A recent clinical trial showed that a therapy called OFC––olanzapine (Zyprexa)/fluoxetine (Prozac) combination, was significantly superior to placebo for treating the acute depression associated with bipolar-I disorder in children and adolescents. The finding is especially promising news for young people with bipolar-I disorder in which mood cycles between depression and mania or hypomania. Effective treatments for the depressive phase of the illness are few and far between.

Melissa DelBello, M.D., of the University of Cincinnati, and her colleagues conducted the study, which was published December 29th in the Journal of the American Academy of Child & Adolescent Psychiatry. Dr. DelBello received NARSAD Young Investigator grants in 2001 and 2004; in 2006 she received an Independent Investigator grant. Her team tested OFC for eight weeks in a clinical trial in which 255 patients between the ages of 10 and 17 took part. The children were divided into two groups: one group received OFC; the other group received a placebo (a look-alike pill with inactive ingredients).

Given the developmental, social, and emotional challenges that adolescents already face, it is critical that their depression be treated with effective medication. But when antidepressants alone are prescribed, manic symptoms can become worse. And although there are many medications available to treat the manic phase of bipolar disorder, treatments for the depressive phase remain understudied. To date, only two clinical trials of medication specifically for bipolar depression have been conducted in children and adolescents. Neither has shown significant benefit compared to placebo.

The main side effects of OFC were weight gain and higher cholesterol when compared to the placebo group, as well as a slightly higher incidence of changes in an aspect of heart rhythm, compared to adults treated with OFC. Although the team says clinicians should be mindful of these potential side effects when prescribing, they consider the study results encouraging, suggesting that OFC is an effective treatment for adolescents with depression associated with bipolar-I disorder.

This was the first clinical trial to study this drug combination in patients younger than 18. Previously, fluoxetine has been shown to be effective for depression in children and adolescents, and olanzapine has been shown to be effective for treating schizophrenia and manic or mixed episodes in adolescents.



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