Long-term, open-label safety and efficacy of atomoxetine in adults with ADHD: final report of a 4-year study.
OBJECTIVE
Previously, data from 97 weeks of open-label atomoxetine treatment of adults with attention-deficit/hyperactivity disorder (ADHD) were reported. This final report of that study presents results from over 4 years of treatment.


METHODS
Results were derived from the study of 384 patients (125 patients remaining in the open-label trial since the interim report), receiving up to 221 weeks of treatment. Primary efficacy measure was the Conners' Adult ADHD Rating Scale-Investigator Rated: Screening Version (CAARS-Inv:SV) Total ADHD Symptom score. Adverse events and vital signs were assessed.


RESULTS
CAARS-Inv:SV Total ADHD Symptom scores decreased 30.2% (p < .001) during treatment. Similar, significant decreases were noted for the secondary efficacy measures, including the Sheehan Disability Scale Total score, which improved 25.3% (p < .001). Adverse events consisted primarily of pharmacologically (noradrenergic) expected effects.


CONCLUSIONS
Results of this open-label study support the long-term efficacy, safety, and tolerability of atomoxetine for the treatment of adult ADHD.
Adler
Lenard A
LA
New York University, School of Medicine, New York, NY 10016, USA. lenard.adler@med.nyu.edu
Spencer
Thomas J
TJ
Williams
David W
DW
Moore
Rodney J
RJ
Michelson
David
D
D018759:Adrenergic Uptake Inhibitors / Q000009:adverse effects / Q000627:therapeutic use; D000328:Adult; D000661:Amphetamine / Q000627:therapeutic use; D000069445:Atomoxetine Hydrochloride; D001289:Attention Deficit Disorder with Hyperactivity / Q000175:diagnosis / Q000188:drug therapy* / Q000523:psychology; D039721:Diagnostic and Statistical Manual of Mental Disorders; D004311:Double-Blind Method; D006801:Humans; D008137:Longitudinal Studies; D008774:Methylphenidate / Q000627:therapeutic use; D010352:Patient Dropouts; D010919:Placebos; D011437:Propylamines / Q000009:adverse effects / Q000627:therapeutic use*; D011569:Psychiatric Status Rating Scales; D012449:Safety; D012720:Severity of Illness Index; D016896:Treatment Outcome
D018759:Adrenergic Uptake Inhibitors; D010919:Placebos; D011437:Propylamines; D008774:Methylphenidate; D000069445:Atomoxetine Hydrochloride; D000661:Amphetamine