A Randomized Double-Blind Multi-Center Open-Label Effectiveness Trial of Antidepressant Augmentation in Patients with Treatment Resistant Depression

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Depression
  • Age: Between 18 - 80 Years
  • Gender: Male or Female
  • Other Inclusion Criteria:
    1. Subjects who are at least 18 years old
    2. Subjects with major depressive disorder (MDD), of at least 12 weeks duration,
    3. Subjects 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. Subjects meet criteria for TRD (i.e., not improving with at least 2 treatments during the current major depressive episode, as documented in the MGH Antidepressant Treatment History Questionnaire, ATRQ)
    5. Subjects who 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. Subjects who have passed the MGH CTNI remote assessment, with documentation provided to sites by MGH CTNI.

You may not be eligible for this study if the following are true:

    1. Subjects who are pregnant or breastfeeding.
    2. Subjects who have received treatment with rTMS, atypical antipsychotic agents, electroconvulsive therapy (ECT), or venlafaxine and duloxetine during the current episode
    3. Subjects who express an objection to receiving treatment with at least one of the three treatment arms of our study
    4. Subjects with any history of bipolar disorder or psychosis (diagnosed by MINI)
    5. Subjects with active alcohol or substance abuse disorders within the past 6 months (diagnosed by MINI)
    6. Subjects 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. Subjects 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
    8. Subjects who have received treatment with vagus nerve stimulation (VNS)
    9. Subjects 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. Subjects on medications not permitted as per the protocol
    11. Subjects 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. Subjects with currently abnormal thyroid function tests
    13. Subjects who have received at least one dose of a monoamine oxidase inhibitor (MAOI) four weeks or less prior
    14. Subjects who are on concomitant psychotropic agents



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