1. BENEFIT FROM STUDY
2. LOCATION OF STUDY
3. PARTICIPATION REQUIREMENTS
4. PARENTAL/GUARDIAN PARTICIPATION
6. OTHER MEDS
7. ENROLLMENT GUARANTEE
8. DURATION OF STUDY
9. NOTIFICATION OF PARTICIPATION
10. MISSING SCHOOL
11. CHANGE IN ACCEPTABLE STATUS
12. SCHEDULING CONFLICTS
14. WITHDRAWAL FROM APPLICATION
15. WITHDRAWAL FROM STUDY
16. TERMINATION FROM STUDY BY JBRF
17. OPPORTUNITY TO TRY KETAMINE AFTER PLACEBO
18. CHILD’S COMFORT
19. PAYMENT FOR PARTICIPATION
20. SAFETY OF KETAMINE
21. SIDE EFFECTS OF KETAMINE
22. ADVERSE EVENTS ASSOCIATED WITH KETAMINE OR PLACEBO
23. RESPONSE TO ADVERSE EVENTS
24. PRIVACY PROTECTION
1. How will this study BENEFIT my child? This is one of those good news/bad news situations. The good news is that, while outcomes of individual participation will vary…each family’s participation will bring us that much closer to completing the study. We view completion of the study as a critical component to any child’s (including your own) long-term access to this potentially effective treatment. Many families may benefit from this…but 60 families must help us to get there.
The bad news is that your child may not receive direct, immediate and continuing benefit from participation. As with most studies, your child has a 50% chance of getting placebo. Further, the study is only 18 days long and we cannot continue treating your child when it is over.
If your child does get ketamine and responds to it, you can bring this experience and information to your local pediatrician or psychiatrist and see if he/she is willing to continue management. If not, then at least you will have some hope to hold on to until the treatment becomes more accessible. (BTW, even if your child gets ketamine, he/she may not respond within the 4 administrations given in the study protocol. This doesn’t necessarily mean that he/she wouldn’t respond with a higher dose or with a longer treatment regimen.)
2. WHERE does the study take place? We MUST limit the geographical area of the study to within 50 miles of New York City and 50 miles of Westport, CT. While this area roughly corresponds to the New York Metropolitan Tri-State Area, it is actually a bit different. If you click here you will see the area that falls within our recruiting area.
If we are not able to recruit enough children from this area, we will move to open a hub in a state where we have identified a cluster of families interested in participation. That is one of the reasons we ask for you to give us your contact information on the web-site landing page. However, until that time, the geographical range is firm…we are simply not set up to do otherwise so please don’t ask.
3. What does PARTICIPATION require? The study lasts 18 days during which there will be 6 home visits and 5 evening phone calls.
4. How much PARENTAL/GUARDIAN PARTICIPATION will be required? Over the course of the 18 day protocol, the caregiver’s role is critical and mandatory. (see link from 2b above.) We need the same adult to respond to our questions throughout the study. Additionally, that same adult will record information and observations into a structured daily log.
- If you click here you will be brought to a full break down of what will happen on each day. The requirements of both you and your child are described there.
- If you click here you will be brought to a calendar version of the protocol.
- AGE: Your child MUST be between the ages of 6 and 12 to be enrolled in the study. We must be very strict about these criteria. Any deviations would undermine the accuracy and legitimacy of the results. If your child is almost 6, given the fact that the study will continue for a year or more, you could put in an application now knowing that we would not try to activate the case until his/her birthday. (Alternatively, you could submit the application later.)
While the age restrictions may be disheartening to those of you who would really like to participate, please understand that getting this study done right is the fastest way to get the results out there where they may help everybody.
i. MEDICAL: There are a few medical conditions which would make participation not possible. If you click here you will be brought to that list.
ii. MENTAL: We understand the difficult mental health conditions of children who would be enrolled in the study and are prepared to be supportive and patient. However it would not be possible, or good for your child, if we tried to conduct the case during a period of acute instability. If your child is in a period of frequent hospitalizations or is actively suicidal, we cannot enroll him or her. It would be best to wait until he or she enters a more even period of time.
i. REQUIRED: While your child may have a number of mental health diagnoses, he or she must at least qualify for bipolar I, II, or NOS. If you suspect, but don’t know, if your child has one of these types of bipolar disorder, programming embedded in the application will determine that eligibility. (You do not need to know if your child has FOH…nor is it necessary that he/she qualifies for the diagnosis. The application will determine that.)
ii. EXCLUDED: We will not be able to enroll any child who has a condition which makes him/her incapable of complying with the study requirements or unable to fully understand what is being asked of him/her. Other than that, the only mental health diagnosis which would disqualify your child from participation is schizophrenia as ketamine is contraindicated for this condition.
6. Would my child need to come off his/her OTHER MEDS? It is perfectly ok for your child to continue with most categories of meds. However, if your child uses any of the following, they will need to be eliminated one week before Day 1 of the study:
a. Lamotrigine (Lamictal)
- Tricyclics: most common are Anafranil (clomipramine) and Aventyl (nortriptyline)
- SSRI’s: most common are Celexa (citalopram), Lexapro (escitalopram), Luvox (fluvoxamine),Paxil (paroxetine), Prozac (fluoxetine), and Zoloft (sertraline)
- Atypical antidepressants: most common are Wellbutrin (bupropion), Effexor (venlafaxine)
7. If my child meets all the application criteria, will he/she be GUARANTEED ENROLLMENT in the study?
a. Once you complete the application, a message will pop up informing you as to whether your child did or did not meet all of the application criteria. Assuming that the application is accepted, it will be forwarded to the Principal Investigator for evaluation.
b. If the Principal Investigator determines that your child would be a good candidate for the study, then your child’s name gets put onto the Acceptable Candidate List. Either way, we will notify you.
c. Even after your child is placed on that list, there is no guarantee that we will call you to get started with the case. This depends upon the number of other children who are on the list ahead of your child and issues related to staff scheduling.
d. If we do call you to get started, (see #9 below) you will then need to obtain medical clearance (including some blood work, urinalysis, EKG, and a physical not more than 4 months old) from your child’s doctor. Once your child is cleared for the study, we will formally enroll him/her through an Informed Consent process.
8. What is the DURATION OF THE ENTIRE STUDY? Since we can only collect information from 4 children at a time, the study is likely to continue for approximately a year and a half.
9. If my child is put on the Acceptable Candidate List, WHEN ARE YOU LIKELY TO CALL US? There are a number of variables that will effect when we are able to try to move your child from the Acceptable Candidate List to active enrollment. Therefore, we could call on you at any time over the full duration of the study…That said, we will try to get to you as soon as possible. Upon receipt of your application, we will let you know where you stand on that list. We will also try to keep you updated as things move along.
If and when your child’s name is selected from the list, we will contact you six weeks in advance of the date that we would like to start. If you agree that the time works for you, you will then have three weeks in which to fulfill the requirements for medical clearance. Assuming that your child gets clearance, we will start app. 3 weeks later. The study staff assigned to your child’s case will contact you during this period to arrange daily scheduling.
10. Will my child need to STAY HOME FROM SCHOOL in order to participate? Administration of the drug/placebo must take place in the morning. This means that, if it is a school day rather than a weekend, your child will need to stay home for that. It is quite likely that your child will be able to return to school by 1PM. In addition to the morning time administrations, your child will need to take some neurocognitive tests on the first and last days of the study. These can be administered in the afternoon.
Some of the scheduling possibilities include one or two weekend days. While we will try to accommodate your preferences, we cannot promise it
11. Once my child is placed on the Acceptable Candidate List, is there anything that would CHANGE AN ACCEPTABLE STATUS? If any of the following occurs between the times that your child has been placed on the Acceptable Candidate List and when we call you, we may need to exclude him/her.
- Medicine change to a drug that is contraindicated to the study (if a change is needed…please put your child’s immediate needs ahead of the study!)
- Change of weight that puts him/her outside of acceptable weight range (44-220lbs)
- Ages out prior to enrollment
- Development of any of the medical conditions described as exclusionary
If your child has already been placed on the list but is in a fragile period when we call, we will not be able to enroll your child at that time. We will ask you to notify us when things have settled down and we will then put his/her name at the top of the list.
12. What if my child is put on the Acceptable Candidate List but we already have a vacation planned, or for some reason CAN’T BE AVAILABLE WHEN YOU WANT US TO BE? When it is determined that your child’s name will be placed on the Acceptable Candidate List, you will be given the opportunity to inform us of any known calendar conflicts. As time progresses, you can update this information. We will try to work around time periods in which you have other commitments. Of course, the more flexibility and availability you have, the more likely it is that your child can be enrolled.
- If we call you and you tell us that you are not available, we will need to move on without you. Your name will be kept on the Acceptable Candidate List and it is possible that we will call you again.
- It is imperative that once the 18 day data collection begins, you are available for, and prioritize, the commitment.
13. If my CHILD BECOMES ILL prior to or during the study, will he or she be disqualified? If your child develops a fever, flu, mononucleosis or a degree of congestion which will interfere with an accurate dose of the drug or placebo reaching its target, your child’s participation may be deferred or terminated. This will be evaluated by us at the time.
14. What if I want to WITHDRAW MY CHILD’S NAME either from the application process or from the Acceptable Candidate List? You are free to do so. Just contact the Project Manager directly and inform her of you request. You can contact her through our website. Use the comment box located at the bottom of the ketamine study Information Center. You can click here to get to it.
15. What if I want to WITHDRAW MY CHILD FROM THE STUDY once it has started? You are free to withdraw from the study at any time for any reason. You will be informed of this right during a pre-enrollment Informed Consent process. If you should choose to leave the study we would appreciate if it you would share your reason for leaving with the Project Manager so that, if relevant, we can improve the experience for the other families.
16. Once the case has begun, what would cause JBRF TO TERMINATE MY CHILD’S PARTICIPATION? If your child’s degree of compliance prevents the collection of data, or if we cannot safely or effectively administer the drug or placebo, we may need to close the case early. This judgment call will be made at that time.
17. If my child participates in the study but gets assigned to the placebo group, will he or she have the OPPORTUNITY TO TRY KETAMINE AFTER THE STUDY? We are unable to provide this opportunity to you. If we are able to conduct a follow-up study, it is possible that we will try to re-group the children to whom placebo was assigned.
18. What can you tell me that will HELP MY CHILD TO BE MORE COMFORTABLE with participation in the study? All people who will interact with your child are familiar with the particular behavioral and physical challenges posed by the condition. The investigators who created this study have nothing but compassion and respect for children and families like yours. The Project Manager is the mother of an affected child and so understands first-hand the difficulties and heartaches. Finally, research staff members have been hired for their talent and interest in this community and have been trained by the investigators.
We know that there are quite a few aspects of this study that may cause anxiety to your child. While we can’t change what needs to be done for the study, you will have the opportunity to discuss with us what might help to reduce the likelihood of unintentional provocation.
You can reassure your child that the people involved in this study understand how scary and hard things feel to them, that they are trying to help it go away and will be understanding if they are rude, scared, bored, impatient, defiant, etc.
Of course, you should let your child know that being in the study might make them feel much better and may provide information to their local doctor that will help in their future treatment.
But along with this hopeful message it is probably important to add that, even if it doesn’t make them feel better, it is heroic to be part of the team that helps the scientists to figure out the problem; they have been selected to be the voice for all the other boys and girls who deal with the same challenges that they do.
19. DO WE GET PAID for participation in the study? We will pay you $300 compensation for your participation. If you should leave the study prior to its completion, you will be paid on a prorated basis.
20. Is ketamine a SAFE DRUG? Ketamine is considered to be a very safe drug when administered in a manner consistent with good medical practices. It is used as a sedation agent in this country and around the world. When used for sedation, unlike anesthesia, ketamine does not depress the respiratory system so airway support is not needed. Ketamine is a sedation agent of choice in many pediatric emergency rooms and for many dental procedures. In the Ketamine Study Information Center you can find links to two articles which address this. Click here for the Information Center.
21. What are the SIDE EFFECTS of Ketamine? The most well known set of side effects associated with Ketamine are the spacey, dizzy and hallucination-like effects that can follow administration. While these side effects may seem alarming, both to you and your child, it has been well documented that they are not harmful and that these side effects disappear within 60-120 minutes. This is consistent with Dr. Demitri Papolos’ observations of 60+ children and adolescents who he has treated with intranasal ketamine over the past 4 years. (click here for more information about that experience.) Further, his experience informs him that these side effects diminish or disappear completely as the children acclimate to the drug.
Other side effects that your child may experience include nausea, vomiting, burning of the nasal passages and a bad taste in their throat. Over the years of the pilot study, techniques have been developed that minimize the likelihood of spray going down the throat.
Your child may also experience a temporary sensation of chilling.
22. Even if ketamine is regarded as a safe drug, what are the ADVERSE EVENTS associated with it? Please note that we are drawing a distinction between a side effect and an adverse event. The side effects are experiences directly related to the administration of the drug. They are self-resolving and are described in #18. An adverse event is a related complication that results from use of the drug.
Almost all prior medical use of ketamine has been for the purposes of sedation. The current study will not use a dose which will sedate your child. However, for your knowledge, the adverse events associated with a sedative dose have been determined to be clinically insignificant. While there is an extremely small incidence of airway complications, very simple measures such as adjustment of head position or slight ventilation assistance have resolved the problem. The several documented cases of unintentional ketamine overdose, up to 100 times that required, have been followed by prolonged, but complete, recovery. Click here for more details about adverse events.
23. What happens if my child experiences an ADVERSE REACTION TO THE DRUG OR PLACEBO? In the 4+ years that the primary investigator has used the drug in his practice, none of the children have experienced adverse events. There are no adverse events associated with the placebo. However, a Physician’s Assistant, Nurse Practitioner or Advanced Practice Registered Nurse or Registered Nurse will administer the drug/placebo and stay with your child during the 2 hour recovery period. She or he will be able to triage any episode and will have access to basic respiratory equipment as commensurate with established medical practices.
If your child experiences troubling symptoms at any other time during the study, you will have 24 hour access to the primary investigator. As he has familiarity with dose responses, he will be able to identify whether the reaction is one of concern and thereby prompts local medical attention, or if it falls within a benign medical or side-effect range.
Of course, if at any time you have serious concerns that your child is experiencing a serious or life-threatening condition, you should immediately contact local emergency support.
24. How will my child’s PRIVACY BE PROTECTED?
- Only the Primary Investigator and Project Manager will have access to both your child’s name and the data that describes your child’s condition. They have signed confidentiality statements that legally preclude them from discussing the private information gathered in the study.
- Other investigators will not know the names of any of the subjects. They will have anonymized subject ID numbers associated with each data set.
- For obvious reasons, the staff members who come to your home will have complete contact information and be familiar with the responses that describe your child. However, they will have no access to the stored data. Like the Primary Investigator and Project Manager, they too have signed confidentiality agreements.
When participating in a research program hosted by WCDS’s clinical study management, a subject’s personally identifiable information is collected on the StudyEnroller. This system uses only secure HTTPS for all data gathered and stores identity data in an encrypted format. Both of these measures prevent data leakage.
Woodstock Clinical Data Systems (WCDS) is committed to protecting the privacy of its visitors and survey participants and does not access this information outside of the requirements for a particular study program. WCDS will never share or sell information about its visitors or program participants in any way for any purpose. All data remains solely the property of each study program, to be used exclusively by them, and requiring them as well to employ cryptographically secure connections to WCDS servers to retrieve those data. WCDS will always maintain best efforts to stay up to date with system security and technology updates to server software and application software to ensure all information is maintained securely and solely for the purposes of each individual research program.