Venlafaxine in the treatment of children and adolescents with attention-deficit/hyperactivity disorder.
OBJECTIVE
The objectives of this pilot study were to explore the changes in symptom severity, tolerability, and the pharmacodynamics of venlafaxine treatment in youths with attention-deficit/hyperactivity disorder (ADHD).


METHODS
This was a 2-week, open-label, outpatient trial of venlafaxine in children and adolescents, ages 5-17 years, with ADHD. Three dosing strata, 0.5, 1.0, and 2.0 mg/kg per day, were examined. ADHD symptom severity and improvement assessments included the ADHD Rating Scale (ARS-IV) and the Clinical Global Impressions Scale (CGI). During this study, venlafaxine, O-desmethylvenlafaxine (ODV), norepinephrine, and serotonin concentrations were obtained.


RESULTS
Thirty-eight participants (33 males) were treated in this trial. Overall, parent-completed and teacher-completed ARS-IV total scores showed a statistically significant positive change at the end of the study when compared to baseline (p < 0.05). Significant increases in plasma venlafaxine concentrations were observed at day 15 when compared to day 8 (p = 0.04). In addition, plasma norepinephrine and serotonin concentrations were found to be significantly decreased from baseline at end of study (p < 0.05). Four patients ended participation in the study prematurely: lost to follow up (n = 2), withdrawal of consent (n = 1), and worsening of ADHD symptoms after 8 days of treatment (n = 1). There were no discontinuations due to other adverse events.


CONCLUSIONS
Venlafaxine appeared to offer some benefit and appears to be relatively safe for the short-term treatment of ADHD in this open-label trial. The pharmacodynamics of venlafaxine in youths are consistent with serotonergic and neuradrenergic modulation.
Findling
Robert L
RL
Department of Psychiatry, University Hospitals Case Medical Center, Cleveland, Ohio 44106-5080, USA. robert.finding@UHhospitals.org
Greenhill
Laurence L
LL
McNamara
Nora K
NK
Demeter
Christine A
CA
Kotler
Lisa A
LA
O'Riordan
Mary Ann
MA
Myers
Carolyn
C
Reed
Michael D
MD
D000293:Adolescent; D001289:Attention Deficit Disorder with Hyperactivity / Q000188:drug therapy*; D002648:Child; D003511:Cyclohexanols / Q000008:administration & dosage* / Q000009:adverse effects / Q000097:blood / Q000493:pharmacokinetics; D000069468:Desvenlafaxine Succinate; D004305:Dose-Response Relationship, Drug; D005178:Faculty; D005260:Female; D006801:Humans; D008297:Male; D009638:Norepinephrine / Q000378:metabolism; D010290:Parents; D010865:Pilot Projects; D011569:Psychiatric Status Rating Scales; D011594:Psychometrics; D012701:Serotonin / Q000378:metabolism; D017367:Selective Serotonin Reuptake Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics; D012720:Severity of Illness Index; D000069470:Venlafaxine Hydrochloride