Randomized, placebo-controlled, multicenter, parallel-design,
275 male and female adolescents ages 12-18 with major depression,
diagnosed by clinical interview, DSM-IV criteria, symptom duration
of >8 weeks, Hamilton Rating Scale for Depression score >12/17,
Children's Global Assessment Scale score < 60, and Peabody
Picture Vocabulary Test > 80.
Excluded were those with co-existing DSM-IV diagnoses such as
bipolar, schizoaffective, and substance abuse disorders, as well
as those with current suicidal ideation with intent or plan, recent
trial of antidepressant medication, or pregnancy.
8 week study, only 69% follow-up (losses accounted for by adverse
reactions and protocol violation especially). Withdrawal rates
for adverse events were 9.7% in paroxetine group and 6.9% in placebo
3 arms of study: 1) paroxetine 20-40mg/day 2) imipramine 50-300mg/day
Adverse effects of paroxetine included headache, nausea, dizziness,
dry mouth, somnolence.
Paroxetine separated statistically from placebo at endpoints among
four parameters: response, Hamilton Rating Scale for Depression
depressed mood item, Schedule for Affective Disorders and Schizophrenia
for Adolescents-Lifetime version depressed mood item, and Clinical
Global Impression Score of very much improved or much improved.1