- Is your son 2D6 deficient?
- Does your son have predominant Axis I disorder other than MDD (e.g. dysthymic disorder, eating disorders, Specific phobia, PTSD, OCD, Panic disorder, etc?
- Has your son ever had any history of a psychotic episode or psychotic disorder (including schizophrenia ), or complication of these diseases?
- Does your son have a history of a bipolar disorder, or complication of these diseases?
- Does he have Attention-Deficit, or Hyperactivity Disorder?
- Does he have Mental Retardation or Pervasive Development Disorder?
- Has your son ever taken any drugs that have led to Substance Abuse or Dependence?
- Has he ever been treated with Paxil before?
- Has he, in the past 12 weeks been treated with electroconvulsive therapy?
- Does he have a past history of serotonin syndrome and neuroleptic malignant syndrome?
- Does he have a CDRS-R score of "suicidal ideation" of 3 or greater. Or did his C-SSRS assessment suggest that they he has been a significant risk for harming himself or has actually harmed himself?
- Does he have a past history of suicide attempt, self harm(excluding "no suicidal intent " ), or an intentional overdose (excluding obviously unintentional overdose)?
- Does he have glaucoma?
- Does he have convulsive disorders such as epilepsy or past history of these diseases?
- Is he using drugs (e.g. NSAIDs) that would increase the risk of hemorrhage, or has he had bleeding tendency or hemorrhagic diathesis?
- Does he have severe renal and hepatic disorder?
- Does he have a serious organic disorder in the brain?
- Does he have chronic hepatitis type B and/or C which is positive of hepatitis B surface antigen (HBsAg) and/or hepatitis C antibody?
- Does he have a current history of carcinoma or malignant tumor, or complication of these diseases?
- Does he have clinical significant co morbid impulsivity symptoms.(e.g. Personality Disorder, Conduct Disorder)?
- Finally, one question the doctor WILL NOT be able to ask this mother would be
- Has he, in the opinion of a 'specialist', been judged as not appropriate for Paxil?
A huge list of questions for any doctor but ones that should be asked if Paxil is granted a license for use in children in Japan. If it's good enough for GlaxoSmithKline to exclude subjects from the trial because they don't meet the criteria then it's fair to say that doctors should be concerned and ask the patient or the patient's parents the above questions.
Two questions I have put to GlaxoSmithKline in an email are thus:
1- What exactly does the exclusion criterion "Patients in the opinion of the chief investigator (subinvestigator) judged as not eligible for the study" mean? What other criteria might this include not already listed. Could it possibly mean that children & adolescents will be pre-screened, by genetic testing to be sure that they are not deficient in the CYP450-2D6 enzyme that Paxil desperately needs to be safely cleared from a persons system. Will these kids not be included in the study?
2- Does the long list of exclusion criteria really represent the real world of kids that will be prescribed this drug in Japan, if it is approved. Will doctors use this same list of criteria when deciding to prescribe Paxil to their young Japanese patients?
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You have to ask yourselves if GlaxoSmithKline used the same criteria in other trials for Paxil other than trials for children. Whatever or whomever they excluded in all of the Paxil trials should be made abundantly clear to all.
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