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Switching versus augmentation in treatment-resistant depression
Investigator (PI): Papakostas, George
Performing Organization (PO): (Current): Massachusetts General Hospital, Department of Psychiatry, Depression Clinical and Research Program / (617) 724-5600
Supporting Agency (SA): Patient-Centered Outcomes Research Institute (PCORI)
Initial Year: 2016
Final Year: 2022
Record Source/Award ID: PCORI/TRD-1511-33227
Funding: Total Award Amount: $14,210,781
Award Type: Contract
Award Information: PCORI: More information and project results (when completed)
Abstract: Major depression causes significant illness and can even be fatal. It affects over 30 million adults in the United States, but more than one-third of patients with major depression fail to recover despite treatment with multiple medications. These patients are then considered to have treatment-resistant depression (TRD). Despite the fact that TRD is common and disabling, there have been few rigorous clinical trials on this condition. This leaves both patients and their providers with great uncertainty regarding which treatments might help a patient with TRD. This study would help provide answers to the question of how a particular patient with TRD should be treated for the best chance of recovery. The study will help people choose between therapeutic options by providing the results of a clinical trial that compares the effectiveness of three different treatments. Each of these treatments is approved by the Food and Drug Administration as being safe and effective for treating major depression. The question addressed would be whether positive results and undesirable side effects are different when patients with TRD are treated by having their current ineffective antidepressant 1) supplemented with repetitive transcranial magnetic stimulation (rTMS), 2) supplemented with the antidepressant medication aripiprazole (Abilify[R]), or 3) switched to the antidepressant venlafaxine (Effexor[R]). All three interventions have ample evidence for their efficacy in major depression and TRD but have never been compared against each other. The treatment rTMS involves patients receiving magnetic stimulation by a device placed on their heads. This treatment has been thoroughly tested and is safe, does not involve anesthesia, and has very few side effects. The goal of the study is to compare the effectiveness, safety, and side effects of the interventions. For each patient in the trial, one of the three treatments will be randomly selected. The work will be conducted at 10 academic medical centers located around the country. The distribution of the medical centers ensures racial, ethnic, and socioeconomic diversity among the patient participants. Patients eligible for this study will have major depression that has lasted at least eight weeks and that has not been helped by at least two different antidepressant medications. In the study, patients will have initial visits for confirming they are eligible for the trial. If they are eligible, they will have another baseline visit, then weekly visits for a total of eight weeks. Participants' levels of depression during the eight weeks will be monitored by telephone. At the conclusion of the clinical trial part of this study--and in order to collect long-term, real-world data--study participants will periodically (monthly for one year) complete online self-rating questionnaires, which measure their depression symptoms, functioning at work and home, and quality of life.
MeSH Terms:
  • Antidepressive Agents /*therapeutic use
  • Aripiprazole /*therapeutic use
  • Clinical Trials as Topic
  • Comparative Effectiveness Research
  • Data Collection
  • Depressive Disorder, Treatment-Resistant /*drug therapy
  • Follow-Up Studies
  • Humans
  • Patient Safety
  • Quality of Life
  • Social Class
  • Surveys and Questionnaires
  • Transcranial Magnetic Stimulation
  • United States
  • United States Food and Drug Administration
  • Venlafaxine Hydrochloride /*therapeutic use
Country: United States
State: Massachusetts
Zip Code: 02114
UI: 20164154
Project Status: Ongoing
Record History: ('2017: Project extended to 2022.',)