Can you tell the difference?
Is There a Role for Clozapine in the Treatment of Children and Adolescents?
Findling, Robert L.; Frazier, Jean A.; Gerbino-Rosen, Ginny; Kranzler, Harvey N.; Kumra, Sanjiv; Kratochvil, Christopher J.
Journal of the American Academy of Child & Adolescent Psychiatry, v46 n3 p423 Mar 2007
Journal of the American Academy of Child & Adolescent Psychiatry, v46 n3 p423 Mar 2007
"This article presents responses to the question of whether clozapine is ever appropriate to use in the pediatric population. Among others, Jean A. Frazier also agreed that clozapine is appropriate for use in the pediatric population. Clozapine has truly revolutionized the treatment of refractory patients with schizophrenia at any age. This agent was approved by the U.S. Food and Drug Administration (FDA) in 1989 for use in individuals ages 18 years or older with treatment refractory schizophrenia. Subsequent to clozapine, the FDA has approved a number of atypical antipsychotics for the treatment of psychotic disorders, but none to date are approved for use in children and adolescents. Despite the superior efficacy of clozapine, its use has been limited because of its complex side effect profile, consisting of hypersalivation, weight gain, metabolic abnormalities, cardiovascular side effects, sedation, seizures, and agranulocytosis. Children may be more prone to developing these side effects than adults because of developmental differences in the metabolism of this agent."
via Highbeam Business:
Is there a role for clozapine in the treatment of children and adolescents?
Article from: Journal of the American Academy of Child and Adolescent Psychiatry | March 1, 2007 | Findling, Robert L.; Frazier, Jean A.; Gerbino-Rosen, Ginny; Kranzler, Harvey N.; Kumra, Sanjiv; Kratochvil, Christopher J. | Copyright Journal of the American Academy of Child and Adolescent Psychiatry
IS THE USE OF CLOZAPINE EVER APPROPRIATE IN THE PEDIATRIC POPULATION? IF APPROPRIATE, WHEN AND HOW WOULD YOU MANAGE ITS USE IN CHILDREN AND ADOLESCENTS?
Robert L. Findling, M.D.
The question of whether clozapine is ever appropriate to use in the pediatric population is an important one. At present, according to the U.S. Food and Drug Administration (FDA), clozapine is indicated for patients with treatment-resistant schizophrenia and may be prescribed for patients with psychotic illnesses to lower the risk of suicidal behavior. The reason that clozapine is reserved for use with patients who are not responsive to other interventions is because clozapine therapy can lead to agranulocytosis, seizures, and myocarditis. Clozapine is currently not approved for use in pediatric patients.
Despite these facts, treatment with clozapine is considered for some children and adolescents who are suffering from severe, disabling psychopathology who do not respond to or cannot tolerate first- or even second-line medication interventions for which clozapine therapy may be considered. Although the use of clozapine has been described in several pediatric patient populations, the best evidence supporting its use in children or adolescents are in youths with treatment-resistant psychotic illnesses or in young people with treatment-resistant bipolar illness (Findling et al., 2005). It should be emphasized that the use of clozapine has not been rigorously studied in aggressive youths with primary diagnoses of disruptive behavior disorders. Because of this lack of evidence and the side effect profile of clozapine, use in aggressive patients with primary diagnoses of disruptive behavior disorders is not recommended. Although some of the data relating to clozapine's use in the young may not be methodologically stringent or extensive, what information is available does suggest that clozapine may be helpful when reserved for use in some seriously ill patients with treatment-resistant schizophrenia or bipolar illness.
In short, the answer to the question posed is "yes." Clozapine therapy may be appropriate for some pediatric patients with psychotic disorders or bipolar illnesses who do not respond to other forms of pharmacotherapy.
Now that the diagnoses of the patients for whom clozapine therapy may be beneficial have been identified, the more complicated and difficult issue is the question of at what point in the course of treatment does one consider clozapine therapy for patients with psychotic disorders? When only typical antipsychotics and clozapine were available, the time at which one may have considered clozapine therapy for patients may have been clearer. Patients who failed treatment with one typical antipsychotic often failed treatment with another. Thus, a patient who failed to respond to two typical antipsychotic medication trials may have been considered an acceptable candidate for clozapine therapy. However, in this era of multiple pharmacologically distinct first-line atypical antipsychotics (as well as continued availability of typical antipsychotics), it is not clear when one may consider the use of clozapine for young patients with treatment-resistant schizophrenia. In the absence of definitive data, clinical judgment and patient/family choice become the key factors. It may be suggested that one could consider only clozapine for a patient who had clearly failed to have a substantive reduction in psychopathology after treatment with at least three different antipsychotics (two atypicals and one typical). As part of the general evaluation of patients who are failing to respond to therapy, it is strongly recommended that one considers the many reasons that patients may not be responding to treatment. A careful diagnostic reassessment is often prudent. In addition, environmental factors and possible nonadherence to prescribed medications should also be considered. At that point, I would think about discussing the option of clozapine therapy with the patient's guardians and, as appropriate, with the patient.
Expert consensus guidelines have recently been published for pediatric bipolar illness … here
All due respect to the "experts," without clinical trial data, or data from real world clinical practice, their consensus "opinion" is not an ethical treatment recommendation. Without definitive evidence of Clozapine being effective, not simply "efficacious;" and definitive evidence that the benefits out-weigh the tremendous risks for disabling adverse effects, how can a group of "medical scientists" ethically recommend a treatment based only upon agreement? The Guideline is based on a consensus of agreement and was published in a so-called "peer-reviewed professional journal" in 2007, it was developed from answers on a survey! Subjective observation,and/or subjective opinion is considered to be the weakest most unreliable 'evidence' in scientific research, for this reason, it is used to support empirical clinical data; it is not a substitute! Expert Consensus Guidelines are a commercial product, they are not a derived from scientific research or clinical trial data.
This "expert" guideline was issued one year after my son had become an adult. By his 18th Birthday, he had been taking Clozapine for 5 years...without consent and in spite of my protests---The psychiatric "doctors" refused to discuss lowering the dosages, or the profound deleterious adverse effects my son was experiencing. One actually told me it doesn't matter what my son's diagnosis is/was. Both of them said I had no say; like Jon McClellan had. Supposedly, since my brain-damaged son was over the age of 13, my informed consent wasn't needed...
via Highbeam Business:
Is there a role for clozapine in the treatment of children and adolescents?
Article from: Journal of the American Academy of Child and Adolescent Psychiatry | March 1, 2007 | Findling, Robert L.; Frazier, Jean A.; Gerbino-Rosen, Ginny; Kranzler, Harvey N.; Kumra, Sanjiv; Kratochvil, Christopher J. | Copyright Journal of the American Academy of Child and Adolescent Psychiatry
IS THE USE OF CLOZAPINE EVER APPROPRIATE IN THE PEDIATRIC POPULATION? IF APPROPRIATE, WHEN AND HOW WOULD YOU MANAGE ITS USE IN CHILDREN AND ADOLESCENTS?
Robert L. Findling, M.D.
The question of whether clozapine is ever appropriate to use in the pediatric population is an important one. At present, according to the U.S. Food and Drug Administration (FDA), clozapine is indicated for patients with treatment-resistant schizophrenia and may be prescribed for patients with psychotic illnesses to lower the risk of suicidal behavior. The reason that clozapine is reserved for use with patients who are not responsive to other interventions is because clozapine therapy can lead to agranulocytosis, seizures, and myocarditis. Clozapine is currently not approved for use in pediatric patients.
Despite these facts, treatment with clozapine is considered for some children and adolescents who are suffering from severe, disabling psychopathology who do not respond to or cannot tolerate first- or even second-line medication interventions for which clozapine therapy may be considered. Although the use of clozapine has been described in several pediatric patient populations, the best evidence supporting its use in children or adolescents are in youths with treatment-resistant psychotic illnesses or in young people with treatment-resistant bipolar illness (Findling et al., 2005). It should be emphasized that the use of clozapine has not been rigorously studied in aggressive youths with primary diagnoses of disruptive behavior disorders. Because of this lack of evidence and the side effect profile of clozapine, use in aggressive patients with primary diagnoses of disruptive behavior disorders is not recommended. Although some of the data relating to clozapine's use in the young may not be methodologically stringent or extensive, what information is available does suggest that clozapine may be helpful when reserved for use in some seriously ill patients with treatment-resistant schizophrenia or bipolar illness.
In short, the answer to the question posed is "yes." Clozapine therapy may be appropriate for some pediatric patients with psychotic disorders or bipolar illnesses who do not respond to other forms of pharmacotherapy.
Now that the diagnoses of the patients for whom clozapine therapy may be beneficial have been identified, the more complicated and difficult issue is the question of at what point in the course of treatment does one consider clozapine therapy for patients with psychotic disorders? When only typical antipsychotics and clozapine were available, the time at which one may have considered clozapine therapy for patients may have been clearer. Patients who failed treatment with one typical antipsychotic often failed treatment with another. Thus, a patient who failed to respond to two typical antipsychotic medication trials may have been considered an acceptable candidate for clozapine therapy. However, in this era of multiple pharmacologically distinct first-line atypical antipsychotics (as well as continued availability of typical antipsychotics), it is not clear when one may consider the use of clozapine for young patients with treatment-resistant schizophrenia. In the absence of definitive data, clinical judgment and patient/family choice become the key factors. It may be suggested that one could consider only clozapine for a patient who had clearly failed to have a substantive reduction in psychopathology after treatment with at least three different antipsychotics (two atypicals and one typical). As part of the general evaluation of patients who are failing to respond to therapy, it is strongly recommended that one considers the many reasons that patients may not be responding to treatment. A careful diagnostic reassessment is often prudent. In addition, environmental factors and possible nonadherence to prescribed medications should also be considered. At that point, I would think about discussing the option of clozapine therapy with the patient's guardians and, as appropriate, with the patient.
Expert consensus guidelines have recently been published for pediatric bipolar illness … here
All due respect to the "experts," without clinical trial data, or data from real world clinical practice, their consensus "opinion" is not an ethical treatment recommendation. Without definitive evidence of Clozapine being effective, not simply "efficacious;" and definitive evidence that the benefits out-weigh the tremendous risks for disabling adverse effects, how can a group of "medical scientists" ethically recommend a treatment based only upon agreement? The Guideline is based on a consensus of agreement and was published in a so-called "peer-reviewed professional journal" in 2007, it was developed from answers on a survey! Subjective observation,and/or subjective opinion is considered to be the weakest most unreliable 'evidence' in scientific research, for this reason, it is used to support empirical clinical data; it is not a substitute! Expert Consensus Guidelines are a commercial product, they are not a derived from scientific research or clinical trial data.
This "expert" guideline was issued one year after my son had become an adult. By his 18th Birthday, he had been taking Clozapine for 5 years...without consent and in spite of my protests---The psychiatric "doctors" refused to discuss lowering the dosages, or the profound deleterious adverse effects my son was experiencing. One actually told me it doesn't matter what my son's diagnosis is/was. Both of them said I had no say; like Jon McClellan had. Supposedly, since my brain-damaged son was over the age of 13, my informed consent wasn't needed...
What do you want to bet the clinical trial data these "experts" did have, did not support their "expert" opinions; which is why they took surveys to to write these marketing manuals, er. I mean guidelines.
If these "doctors" had data to support their opinion, they wouldn't have had rely on the weakest data in scientific endeavors that other fields of scientific research, use to support empirical data---not as a substitute or a replacement!
I must admit I am extremely biased. I bear witness to how my precious child was treated like a guinea pig by a psychiatric research 'expert' who repeatedly traumatized, and ultimately disabled him. My son is struggling to recover from what he describes as "torture," being "traumatized over and over and over" by the people who were "supposed to be helping me." Mental health and social service 'professionals' continue to treat my son as if his diagnosis lowered his worth as a human being, as if his psychiatric diagnosis somehow means my son is unworthy of respect. Traumatic treatment experiences are denied altogether, it's demoralizing to be continually invalidated by mental health and social service professionals who are supposed to be helping, but instead repeatedly traumatize, then invalidate my son entirely---by denying therapeutic treatment for his profound iatrogenic injuries and impairments caused by the biological "treatment;" and the emotional injuries caused by mental health 'standards of care', i.e. manipulative, coercive mistreatment.
I must admit I am extremely biased. I bear witness to how my precious child was treated like a guinea pig by a psychiatric research 'expert' who repeatedly traumatized, and ultimately disabled him. My son is struggling to recover from what he describes as "torture," being "traumatized over and over and over" by the people who were "supposed to be helping me." Mental health and social service 'professionals' continue to treat my son as if his diagnosis lowered his worth as a human being, as if his psychiatric diagnosis somehow means my son is unworthy of respect. Traumatic treatment experiences are denied altogether, it's demoralizing to be continually invalidated by mental health and social service professionals who are supposed to be helping, but instead repeatedly traumatize, then invalidate my son entirely---by denying therapeutic treatment for his profound iatrogenic injuries and impairments caused by the biological "treatment;" and the emotional injuries caused by mental health 'standards of care', i.e. manipulative, coercive mistreatment.
