Pediatric Traumatic Brain Injury and Autism: Elucidating Shared Mechanisms
Selected compounds under consideration for the treatment of ASD.
Putative mechanism of action
Randomized, double-blind, placebo-controlled crossover study in patients with Fragile X Syndrome (FXS), the most common inherited cause of intellectual disability and autism;
(i) No significant effects overall on Aberrant Behavior Checklist–Community Edition (ABC-C) score or repetitive behaviors (ii) Patients with full FMR1 promoter methylation had improved ABC-C score, while those with partial promoter methylation had no response (iii) Most common adverse events were fatigue and headache
Open-label retrospective study in youths with ASD;
(i) Eleven responders [rating of “much improved” or “very much improved” on the Clinical Global Impressions-Improvement scale (CGI-I)] (ii) Improvement was primarily seen clinically in social withdrawal and inattention (iii) Adverse effects occurred in seven subjects patients and led to drug discontinuation in 4 of 18 (22%) patients.
Randomized, double-blind, placebo-controlled, 10-week study in children with autism;
(i) Adjunct therapy to risperidone produced greater reduction in ABC-C subscale scores for irritability, stereotypic behavior, and hyperactivity (ii) Most common adverse events were sedation and dizziness
(i) Significant improvement on memory test (Children’s Memory Scale Dot Learning Subtest) (ii) No significant effects on expressive or receptive language or nonverbal IQ (iii) Significant improvements on a number of ABC subscales, including hyperactivity, lethargy, and irritability.
Randomized, double-blind, placebo-controlled crossover study in patients with FXS;
(i) No significant effects on ABC-Irritability (ABC-I) subscale or on irritability (ii) Favorable effects on social function, with improvements on the ABC-Social Avoidance scale and Vineland II–Socialization raw score (iii) Most common adverse events were sedation and headache
Open-label, 8-week trial in children and adolescents with ASD and a score ≥ 17 on the ABC-I subscale;
(i) Improvements on ABC-I and the Lethargy/Social Withdrawal subscales, the Social Responsiveness Scale, the CY-BOCS-PDD, and clinical global impression scales (ii) Most common adverse events were transient agitation and irritability, which were often felt to represent spontaneous variation in underlying symptoms
(i) Associated with improvement in social behavior and a reduction in inattention/hyperactivity (ii) Pre- and posttreatment blood biomarker analyses looking at brain-derived neurotrophic factor (BDNF) levels found a significant increase in BDNF with treatment
Randomized, double-blind, placebo-controlled cross over trial in adults with ADS;
(i) Improved social interactions in a simulated ball game where participants interacted with fictitious partners (ii) Increased subjects’ gazing time on the socially informative region of the face, namely the eyes, during free viewing of pictures of faces
Randomized, double-blind, placebo-controlled, parallel trial in adults with ASD;
(i) No significant effects on measures of social function/cognition (the Diagnostic Analysis of Nonverbal Accuracy) and repetitive measures (Repetitive Behavior Scale Revised) (ii) Improvements in measures of social cognition (RMET), and quality of life (World Health Organization Quality of Life Questionnaire-Emotion)
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