Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non-responders With TRD

  • STATUS
    Recruiting
  • End date
    Jan 10, 2022
  • participants needed
    639
  • sponsor
    Massachusetts General Hospital
Updated on 10 September 2020
Investigator
Yurerkis Montas, MA
Primary Contact
Shepperd Pratt Health System, University of Maryland School of Medicine (7.6 mi away) Contact
+21 other location

Summary

This is a multi-site, randomized, open-label, effectiveness trial comparing three treatment arms for Major Depressive Disorder (MDD) patients with TRD who are currently on ongoing, stable and adequate antidepressant therapy (ADT). Adequate ADT is defined as a therapeutically sufficient dose for a sufficient treatment period, which would be expected to be effective as listed in the MGH Antidepressant Treatment Response Questionnaire (ATRQ). Patients will be randomized in a 1:1:1 fashion to one of three open-label treatment arms: a) aripiprazole augmentation, b) rTMS augmentation, and c) switching to venlafaxine XR or Duloxetine.

Details
Treatment Aripiprazole, venlafaxine XR, Repetitive Transcranial Magnetic Stimulation (rTMS)
Clinical Study IdentifierNCT02977299
SponsorMassachusetts General Hospital
Last Modified on10 September 2020

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Eligibility

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Inclusion Criteria

Is your age between 18 yrs and 80 yrs?
Gender: Male or Female
Do you have Treatment Resistant Major Depressive Disorder?
women and men ages 18-80
with MDD, of at least 12 weeks duration, according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria confirmed by the Mini International Neuropsychiatric Interview (MINI; Sheehan et al, 1998)
have a Montgomery-Asberg Depression Rating Scale (MADRS - Montgomery and Asberg, 1979) score of at least 20 at screen and baseline as assessed by site clinicians
meet criteria for TRD during the current major depressive episode documented in the MGH Antidepressant Treatment History Questionnaire (ATRQ) (Chandler et al., 2010), which will be defined as being non-responders (less than 50% of symptom improvement) to two or more depression treatment trials of adequate dose and duration as defined by the MGH ATRQ
are currently on an antidepressant of adequate dose (as defined by the MGH ATRQ) and duration (at least 8 weeks), with the antidepressant dose being stable over the past four weeks, and with documented (in the MGH ATRQ) non-response (less than 50% improvement) to the current antidepressant
Patients who have passed the MGH CTNI remote assessment, with documentation provided to sites by MGH CTNI

Exclusion Criteria

pregnant or breastfeeding women, women of childbearing potential who are not using an accepted means of birth control, or women with a positive urine pregnancy test
patients who have received treatment with rTMS, aripiprazole, electroconvulsive therapy (ECT), or venlafaxine during the current episode
patients who express an objection to receiving treatment with at least one of the three treatment arms of our study
patients with any history of bipolar disorder or psychosis (diagnosed by MINI)
patients with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI)
patients with suicidal ideation of the degree that, in the opinion of the evaluating clinician, participation in the study would place them at significantly increased risk of suicide
patients with unstable medical issues of such degree that, in the opinion of the evaluating clinician, participation in the study would place them at significant risk of a serious adverse event, or patients with a screening hemoglobin A1c level greater than 7.5%, or patients with epilepsy, dementia, Parkinson's disease, or Huntington's Disease
patients who have received treatment with vagus nerve stimulation (VNS)
patients who have not responded to more than five FDA-approved antidepressant treatment trials of adequate dose and duration during the current episode, or who did not respond to ECT in previous episodes
patients on excluded medications
patients with a positive urine screen drug test for a substance for which they do not have a valid prescription for a valid medical reason
patients with currently abnormal thyroid function tests
patients who have received at least one dose of a monoamine oxidase inhibitor (MAOI) four weeks or less prior, and
for patients on concomitant psychotropic agents (anticonvulsants, benzodiazepines, hypnotics, opiates, triiodothyronine (T3), modafinil, psychostimulants, buspirone, melatonin, omega-3 fatty acids, folate, l-methylfolate, s-adenosyl methionine, lithium) not on the same dose for at least four weeks prior to study entry or who do not agree to continue at the same dose during the acute phase of the study
Patients who do not meet safety criteria for TMS: history of seizures, cardiac pacemaker, DBS or VNS, brain aneurism clips or other metallic implants in the intracranial space
Also excluded is an individual who has received any administration of ketamine in the current episode for the treatment of depression
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