18 Day Protocol for the Ketamine Clinical Study

  • Day 1   A Research Assistant RA) will come to your home to:
    • Administer to your child 3 exercises which are designed to test his cognitive abilities.  This will take approximately 1 hour.
    • Instruct you as to how to fill out two daily reports.  Instruction will take approximately ½ hour.  You will record this information into a special study website on your computer.  If you do not a have a computer, you may use the study computer which will stay in your home.  The daily reports will require approximately 15-20 minutes of your time each night.
    • Administer to you 2 behavioral questionnaires. This will take approximately ½ hour.
  • Day 2   The RA will call you to administer 3 more behavioral questionnaires.  This phone interview will take approximately 1 hour.
  • Days 3, 4 and 5   The RA will check in with you by phone to make sure you are able to fill out the daily charts comfortably.  Your child’s presence will not be required.  The RA will continue to monitor you submissions electronically and will contact you if necessary.
  • Days 7, 10, 13 and 16   Dosing days. The nurse will come to your home in the morning to administer the drug/placebo. He or she will:
    • Assess your child’s health to make sure that administration can continue.
    • Perform a nasal cleansing which consists of irrigation of the nasal sinuses.
    • Administer the drug or placebo via a nasal spray.
    • Monitor your child’s safety by checking vital signs over a two hour period and completing several safety checklists.

During this time:

– Your child may engage in quiet activity although he will be needed to respond to questions and have his vitals checked periodically.

– The Principal Investigator may observe your child via a Skype camera on the laptop.

Approximately one hour post dose, your child should be able to resume normal activity.

  • Days 9, 12 and 15  On the evening prior to the 2nd, 3rd and 4th administrations, the RA will call you to go over two brief questionnaires.  This should take approximately 15-30 minutes.
  • Day 18   The RA will come to your home and administer to you and your child the same series of tests and questionnaires that were given on Days 1 and 2.
  • Day 90   A follow-up questionnaire will be completed by phone interview

At various points throughout the study, the Principal Investigator, Dr. Demitri Papolos, may contact you.  You will be given a contact number for Dr. Papolos which will be available to you 24/7.

 

Optional: We would like to collect data which measures very sensitive information about body temperature. A special ambulatory monitor has been developed for this. While this is not a required part of the study design, we hope that at least 10 families will choose to have their child wear the monitor for 2 days of the study. If you choose to do this, then the following would be added to the protocol:

  • Days 6 & 15 The nurse will come to your home in the evening and afternoon respectively,to place sensors on your child that will record activity and temperature. To accomplish this:
    • Sensor pads will be adhered to your child’s forehead, arms and trunk. Sensor ear plugs will also be used.
    • Leads from all of the sensors will attach to a monitor worn in a fanny-pack

It will take approximately 1 hour to set up the monitor and sensors.  Your child can wear pajamas over the sensors and go to bed at his regular time.  The monitor and sensors will be worn until 2 hours after the dose of drug or placebo is given on the next day.

The nurse will also need to measure your child’s response to thermal challenges.  To do this, after the sensors and monitor are in place, a temperature-sensitive patch will be placed on one forearm of your child. The other forearm will be immersed in mildly warm water for two minutes.  This test will take approximately 15 minutes.

If you choose to allow us to gather the thermoregulatory data, then on Days 7 and 16, when the nurse visits you, your child will still be wearing the sensors and monitor.  The nurse will repeat the thermal challenge both before and after the dose is given.  She will remove the sensors and monitor 2 hours after the dose administration.

For a calendar view of this protocol, click Calendar of protocol flow.

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