT failure or 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.
  • Female with a positive pregnancy test at participation.
  • Total HAMD 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.
  • 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 shrapnel or metal in the head or skull.
  • History of cardiovascular disease or cardiac event.
  • History of OCD.
  • History of autism spectrum disorder.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03240692


Locations
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United States, California
Nolan Williams, MD
Palo Alto, California, United States, 94305
Sponsors and Collaborators
Stanford University
Schatzberg, Alan, M.D.
Investigators
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Principal Investigator: Nolan Williams, MD Stanford University

Publications:

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Responsible Party: Nolan R, Instructor of Psychiatry & Behavioral Sciences, Director of the Brain Stimulation Laboratory at Stanford University School of Medicine, Stanford University
ClinicalTrials.gov Identifier: NCT03240692     History of Changes
Other Study ID Numbers: 33797
First Posted: August 7, 2017    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: clintrials.gov

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Nolan R, Stanford University:
Major Depressive Disorder
Treatment Resistant Depression
Transcranial Magnetic Stimulation (TMS)
Theta Burst

Additional relevant MeSH terms:
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Depression
Depressive Disorder
Depressive Disorder, Treatment-Resistant
Behavioral Symptoms
Mood Disorders
Mental Disorders