Adolescents suffering from major depression were helped more by paroxetine (Paxil) than by another antidepressant, imipramine, or placebo, according to a study which will appear in the July issue of the Journal of the American Academy of Child and Adolescent Psychiatry.
Other studies suggest that over 15 percent of adolescents suffer, at one time or another, from major depression. The course of depression in adolescents is characterized by protracted and frequent depressive episodes. The disorder is associated with high rates of suicide, psychiatric and medical hospitalization, as well as impairment of work, family and social lives.
Despite conflicting evidence of their benefit and high incidence of cardiovascular complications, tricyclic antidepressant drugs have for many years been used to treat depression. Newer drugs called selective serotonin reuptake inhibitors (SSRIs) have been developed with the hope that they will offer a more effective and safer alternative for treating depression. These drugs have been used, largely successfully, in treating depression in adults for over 10 years. They include fluoxetine (Prozac), sertraline (Zoloft), and paroxetine (Paxil).
Martin B. Keller, M.D., of the Department of Psychiatry and Human Behavior at Brown University, and 21 other researchers from across the U.S. and Canada compared the effects of paroxetine and imipramine (a tricyclic antidepressant) to placebo in treating adolescent patients with major depression.
The study, which was conducted at ten medical centers in the U.S. and two in Canada, consisted of 275 adolescents, ages 12 to 18, who were diagnosed with major depression. Each participant underwent a series of 6 tests to establish a baseline score for the severity of depression. Subjects were then randomly assigned to one of three groups. One goup received paroxetine pills (up to 40 mg/day); one received imipramine pills (up to 300 mg/day); and one received placebo. The doses varied for individual cases as deemed necessary by research clinicians. Each group took its assigned pills for 8 weeks. At the completion of the eighth week of treatment, the researchers administered the same regimen of tests used to establish the baseline depression scores and compared the change in scores in the paroxetine and imipramine groups to the placebo group.
The researchers found that after treatment, 66.7 percent of the paroxetine group showed significant improvement in HAM-D scores (the primary measure of depression). Only 58.5 percent of the patients who took imipramine saw such improvement. Unlike paroxetine, the effect of imipramine was not statistically significant compared to the placebo group in which 55.2 percent of patients improved.
Similarly, 65.6 percent of the patients on paroxetine achieved a score of “very much improved” or “much improved” on another test of depression. Again there was no significant difference between the imipramine and placebo group, in which 52.1 percent and 48.3 percent of patients, respectively, achieved these scores.
The researchers found that the paroxetine group achieved statistically significant improvements over the placebo group on four of the six parameters used to measure depression, and “tended toward statistical significance” on the other 2 measures. Conversely, the response to imipramine was not significantly different from that for placebo for any of the tests.
More imipramine patients (31.5 percent) than paroxetine patients (9.7 percent) withdrew from the study due to adverse effects during treatment. Approximately one-third of the adverse effects from imipramine were cardiovascular complications. The most common adverse effects of paroxetine, namely headache, dizziness, and nausea, were less serious.
This is the first study to compare benefit of an SSRI and a tricyclic antidepressant with placebo in treatment of major depression in adolescents. The authors say that the “study demonstrates that treatment with paroxetine results in clinically relevant improvement in depression scores. The SSRIs are the medications of choice for treatment of major depression in adolescents because they are the only agents that have been shown to be efficacious in this population; they have a safer side-effect profile than other antidepressants, particularly in overdose, and they can be administered once daily.”
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