Table 1.

Double-blind, placebo-controlled, clinical trials of clonidine in children and adolescents with ADHD

Authors	Subjects enrolled (completed)	Design	CLO daily dose	Efficacy measures	Safety measures	Efficacy	Side effects
Jain et al15	236 (143)	8-week, two dosage CLO ER groups versus placebo	0.2 mg, 0.4 mg	Multiple ADHD RS and psychological tests by researchers and parents	Clinical report, ECG, VS, laboratory tests	Significantly greater improvement in both CLO ER dosage groups versus placebo	Somnolence Fatigue
Kollins et al16	198 (165)	8-week, CLO ER add-on versus placebo	Escalating doses, max 0.4 mg	Multiple ADHD RS and psychological tests by researchers and parents	Clinical report, ECG, VS	CLO ER efficacious as an add-on in children with partial response to stimulants	Somnolence Headache Fatigue
Palumbo et al17	122 (78)	16-week, CLO, MLP, CLO + MLP, placebo	Mean 0.24 ± 0.11 mg Max 0.6 mg	ADHD RS by teachers and parents	Clinical report, ECG, VS	CLO better than placebo by parents reports, but not by teachers’ reports	Sedation
Daviss et al18	122	16-week, CLO, MLP, CLO + MLP, placebo	Titration max 0.6 mg	N/A	Clinical report, Pittsburgh side effect RS, ECG, VS	N/A	Somnolence Nervousness Bradycardia
Cannon et al19	122 (84–99)	16-week, CLO, MLP, CLO + MLP, placebo	Mean 0.24 ± 0.11 mg Max 0.6 mg	Questionnaires by parents and ADHD RS by researchers	N/A	CLO + MLP better than placebo	N/A

Abbreviations: ADHD, attention deficit and hyperactivity disorders; CLO, clonidine; ECG, electrocardiogram; ER, extended-release; max, maximum; MLP, methylphenidate; N/A, not available; RS, rating scales; ECG, electrocardiogram; VS, vital sign.