Table 2.

Published Open-Label Studies of Stimulant Treatment of Attention-Deficit/Hyperactivity Disorder in Prechool Children

Authors	Age Range (Mean ± SD)	N/n < 6 years	Diagnostic Procedure for Eligibility	Medication/Dose	Study Design/Duration	Outcome Assessment (for ADHD and disruptive behaviors)	Study Outcome	Side Effects/Safety
Cohen et al., 1981	Kindergarten aged1	24/24	Clinical interview, Connors' Rating Scale-Teacher (CRS-T)	MPH 10–30 mg/day	Three randomized parallel groups (MPH, Cognitive Behavior Management [CBM], and CBM + MPH), open-label treatment/10 weeks	Cognitive and motor impulsivity tasks, parent and teacher behavior rating scales, classroom observation	No treatment effect in any of the groups	4 of the 14 (29%) children on MPH stopped medication due to side effects and were reassigned to either CBT or no treatment
Alessandri & Scharmm, 1991	50 months	1/1	Clinical interview, Connors' Rating Scale-Parent (CRS-P)	DEX 2.5 mg bid	Open-label A-B-A-B reversal design/16 weeks	Blinded ratings of off-task behavior, level of cognitive play and social participation during structured activity and unstructured play; teacher rated PBQ, CRS-T	↓ off-task behavior, ↑ attention, ↑ developmentally appropriate goal-directed, organized and symbolic play, & improved social functioning on direct observation ratings of behavior during structured activity and unstructured play	↑ solitary & parallel play
Byrne et al., 1998	62 months1	8/8	Clinical interview, Continuous Performance Test for Preschoolers—Visual (CPTP-V), CPT-Auditory (A), CRS-P, CBCL	MPH 15–20 mg/day or DEX 7.5–15 mg/day on qd-tid schedule	Open-label/5 months	CPTP-V, CPT-A, CRS-P, Child Behavior Check-list (CBCL)	↑ attention & social relations, ↓ problem behaviors	No information
Stiefel & Dossetor, 1998	5 years	1/1	Clinical interview	DEX 5 mg bid	Open-label/4 years	Clinical assessment	Improved behavior	Initial problem with reduced appetite and getting to sleep ameliorated with time
Ghuman et al., 2001	40–70 months (56.4 ± (9.6 months)	27/27	Clinical interview	MPH 0.55 mg/kg/day or DEX 0.43 mg/kg qd-qid	Chart review/24 months	Clinical Global Impressions-Severity (CGI-S) and CGI-Improvement	74% experienced improvement at 3 months and 70% at 12 and 24 months	63% experienced side effects; poor appetite, stomachache, irritability, dysphoria, sleep disturbance, headache, dull/tired; 11% stopped stimulants due to side effects

¹Mean age not provided.

MPH = methylphenidate; DEX = dextroamphetamine.