A Within-Subject Randomized Controlled Trial on the Effects of Phenytoin on Social Cognition and Behaviour in Males aged 16 Years and Older with Autism Spectrum Disorders
- Conditions
- Autism Spectrum DisorderMental Health - Autistic spectrum disorders
- Registration Number
- ACTRN12614000747628
- Lead Sponsor
- niversity of Sydney
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- 20
Meet DSM-IV-TR criteria for Autistic Disorder, Pervasive Developmental Disorder-Not Otherwise Specified or Asperger’s Disorder
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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improved social cognition as assessed by the Eye-Gaze Movie Scene Task - duration (total milliseconds spent fixating on the face region) and fixation count (number of times a participant fixated toward a face region).[45 minutes after each single dose administration];Improved accuracy and speed of identification of the correct emotion from faces as assessed by the Reading the Mind in the Eyes Test (RMET) and the Speeded Face Expression Recognition Task.[45 minutes after each single dose administration];Increased Heart Rate Variability assessed by the Polar RS800CX heart rate monitoring system[45 minutes after each single dose administration]
- Secondary Outcome Measures
Name Time Method Improved capacity to correctly respond to social cues as assessed by the Social Ball-tossing Game. [45 minutes after each single dose administration]