ASCERTAIN DEPRESSION STUDY


Augmentation versus Switch: Comparative Effectiveness Research Trial for Antidepressant Incomplete and Non- responders with Treatment Resistant Depression

Major Depressive Disorder (MDD) is a very common medical condition that can have many causes, such as life experiences, genetics, and changes in the way the body and brain function. MDD is often treated with antidepressant medication, however, 30-40% of patients do not respond to their first medication treatment. We are doing this study to compare the effectiveness of three different treatment options: the addition of Aripiprazole, the addition of repetitive transcranial magnetic stimulation (rTMS), and changing your current antidepressant to Venlafaxine.

In this study, we will be collecting detailed information about your psychiatric history, depression symptoms, and a range of personality, cognitive, and lifestyle factors, while you partake in one of three possible treatment interventions. We will also ask you to undergo a screening blood draw on your first visit and measure your vital signs (blood pressure, pulse, and weight) at every visit. Further, on three visits we will ask you to complete an electroencephalogram (EEG).

Details

Participants will be randomly assigned to one of three treatment options for major depressive disorder: rTMS, Aripiprazole, and Venlafaxine XR. All of these treatments have been approved as a treatment for major depressive disorder by Health Canada.

Repetitive Transcranial Magnetic Stimulation (rTMS) is a treatment that involves stimulating certain areas of the brain with magnetic field pulses. Over time, the magnetic field pulses can gradually change the activity level of the stimulated brain region and help symptoms of depression. The device used in this study has been approved by Health Canada for therapeutic use since 2002. If assigned to rTMS, you will be asked to continue your current medication in addition to receiving daily rTMS.

Venlafaxine (Effexor) is a serotonin-norepinephrine reuptake inhibitor (SNRI) commonly used in the treatment of depression. It increases the concentration of the neurotransmitters serotonin and norepinephrine in the brain. For purposes of the study, if assigned to Venlafaxine, you will be asked to discontinue your current antidepressant and to switch to Venlafaxine. The doctor will optimize the required dose of Venlafaxine XR; dosing may range from 37.5mg to 375mg.

Aripiprazole (Abilify) is an atypical antipsychotic used as an add-on treatment for depression. Aripiprazole increases concentration of certain subtypes of dopamine as well as serotonin, two neurotransmitters associated with mood. If assigned to Aripiprazole, you will be instructed to continue your current medications in addition to commencing Aripiprazole. The doctor will optimize the required dose of Aripiprazole; dosing may range from 2mg to 20mg.

The Team

The study is being conducted by several different researchers at hospitals in Canada and the United States. The primary investigator in Vancouver is Dr. Fidel Vila-Rodriguez, director of the NINET lab at UBC Hospital.

Eligibility

You may be eligible if:

  • You are 18 to 80 years of age.
  • You are experiencing a major depressive episode in Major Depressive Disorder.
  • You failed to achieve a successful response to at least one antidepressant
  • You are currently taking an antidepressant at adequate dose and have not had a satisfactory response.
  • You are willing to partake in any of the three treatment options, blood draws, and brain scans/measurements.
  • If considering, please inform us:

  • If you are pregnant, or thinking of becoming pregnant
  • Of all medications that you are taking, including herbal supplements and over the counter medication. If possible bring a list of medications, including how often you take them and the dosages.
  • If you have had any past injuries or surgeries, or other physical or mental health problems, including:
    • Aneurysm clips or coils
    • Stents in the neck or brain
    • Implanted stimulators
    • Cardiac pacemakers or implantable cardioverter defibrillator (ICD)
    • Metallic implants in your ears and eyes, (ex: dental implants, cochlear implants)
    • Hearing Aid
    • Shrapnel or bullet fragments in or near the head
    • Facial tattoos with metallic or magnetic-sensitive ink
    • Other metal devices or object implanted in or near the head
    • History of seizures and/or family history of seizures

    Commonly asked questions about the study:

    Q: Will my treatment/healthcare records be kept confidential?
    A: Your confidentiality will be respected. No information or records that disclose your identity will be published without consent, nor will any of your information or records that disclose your identity be removed or released without your consent, unless required by law.

    Q: How much will treatments cost?
    A: Nothing. TMS treatments can cost up to $250 per session, however, when participating in a research study, you will receive treatment for free. We will also cover the cost of the Venlafaxine or Aripiprazole for the duration of the study.

    Q: What is the benefit of participating in the study?
    A: You may find that your symptoms improve, however this is not guaranteed. Information gathered from this study may help other people undergoing TMS or medication treatments for mood disorders in the future. In general, we hope that the information learnt from this study can be used in the future to benefit other people with depression and related disorders.

    Treatment Schedule

    If assigned to the rTMS condition, you will receive treatment every weekday for the first five weeks and twice a week for week six, seven, and eight. Each TMS session will be about 40 minutes in duration. If assigned to the Aripiprazole or Venlafaxine XR condition, you will have weekly check-ins with the study psychiatrist where you will review your dose and any side effects you may be experiencing.

    Contact Information:

    For more details regarding the study, or to discuss enrolment, please contact us at 604-827-1361 or email ninet.lab@ubc.ca.