A Randomized Double-Blind Trial of Paroxetine and/or Dextroamphetamine and Problem-Focused Therapy for Attention-Deficit/Hyperactivity Disorder in Adults.
J Clin Psychiatry 2006;67(4):611-619
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Objective: To determine the effect of
psychotherapy, dextroamphetamine, and/or paroxetine on
attention-deficit/hyperactivity-disorder (ADHD) in adults.
Method: Ninety-eight adults with DSM-IV
ADHD were randomly assigned to receive psychotherapy
and dextroamphetamine, paroxetine, both, or placebo for
20 weeks. A 2x2 factorial design compared patients
who received dextroamphetamine versus no
dextroamphetamine with patients who received paroxetine versus
no paroxetine. Data were collected from August
2000 until May 2002.
Results: One half of the 98 enrolled subjects
were found to have at least 1 lifetime mood or anxiety
disorder on the Structured Clinical Interview for
DSM-IV. Sixty percent of patients who received medication
and 80% of those who received placebo completed the
5-month trial. ADHD symptoms were significantly (p = .012) lower in patients in the completer group
who received dextroamphetamine. Paroxetine had no
effect on ADHD. Hamilton Rating Scales for Anxiety
(HAM-A) and Depression (HAM-D) scores were low
to start, and no treatment differences were evident
at endpoint. Significantly (p < .001) more patients in
the completer group were rated by clinicians as ADHD
responders if they received dextroamphetamine
(85.7%) or combined treatment (66.7%) versus
paroxetine (20.0%) or placebo (21.1%). Significantly
(p = .003) more patients in the completer group were rated by
clinicians as mood/anxiety responders if they
received paroxetine (100%) or combined treatment (73.3%)
versus those receiving dextroamphetamine (57.15%)
or placebo (47.4%). Clinicians rated any patient
who received medication and psychological therapy as
significantly more improved overall than those who
received placebo and psychological therapy (intent
to treat: p = .033; completers: p = .001).
Conclusion: ADHD symptoms improved with
dextroamphetamine. Mood and internalizing symptoms were seen as improved with paroxetine by
clinicians, despite absence of response on the HAM-A and
HAM-D. The presence of a lifetime internalizing disorder
attenuated the response to dextroamphetamine.
Patients who received both dextroamphetamine and
paroxetine had more severe adverse events but did not show
greater improvement overall than patients treated with 1
medication. Clinical Trials Registry #GSK707.