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

Description

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.

Study Start Date

May, 01 2017

Estimated Completion Date

January 2022

Interventions

  • Drug: Aripiprazole
  • Device: Repetitive transcranial magnetic stimulation (rTMS)
  • Drug: Venlafaxine XR

Study ID

Massachusetts General Hospital -- 2015P002430

Status

Recruiting

Trial ID

NCT02977299

Study Type

Interventional

Trial Phase

Phase 4

Enrollment Quota

639

Sponsor

Massachusetts General Hospital

Inclusion Criteria

    1. women and men ages 18-80, 2. 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), 3. 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, 4. 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, 5. 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. 6. Patients who have passed the MGH CTNI remote assessment, with documentation provided to sites by MGH CTNI.

Exclusion Criteria

    1. 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, 2. patients who have received treatment with rTMS, aripiprazole, electroconvulsive therapy (ECT), or venlafaxine during the current episode, 3. patients who express an objection to receiving treatment with at least one of the three treatment arms of our study, 4. patients with any history of bipolar disorder or psychosis (diagnosed by MINI), 5. patients with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI), 6. 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, 7. 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, 8. patients who have received treatment with vagus nerve stimulation (VNS), 9. 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 10. patients on excluded medications, 11. 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, 12. patients with currently abnormal thyroid function tests, 13. patients who have received at least one dose of a monoamine oxidase inhibitor (MAOI) four weeks or less prior, and 14. 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. 15. 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. 16. Also excluded is an individual who has received any administration of ketamine in the current episode for the treatment of depression.

Gender

All

Ages

18 Years to 80 Years

Accepts Healthy Volunteers

No

Study Locations and Contact Information (35)

Study Location Distance Name Phone Email
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles David Mischoulon MD PhD 617-724-5198 dmischoulon@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles David Mischoulon MD PhD 617-724-5198 dmischoulon@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles David Mischoulon MD PhD 617-724-5198 dmischoulon@partners.org
Massachusetts General Hospital - Boston, Massachusetts 2.8 miles David Mischoulon MD PhD 617-724-5198 dmischoulon@partners.org
New York University - New York, New York 187.6 miles Dan Iosifescu MD None Dan.Iosifescu@nyumc.org
New York University - New York, New York 187.6 miles Dan Iosifescu MD None Dan.Iosifescu@nyumc.org
New York University - New York, New York 187.6 miles Dan Iosifescu MD None Dan.Iosifescu@nyumc.org
New York University - New York, New York 187.6 miles Dan Iosifescu MD None Dan.Iosifescu@nyumc.org
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Michael Thase MD None thase@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Michael Thase MD None thase@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Michael Thase MD None thase@mail.med.upenn.edu
University of Pennsylvania - Philadelphia, Pennsylvania 270.8 miles Michael Thase MD None thase@mail.med.upenn.edu
Emory University - Atlanta, Georgia 932.0 miles None None None
Emory University - Atlanta, Georgia 932.0 miles None None None
Emory University - Atlanta, Georgia 932.0 miles None None None
The University of Alabama School of Medicine - Birmingham, Alabama 1,052.1 miles Richard Shelton MD None rcshelton@uabmc.edu
The University of Alabama School of Medicine - Birmingham, Alabama 1,052.1 miles Richard Shelton MD None rcshelton@uabmc.edu
The University of Alabama School of Medicine - Birmingham, Alabama 1,052.1 miles Richard Shelton MD None rcshelton@uabmc.edu
The University of Alabama School of Medicine - Birmingham, Alabama 1,052.1 miles Richard Shelton MD None rcshelton@uabmc.edu
Kansas University School of Medicine - Wichita, Kansas 1,421.3 miles Matthew Macaluso DO None mmacaluso@kumc.edu
Kansas University School of Medicine - Wichita, Kansas 1,421.3 miles Matthew Macaluso DO None mmacaluso@kumc.edu
Kansas University School of Medicine - Wichita, Kansas 1,421.3 miles Matthew Macaluso DO None mmacaluso@kumc.edu
Kansas University School of Medicine - Wichita, Kansas 1,421.3 miles Matthew Macaluso DO None mmacaluso@kumc.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Manish Jha MD None Manish.Jha@UTSouthwestern.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Manish Jha MD None Manish.Jha@UTSouthwestern.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Manish Jha MD None Manish.Jha@UTSouthwestern.edu
University of Texas Southwestern Medical Center - Dallas, Texas 1,543.9 miles Manish Jha MD None Manish.Jha@UTSouthwestern.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Sanjay Mathew MD None sjmathew@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Sanjay Mathew MD None sjmathew@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Sanjay Mathew MD None sjmathew@bcm.edu
Baylor College of Medicine - Houston, Texas 1,609.9 miles Sanjay Mathew MD None sjmathew@bcm.edu
Stanford University - Stanford, California 2,694.5 miles Charles DeBattista MD None debattista@stanford.edu
Stanford University - Stanford, California 2,694.5 miles Charles DeBattista MD None debattista@stanford.edu
Stanford University - Stanford, California 2,694.5 miles Charles DeBattista MD None debattista@stanford.edu
Stanford University - Stanford, California 2,694.5 miles Charles DeBattista MD None debattista@stanford.edu

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