FDA approves Abilify for adolescents with schizophrenia

November 27, 2007

Based on the recent multinational study showing a significant benefit for adolescents with schizophrenia, the FDA has approved aripirazole (Abilify) for kids aged 13 to 17. The study showed significant improvements over placebo, and a discontinuation rate of only about 4% over six weeks.

In that clinical study involving more than 300 adolescents in 13 countries, the most common side effects were extrapyramidal symptoms and drowsiness. About 5% of the teens gained at least 7% over their baseline weight.

The action closely follows approval of risperidone for kids with schizophrenia only two months ago.

Learn more quickly with SearchMedica’s content categories:

Practical Articles and News
Find guidance for encouraging adherence despite body-image issues in young schizophrenia patients.

Clinical Trials for Patients
A new clinical trial (but not for adolescents) is comparing Abilify head-to-head with injectable Risperdal to test the effects on adherence. (The hypothesis favors Risperdal).

No Comments » | Adolescent, Nervous System, Schizophrenia | Tagged: , , , | Permalink
Posted by Cranky Aged Mama

SSRI Rxs for youth drop. Suicides rise. Coincidence?

October 1, 2007

Close on the heels of news from the CDC that youth suicides are up for the first time in 15 years come the results of a new study that explicitly links this increase with a decline in antidepressant prescriptions.

After the FDA and European authorities issued warnings that blamed SSRIs for suicidal thoughts, a multicenter team tracked SSRI prescriptions for adolescents and children with corresponding suicide rates in both the Netherlands and the U.S.

“If the intent of the pediatric black box warning was to save lives, the warning failed,” the authors contend. Suicide rates in both countries rose afterwards—and most obviously among children and adolescents, whose antidepressant use dropped sharply.

The FDA based its decision on a meta-analysis of studies involving non-fatal suicide attempts. Did this overlook a much higher rate of completions among kids not taking part in clinical trials?

A recent re-analysis of the same data found the suicide risk much lower for children taking SSRIs.

Clinically Useful Categories

Practice Guidelines
Authors of the new study suggest that better education of clinicians would be preferable to hasty black box warnings. Review current guidelines about treating depressed adolescents.

Clinical Trials for Patients
Find clinical trials that may offer the safest way to try antidepressants for adolescents in the current situation.

No Comments » | Depression, Pediatrics | Tagged: , , , | Permalink
Posted by Cranky Aged Mama