Risperidone versus haloperidol in children and adolescents with AD : a randomized, controlled, double-blind trial.
OBJECTIVE
The aim of the study was to compare safety, efficacy and tolerability of risperidone with haloperidol in the treatment of Autistic Disorder (AD).


METHODS
This study was designed as a double-blind, prospective, for a 12-week period. A total of 30 subjects, between the ages of 8 and 18 with AD based on DSM IV criteria, were included in the study. Behavioral Rating Scales were performed by the investigators and the parents. Safety assessment included vital signs, electrocardiogram, electroencephalogram, adverse events, laboratory tests, extrapyramidal symptoms and the side effects. Both treatments were applied in a once daily dosage regimen of 0.01-0.08 mg/kg/day.


RESULTS
The reduction from baseline in Ritvo-Freeman Real Life Rating Scale (RF-RLRS), sensory motor (subscale I) and language (subscale V) scores were significant in risperidone group (P < 0.05). Compared to haloperidol, risperidone led to a significantly greater reduction in the Aberrant Behavior Checklist (ABC) and Turgay DSM-IV Pervasive Developmental Disorder (PDD) scale scores (P < 0.05 and P < 0.01). There was a greater increase of prolactin in the risperidone group, while alanine amino transferase (ALT) had further increased in the haloperidol group. Sensory motor behaviors (subscale I) and language at the end of the 12th week, RF-RLRS sensory motor and language subscale scores decreased in the risperidone group further than the other group (P < 0.05).


CONCLUSIONS
Risperidone was found to be more effective than haloperidol in the treatment of behavioral symptoms, impulsivity, language skills, and impaired social relations in children with AD. These results demonstrated that both drugs were safe and well tolerated in the treatment of AD.
Miral
Suha
S
Department of Child and Adolescent Psychiatry, Dokuz Eylul University Faculty of Medicine, 35340 Narlidere, Izmir, Turkey. suha.miral@deu.edu.tr
Gencer
Ozlem
O
Inal-Emiroglu
F Neslihan
FN
Baykara
Burak
B
Baykara
Aysen
A
Dirik
Eray
E
D000293:Adolescent; D000410:Alanine Transaminase / Q000097:blood; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use*; D001321:Autistic Disorder / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D002648:Child; D002653:Child Behavior Disorders / Q000175:diagnosis / Q000188:drug therapy; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D004409:Dyskinesia, Drug-Induced / Q000209:etiology; D005260:Female; D006801:Humans; D008297:Male; D017063:Outcome Assessment, Health Care; D010552:Personality Assessment; D011388:Prolactin / Q000097:blood; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*
D014150:Antipsychotic Agents; D011388:Prolactin; D000410:Alanine Transaminase; D018967:Risperidone