Note: This study is currently only recruiting patients in the hospital.
If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.
Are you currently depressed and taking an antidepressant but it is not working well for you?
This project is not recruiting.
Overview
What we are studying
Have you been feeling down or depressed? You will be asked to make a minimum of 7 in person visits to our clinic in Downtown Boston, with the possibility of making an additional 26 visits to the Charlestown Navy Yard Campus of MGH over the course of 12 weeks. You will also complete 8 phone visits. Your insurance may be billed for clinical and treatment visits. If you complete all parts of this study, you will be compensated $200 for your effort. We also validate your parking.
Are you at least 18 years old?
Are you currently taking an antidepressant medication that is not working?
If so, you may be eligible to participate at no cost to you in a research study at Massachusetts General Hospital (MGH).
The purpose of this research study is to compare the effect of augmenting an antidepressant with aripiprazole (common brand Abilify) or rTMS (commonly referred to as Repetitive transcranial magnetic stimulation) versus switching to venlafaxine XR (common brand Effexor) for participants who have tried an antidepressant in the past but has not helped their depression. You must already be on an antidepressant medication, but it isn’t working very well.
Why it is important
Treatment Resistant Depression (TRD), i.e. depression that does not respond well enough to standard antidepressant therapy, is by nature difficult to treat, and psychiatrists do not yet know how to best manage this condition. There is very little research-based evidence regarding whether it is better to add a second medication or other therapy to an underperforming antidepressant, or whether to switch to a new antidepressant altogether. Despite frequent use of these strategies in psychiatric practice, we are not yet certain which of these approaches may be optimal for TRD. We aim to address this important unanswered question in this new, groundbreaking study.
What we hope to accomplish
The treatments used in this study are commonly prescribed and easily obtainable for patients from all backgrounds. They are either generic (i.e. venlafaxine XR, aripiprazole), or covered by Medicare and commercial insurance (rTMS). Because of their high accessibility for depressed patients in general, the results of the study could have tremendous impact on how psychiatrists manage treatment resistant depression worldwide. Hence, our study will provide novel and highly influential guidance in managing one of the most common, disabling, and therapeutically challenging medical conditions, and will help resolve the uncertainty about treatment choice that TRD patients and their clinicians must face every day
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Principal Investigator
Who can participate
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.
Who cannot participate
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 (see Appendix 1), 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.
What you may be asked to do
You will receive aripiprazole (common brand Abilify) or venlafaxine XR (common brand Effexor) or will be assigned to complete rTMS (commonly referred to as Repetitive transcranial magnetic stimulation) sessions.
Project activities may include:
- Survey
- Blood draw
- Medication
- Office visit
Estimated Time Commitment
7 visits over 12 weeks
What You May Get
You will be compensated up to $200
Location
MGH- Massachusetts General Hospital
One Bowdoin Square, 6th Floor, Boston, MA 02114
Travel
- Accessible by public transportation
- Parking reimbursed
Travel and Parking Details
Additional Information
Study Phase
Phase 4: This project studies a drug or treatment that has already been approved by the FDA and studied in both healthy volunteers and participants with specific diseases or conditions. It will gather more information about long term safety and will help to understand how the drug or treatment can be most effective.
Funding Source
- Foundation