Table 1. Demographic and Phenotypic Baseline Data by Study Group.
Riluzole | Placebo | P | |||
---|---|---|---|---|---|
N | 30 | 30 | |||
Diagnostic group (OCD:OCD+ASD) | 21 : 9 | 22 : 8 | 0.77 | ||
Male:female | 22 : 8 | 22 : 8 | 1.00 | ||
Mean | SD | Mean | SD | ||
Age in years | 14.78 | 2.10 | 14.17 | 2.58 | 0.32 |
Cognitive scorea | 97.93 | 18.68 | 92.93 | 23.99 | 0.39 |
Total CY-BOCS | 27.24 | 3.78 | 29.13 | 3.59 | 0.053 |
CGAS | 41.59 | 7.57 | 40.17 | 7.68 | 0.48 |
Comorbid psychiatric disorders | 2.33 | 1.37 | 2.03 | 1.52 | 0.43 |
Concomitant medications | 2.07 | 1.08 | 1.87 | 1.11 | 0.48 |
n | % | n | % | ||
SRI (with or without other med.)b | 23 | 77 | 20 | 67 | |
SRI only | 4 | 13 | 6 | 20 | |
Antipsychotic | 17 | 57 | 15 | 50 | |
Stimulant | 9 | 30 | 4 | 13 | |
Alpha agonist | 1 | 3 | 5 | 17 | |
Anti-seizure | 6 | 20 | 7 | 23 | |
Other | 3 | 10 | 4 | 13 | |
No medication | 2 | 7 | 3 | 10 | |
Tics | 14 | 47 | 14 | 47 | 1.00 |
Abbreviations: CGAS, Children's Global Assessment Scale; CY-BOCS, Children's Yale-Brown Obsessive–Compulsive Scale; SRI, serotonin reuptake inhibitor. Comorbid conditions do not include ASD. p value reflects test of difference between treatment groups.
Cognitive data were available for 55 participants, riluzole (n=28), placebo (n=27). The subjects with OCD+ASD had an average full-scale cognitive score of 85.50±22.71.
Medication categories are not mutually exclusive; most children received an SSRI plus another medication. Some children received a non-SSRI medication only: antipsychotic, RIL=2 (7%), PLA=7 (23%); stimulant, RIL=2 (7%), PLA=1 (3%); alpha-agonist, RIL=1 (3%), PLA=0; anti-seizure, RIL=1 (3%), PLA=3 (10%); and other, RIL=1 (3%), PLA=4 (13%).