None listed
Conditions
Brief summary
The aim of the trial is to conduct the first study of the impact of Phenytoin administration (4mg) on key mechanisms involved in social communication in youth aged 16 years and older with Autism Spectrum Disorders. We hypothesize that Phenytoin will, in comparison to an identical and matched placebo: increase gaze duration and fixations to key face regions, improve accuracy and the speed of identification of facial emotion recognition, increase heart rate variability, and improve accuracy of response to social cues.
Interventions
Participants receive both treatments in a random order. Participants are randomised to receive either a single dose oral administration of 4mg syrup of Phenytoin or Placebo, followed by a two week wash-out period and then a single dose administration of 4mg syrup of Phenytoin or Placebo.
Sponsors
University of Sydney
Study design
Allocation
Randomised controlled trial
Intervention model
Crossover
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
Male
Age
16 Years to 50 Years
Healthy volunteers
No
Inclusion criteria
Meet DSM-IV-TR criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger’s Disorder
Exclusion criteria
Severe depression, with suicidal thoughts and/or actions; Severe cardiovascular problems; Kidney or Liver problems; Allergies to barbiturates or any other anticonvulsant medicine; Allergies to foods, preservatives or dyes that may be contained in the syrup; Psychosis; Smoke more than 15 cigarettes a day; Phenytoin hypersensitivity; Pregnancy or lactation; High blood sugar levels Concomitant medications that exclude participants: lcuronium, antineoplastic agents, amiodarone, amphotericin B, azapropazone, azoles, capecitabine [or its metabolite fluorouracil (5FU)], carbamazepine, ciprofloxacin, chloramphenicol, chlordiazepoxide, chlorpropamide, cimetidine, clopidrogel, clozapine, corticosteroids, coumarin anticoagulants, cyclosporine, diazepam, diazoxide, dicumarol, digitoxin, diltiazem, disulfiram, doxycycline, erythromycin, felbamate, fluconazole, fluorouracil, fluoxetine, folic acid, frusemide, fluvoxamine, glibenclamide, H2-antagonists, halothane, isoniazid, itraconazole, ketoconazole, lamotrigine, methadone, methylphenidate, miconazole, nelfinavir, nicardipine, nimodipine, nifedipine, oestrogens, omeprazole, pancuronium, paroxetine, phenobarbitone, phenothiazines, phenylbutazone, praziquantel, quinidine, reserpine, rifampicin, salicylates, sertraline, sodium valproate, succinimides (ethosuximide, methsuximide, phensuximide), sucralfate, sulfonamides, teniposide, tetracycline, ticlopidine, theophylline, tolbutamide, trazodone, valproic acid, verapamil, vecuronium, vigabatrin, viloxazine; Hypericum perforatum (St John's wort); Antacid preparations containing calcium; Vitamin D
Outcome results
None listed