QUICK POINTS:

  • Properties of ketamine; the reduction core body temperature and the reduction of fear sensitivity, are particularly well suited to treat FOH.
  • As of this writing (March 2014), over 70 people, most of them children, have been treated with intranasal ketamine and have experienced a significant reduction of the symptoms of FOH.
  • Remission of the FOH symptoms can be challenged by other daily and lifelong experiences.
  • Treatment of overlapping psychological issues must be dealt with in order for the benefits of ketamine to be optimized.
  • Responsible monitoring and adjusting of the dose is necessary in order to maximize the benefits of treatment.
  • While improvement is not necessarily easy or continuous, in the long term, the improvement can be profound and life altering.
  • While response to ketamine is remarkably reliable, the appropriate doses for individuals are largely idiosyncratic.
  • Side effects immediately following administration of ketamine typically last between 10-60 minutes and may be quite pronounced. However the severity usually reduces with repeated doses.
  • There have been no adverse health effects on any of the patients who have been treated.

 

DISCUSSION:

Why Ketamine?

Ketamine is a drug used around the world for its ability to provide rapid and safe sedation. It also has been found to be helpful for many other medical purposes. (see Use and Safety of Ketamine: In Plain Terms.) But in addition to these well know clinical uses, several studies have shown that ketamine diminishes fear. Other studies have shown that it lowers lower core body temperature.

The research which defined the FOH syndrome revealed to investigators two important facts about the illness: that fear-of-harm is a primary trait of the condition and that there seems to be a disruption in normal body temperature regulation.  When investigators considered which drug might be useful to treat the condition, it was not a stretch to think that ketamine may be beneficial.

Effects of Ketamine

In 2009, Dr. Demitri Papolos, JBRF Director of Research, recommended to the family of a young, severely affected patient who needed a dental procedure requiring sedation, that they ask their dentist to use ketamine as the sedating agent. The child showed a dramatic and immediate improvement in symptoms. That improvement lasted for almost two weeks. The child has continued treatment with an intranasal formulation of ketamine since then and continues to use it at the time of this writing. This child’s life has thereby taken a very different direction than it was otherwise headed.

What started as a single patient has, as of this writing (March 2014), increased to over 70 patients. While most of them are children or adolescents, their ages range from 5 to 70. All but 2 of those 70+ patients have experienced a marked improvement of symptoms and have been able to manage their symptoms with regular administrations. (2 other patients started a trial of ketamine but did not comply long enough for the trial to be considered relevant.)

It seems that ketamine significantly reduces many of the primary symptoms of FOH: As ketamine corrects the body temperature problem, not only does the pattern and quality of sleep improve, but behavior dramatically shifts into a less reactive state. Patients experience a sense of calm and control which, for many of them, has been previously unknown. From this calmer, more measured state, they are able to interact more effectively with situations and people. Some of these breakthroughs are immediately observable. With proper dose titration and management, the steady and sustained stability allows the patient to move out in his or her world and accrue life experiences that were previously out of reach.

Challenges to Treatment

However, ketamine is not a cure…it is a treatment. And while the long term result may be profound and even life-saving, the journey is not simple or total or guaranteed. Understandably, different children achieve varying levels of symptom remission; differences derive from where they started out, what their other difficulties may be, and what they encounter along the way.

In almost every case, an immediate and notable improvement is evidenced within the first several administrations. But life is complicated…especially life with FOH.  While the effect of ketamine may better position the brain to respond in a healthy manner, strong influences will continue to challenge that capability. Particularly common challenges include:

  • The effect of well engrained psychological associations and patterns: It may well be the case that ketamine temporarily shifts the child’s brain and body to function more effectively. However negative psychological associations which have built up over a life time are difficult to undo. Anticipatory anxiety, low self-esteem, damaged or detrimental relationships, unhealthy habits all need to be addressed simultaneously. This underscores the advantage of early intervention.
  • New and/or significantly stressful experiences: Experiences such as transferring to a new school or experiencing a traumatic incident can derail a prior level of stability and require an adjustment in dose or the addition of other adjunct medications.
  • Temperature changes: Given the primary importance of body temperature to the expression of the condition, changes in environmental temperature are a constant challenge. Temperature variations occur between seasons, between days, and even between different climate-controlled environments. Severe cases of FOH are extremely sensitive to even the smallest of changes. Physical exertion and fever also create spikes in temperature. All of these things may lead to overheating and a breakthrough of symptoms. (see FOH and Thermoregulation)
  • Changes in other medications: As the child becomes significantly more stable on ketamine, other meds can be reduced and/or eliminated. However it can be a delicate process not to upset the apple cart while doing so. Some drugs require a very long tapering down time during which there may be a continuous loss and regaining of the previously achieved stability.
  • Effects of alcohol and other recreational drugs: It is interesting to know that alcohol lowers body temperature. But the rebound causes overheating and a greater disturbance to the system. Despite its increasing acceptance, investigators believe that marijuana is also problematic for those with FOH. Studies indicate a negative effect on short term memory which would, in turn, lead to increased difficulty and anxiety putting pressure on stability.
  • Other illnesses: The effect of fever and medications necessary to manage medical conditions may interfere with the effectiveness of the ketamine.
  • Growth and development: While there is no reliable correlation between dose levels and the weight or age across patients, these things do matter within the experience of any single patient. As the brain and body mature, adjustments may need to be made up or down. Without constant monitoring and responding to changes, a therapeutic balance may be lost and a downward slope begins.

So when we say that almost all of the 70+ children and adults have responded to treatment, we mean that for each one of them, there has been an observable effect of ketamine to dramatically reduce the symptoms primary to FOH. However, how that response translates over the long term is a product of multiple factors.

With diligent management, despite the dips, gains usually continue. This is an enormous improvement over the sinking direction that this typical of this condition. Children who refused to go to middle school are going to college. Children who might otherwise have been placed in a residential facility are able to stay home and have relationships with their siblings.  They are going to sleep without their mothers staying in their rooms. They are enjoying activities and self-esteem that they previously couldn’t develop.

Because ketamine targets what investigators believe to be the source of the illness, the effect of the treatment is much more reliable and substantial than previous treatment options which are often just hit-or-miss Band-Aids for one set of symptoms or another.

What is the Treatment Regimen?

A therapeutic dose is idiosyncratic meaning that the quantity of drug depends upon the individual. For some children the dose that provides long term stability is 4 or 5 times the dose required for others. The difference is neither age nor weight dependent. While children who are highly affected by FOH typically need a higher dose, that is not a hard and fast rule.

Further, the interval between doses, determined by a return of symptoms, also varies. The range of that interval can be as short as 2 days, more typically 3-4 days and even as long as 7 days. Some of the patients who have been on the treatment the longest; in excess of 4 years, are beginning to be able to significantly lengthen the time between administrations. It is too early to know if the sustained correction of problematic brain networks is actually allowing the brain to slowly rewire itself in a way that eliminates or reduces the symptoms permanently. But this is an interesting and encouraging observation.

Clearly, given all of these variations, directions for how to administer intranasal ketamine are not yet able to be printed on the side of a box. At this point, the 5+ years of experience that Dr. Papolos has accumulated provide him with insight as to how to progress with each case. It is the strong desire and intention of both Dr. Papolos and the JBRF to transfer this knowledge to the professional community as quickly and effectively as possible. Completion of the Ketamine Clinical Study will be an important step in this direction.

Side Effects of Treatment

None of the patients from Dr. Papolos’ practice have experienced any clinically significant side effects. Typical side effects immediately following administration include: dizziness, loss of balance, confusion, spaciness, elation, activation, perceptual distortion (sound, color, distance, size), dissociation (feelings of being outside of yourself or in a dream, time slowing down…), heavy feeling limbs or head, burning in the throat or nose, numbness in lips, sensation of cooling. Less common side effects include headache, nausea, and hallucinations. Infrequently there has been mild heart palpitation and mild respiratory distress.

No single person experiences all of these effects and some people hardly experience any. Typically a person is prone to one or two of them and these will be the ones that continue to characterize that person’s side effect experience. Dizziness is perhaps the most frequent. Regardless of the side effect(s) experienced, tolerance usually develops quickly. Tolerance means that within a few administrations of a dosing level, the side effects diminish in severity and duration; they may even disappear entirely. (That said, a few patients have not developed significant tolerance.) When the effects are present, they usually last 10 minutes to an hour. Rarely does any significant amount of effect go beyond an hour however some children become sleepy and feel like they need to take a nap.

In addition to the immediate side effects  described above, ketamine has been linked to a serious adverse effect related to bladder function. However, this problem is associated with a much higher and abusive use of the drug. No patients in the practice have experienced any ketamine-related bladder function conditions.

 

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