The classical clinical picture of autistic spectrum disorder.
Conditions
Interventions
Intervention Group: 20 subjects will receive oral prednisolone, in a dosage of 1 mg/kg/day, daily during eight weeks. From the ninth through the sixteenth weeks, patients will received a dosage of 1 m
Drug
Sponsors
HUAP
Eligibility
Sex/Gender
Male
Age
3 Years to 7 Years
Inclusion criteria
Inclusion criteria: Male gender. Age range, 3-7 years. Autistic spectrum disorder diagnosed according to the criteria at the Diagnostic and Statistical Manual of Mental Disorders-Fourth Edition-Text Revision (DSM-IV-TR). The subject's parents should read and sign the informed consent form, authorizing the researchers to recruit their child and to prescribe prednisolone.
Exclusion criteria
Exclusion criteria: Diagnosis of epilepsy. Diagnosis of a neurodegenerative disease. Diagnosis of cerebral malformations. Past history of meningitis or encephalitis. Diagnosis of a mass lesion in the central nervous system. Diagnosis of any other neurologic disorder. Gestational history suggestive of fetal or perinatal distress. Patient dos not fully meet the diagnostic criteria of autism. Patient's parents or caretakers did not sign the informed consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The study primary endpoint is the subject's language function. During the course of the clinical trial, each subject will undergo four standardized assessments of his/her speech and language. Every assessment is performed by a speech pathologist and consists of the application of three formal tools, i.e.: ABFW (Language Assessment Test, a Brazilian test validated for autistic children). ADL (Language Development Assessment, another Brazilian test) and PEABODY (Picture Vocabulary Test, Third Edition). Each one these tools produces a score, and improvement criterion will be the score increase in the active substance group compared with the control group. Average increase in each score will be compared between the two groups using the unpaired Student's t test, and statistical significance is defined as lower than or equal to 0.05. | — |
Secondary
| Measure | Time frame |
|---|---|
| The study secondary endpoint is the subject score at CARS (Childhood Autism Rating Scale). Each subject receives a score just before the trial beginning and, immediately after the trial period, the scale score is reassessed. Degree of improvement in both groups will be measured and compared according to the score increase. | — |
Countries
Brazil
Contacts
Public ContactAdriana;Marcio Brito;Vasconcelos
HUAP;HUAP
Outcome results
None listed