Clonidine for attention-deficit/hyperactivity disorder: I. Efficacy and tolerability outcomes.
OBJECTIVE
To determine the efficacy and safety of clonidine, used alone or in combination with methylphenidate, in treating attention-deficit/hyperactivity disorder (ADHD).


METHODS
A 16-week, randomized, double-blind, placebo-controlled clinical trial was conducted in 122 children, ages 7 to 12, with any subtype of ADHD, randomly assigned to clonidine, methylphenidate, clonidine in combination with methylphenidate, or placebo according to a 2 x 2 factorial design. In two successive 4-week titration periods, clonidine (or matching placebo) and added methylphenidate (or matching placebo) were adjusted to optimal doses and then continued for 8 weeks. The primary efficacy outcome was changed from baseline to week 16 on the Conners Teachers Abbreviated Symptom Questionnaire. Secondary outcomes included the Conners Abbreviated Symptom Questionnaire for Parents and the Children's Global Assessment Scale.


RESULTS
On the Conners Teachers Abbreviated Symptom Questionnaire, clonidine was not found to improve ADHD symptoms, whereas subjects treated with methylphenidate showed significant improvement compared to those not treated with methylphenidate. Subjects treated with clonidine had greater improvements on the Conners Abbreviated Symptom Questionnaire for Parents and Children's Global Assessment Scale, but also a higher rate of sedation compared with subjects not treated with clonidine.


CONCLUSIONS
Based on the Conners Teachers Abbreviated Symptom Questionnaire, methylphenidate offers the best combination of efficacy and tolerability for ADHD. Clonidine was well tolerated despite the frequency of sedation and did offer some benefit.
Palumbo
Donna R
DR
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
Sallee
Floyd R
FR
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.. Electronic address: floyd.sallee@uc.edu.
Pelham
William E
WE
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
Bukstein
Oscar G
OG
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
Daviss
W Burleson
WB
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
McDERMOTT
Michael P
MP
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
Drs. Palumbo and McDermott are with University of Rochester; Dr. Sallee is with University of Cincinnati; Dr. Pelham is with State University of New York at Buffalo; Dr. Bukstein is with University of Pittsburgh; and Dr. Daviss is with University of Texas Health Science Center at San Antonio.
D000316:Adrenergic alpha-Agonists / Q000009:adverse effects / Q000627:therapeutic use*; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D000697:Central Nervous System Stimulants / Q000009:adverse effects / Q000627:therapeutic use; D002648:Child; D003000:Clonidine / Q000009:adverse effects / Q000627:therapeutic use*; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008774:Methylphenidate / Q000009:adverse effects / Q000627:therapeutic use; D010552:Personality Assessment; D012931:Social Environment; D016896:Treatment Outcome
D000316:Adrenergic alpha-Agonists; D000697:Central Nervous System Stimulants; D008774:Methylphenidate; D003000:Clonidine