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A Randomized Double-Blind Trial of Paroxetine and/or Dextroamphetamine and Problem-Focused Therapy for Attention-Deficit/Hyperactivity Disorder in Adults.
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.