TEEN MENTAL HEALTH RESEARCH
Ketamine Study

ABOUT the study

This study is testing an investigational medication called ketamine for severe depression in adolescents who have not gotten better with more standard treatments. Ketamine is a medication that is used in anesthesia. The study protocol involves 6 intravenous (I.V.) infusions of ketamine, using a "sub-anesthetic" dose (lower than that used for medical procedures). We are also examining the neurobiological mechanisms response to ketamine using Magnetic Resonance Imaging (MRI) and blood tests.

Eligibility

INCLUSION CRITERIA:
  • Between the ages of 12-18 years old
  • Recurrent Major Depressive Disorder (MDD) without psychotic features
  • The current episode of depression is resistant to depression (i.e. failure to improve with at least 2 different anti-depressant medications)
  • Current anti-depressant medications cannot have changed for 2 months prior to study participation
EXCLUSION CRITERIA:
  • Inability to speak English (Parent/guardian inability to speak English for participants under 18 years old)
  • History of Mental Retardation or Autism Spectrum Disorder
  • Current or lifetime diagnosis of Schizophrenia, Schizoaffective Disorder, Psychosis Not Otherwise Specified (NOS)
  • Diagnosis of seizure or other neurological disorders
  • Comorbid diagnosis of substance abuse or dependence within 6 months of assessment
  • Clinically unstable medical illness
  • Current use of barbituates, narcotics, or non-benzodiazepine hypnotics at doses higher than Zolpidem 10mg or equivalent for insomnia
  • Pregnancy
  • Inability to undergo an MRI scan
  • Family history notable for having at least 1 first-degree relative with Schizophrenia, Schizoaffective Disorder, or Psychosis NOS

STUDY VISITS

INTERVIEW & CLINICAL ASSESSMENT:
​For the first visit, you will be asked to come to the Ambulatory Research Center (ARC) at the Fairview Riverside Hospital for a clinical assessment. We will ask you about to complete a  medical history and your symptoms. Participants under the age of 18 will have a parent/guardian participate in a separate interview. The participant and parent/guardian (if applicable) will also complete a number of questionnaires. We will also conduct a brief physical examination. This visit could take up to 4 hours.

MAGNETIC RESONANCE IMAGING (MRI) VISITS:
Both before you begin the ketamine infusions and after you have completed them, you will be asked to come to the Center for Magnetic Resonance Research (CMRR) for a brain scan. You will be asked to lie in the scanner while the machine takes pictures of your brain. While you are in the scanner, you will be doing things like listening to music, resting, and completing a task that involves looking at faces with words printed over them and assessing whether the word is positive or negative. These visits will take 2 hours each.

KETAMINE INFUSIONS:
You will receive six I.V. infusions at the Journey Clinic located in the East Building of the Fairview Riverside hospital over a 2 week period on a Monday-Wednesday-Friday schedule. Each infusion will happen over 40 minutes and then you will be observed for an additional 2 hours. These appointments will take a total of 3-4 hours each.

BLOOD DRAWS:
You will be asked to give blood 3 times over the course of this study - before and after your first ketamine infusion and after your last ketamine infusion. Approximately 1.25 Tablespoons will be taken from the IV that has been placed for the infusions for each blood draw. This blood will be marked with only a number and sent to the Mayo Clinic for analyses. 

POST KETAMINE ASSESSMENT:
After you have completed the Ketamine Infusions you will be asked to return to the ARC to have your depressive symptoms assessed again. This appointment will take 1 hour.

FOLLOW-UP VISITS:
Participants who have responded to treatment will be asked to come back weekly for 6 weeks. If you live very far away, we can arrange to conduct these visits with videoconference. We will follow up with all participants after 6 months.

COMPENSATION

​You will be compensated for some of the visits in the study. You will receive a total of $240 if you complete all portions of the study. If you only complete some portions of the study, you will be compensated for each portion you do complete. Parking costs will be reimbursed.