Steroid Therapy for Autistic Children

• Register: REBEC
• Last refreshed on: 29 April 2013
• Main ID: RBR-7nq8m7
• Date of registration: 12/04/2011
• Primary sponsor: HUAP - Brazil
• Public title: Steroid Therapy for Autistic Children
• Scientific title: Double-blind, Randomized, Placebo-Controlled Clinical Trial of Corticosteroids for the Autistic Spectrum Disorder - CAST: Corticosteroids for Autism - A Scientific Trial
• Date of first enrolment: 01/05/2010
• Target sample size: 40
• Recruitment status: recruiting
• URL: http://www.ensaiosclinicos.gov.br/rg/RBR-7nq8m7/
• Study design: Placebo-controlled, randomized, double-blind study.

Countries of recruitment

Brazil

Contacts

• Name: Adriana Brito
• Affiliation: HUAP

• Name: Marcio Vasconcelos
• Affiliation: HUAP

Key inclusion & exclusion 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: 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.

Age minimum: 3Y
Age maximum: 7Y
Gender: M

Health Condition(s) or Problem(s) studied

F00-F99

The classical clinical picture of autistic spectrum disorder.
F03.550.325.125

Intervention(s)

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 mg/kg on alternate days. During the following eight weeks, the study medication will continue to be given on alternate days and will be tapered as follows: 10% reduction of the initial dosage every week between the seventeenth and the twentieth weeks, then a 15% reduction per week on the twenty first through the twenty fourth weeks. Control Group: 20 subjects will receive a placebo dosage throughout 24 weeks, according to the same dosage as the active substance.

Primary Outcome(s)

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 Outcome(s)

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.

Secondary ID(s)

167/07

CAAE 0136.258.000-07

Source(s) of Monetary Support

CNPq - Brazil

HUAP - Brazil

Secondary Sponsor(s)

HUAP - Brazil