Clonidine for Attention-Deficit/Hyperactivity Disorder: I. Efficacy and Tolerability Outcomes - 01/11/17
, WILLIAM E. PELHAM, Ph.D., OSCAR G. BUKSTEIN, M.D., W. BURLESON DAVISS, M.D., MICHAEL P. McDERMOTT, Ph.D.THE CAT STUDY TEAM
ABSTRACT |
Objective: |
To determine the efficacy and safety of clonidine, used alone or in combination with methylphenidate, in treating attention-deficit/hyperactivity disorder (ADHD).
Method: |
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 × 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.
Le texte complet de cet article est disponible en PDF.Key Words: : attention-deficit/hyperactivity disorder, clonidine, methylphenidate, clinical trials
Plan
| Editorship of Mina K. Dulcan, M.D. Members of the CAT Study Team are listed at the end of the article. This project was supported by NINDS grant 5R01 NS039087 (Dr. Sallee). Additional NIH support came from K23 MH065375 (Dr. Daviss) and K24 AA000301 (Dr. Bukstein). Clinical trial registration information-URL:www.clinicaltrials.gov. Unique identifier: NCT00031395. Disclosure: Dr. Palumbo is on the ADHD Advisory Board and the speakers’ bureau of McNeil Consumer and Specialty Pharmaceuticals; is a scientific consultant to and principal investigator for Pfizer; is a site investigator for Shire, Noven, Eli Lilly, Organon, and Cephalon; and has received educational grant support from Novartis, McNeil, and Celltech/UCB. Dr. Sallee is a consultant to Shire and Otsuka. Dr. Bukstein is on the speakers’ bureaus of McNeil Consumer and Specialty Pharmaceuticals, Shire, and Novartis; is a consultant to Shire, Cephalon, and Forest Research Institute; and receives funding support from Shire, Eli Lilly, and Sanofi Aventis. Dr. Daviss is on the speakers’ bureau of Shire Pharmaceuticals. The other authors report no conflicts of interest. |
Vol 47 - N° 2
P. 180-188 - février 2008 Retour au numéro
Article précédent
- Prospective Assessment of Cannabis Withdrawal in Adolescents With Cannabis Dependence: A Pilot Study
- ROBERT MILIN, IAN MANION, GLENDA DARE, SELENA WALKER
- Clonidine for Attention-Deficit/Hyperactivity Disorder: II. ECG Changes and Adverse Events Analysis
- W. BURLESON DAVISS, NICK C. PATEL, ADELAIDE S. ROBB, MICHAEL P. McDERMOTT, OSCAR G. BUKSTEIN, WILLIAM E. PELHAM, DONNA PALUMBO, PETER HARRIS, FLOYD R. SALLEE, THE CAT STUDY TEAM
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