A new multicenter study says that lithium, a drug typically given only to adults, is safe and effective for children and adolescents who have bipolar disorder.
The study, led by a researcher at the Johns Hopkins Children's Center and published Oct. 12 in Pediatrics, affirms what clinicians who prescribe this drug have observed for years and suggests that doctors can now more confidently add lithium to the available treatments for this vulnerable population -- at least in the short term, the authors say.
Lithium is one of the oldest drugs for bipolar disorder, a chronic brain condition marked by spontaneous, seesawing bouts of abnormally high moods and depression. The drug's ability to stabilize mood extremes has been well established in adults.
The researchers point out that historically, children and women of childbearing age have generally been excluded from many clinical trials out of an abundance of caution. Some believe that while the intentions may have been good, being excluded in clinical studies may actually harm this population- leaving them without access to more effective treatments.
"Lithium is the grandfather of all treatments for bipolar disorder, but it has never been rigorously studied in children," says Robert Findling, M.D., M.B.A., a professor of psychiatry and behavioral sciences at the Johns Hopkins University School of Medicine and director of child and adolescent psychiatry at the Johns Hopkins Children's Center.
Findling initiated the work while director of child and adolescent psychiatry at Case Western Reserve University School of Medicine.
Though medications used to treat schizophrenia and other psychoses are prescribed to treat bipolar disorder in children, Findling says, those drugs have been linked to substantial weight gain, a considerable medical and social drawback for young people that causes many to stop taking them.
Results from the study showed that the patients on lithium experienced far more significant improvement in their symptoms over eight weeks compared with those on the placebo. Some 47 percent of those on lithium scored in the range of "very much improved" or "much improved" on the Clinical Global Impressions Scale, a rating system commonly used to assess the efficacy of treatments in patients with mental disorders, compared to 21 percent of those on the placebo.
Unlike antipsychotic agents, such as risperidone or olanzapine, lithium treatment was not associated with significant weight gain, and none of the patients experienced serious side effects due to the lithium treatment.
Findling says the findings provide a scientific and reliable confirmation of lithium's efficacy and safety for children in the short term, offering evidence that doctors can use when deciding what medication to prescribe their pediatric patients with bipolar disorder. Further analyses are currently in progress to examine the long-term implications of lithium use, he adds. Areas of particular focus include evaluation of any potential side effects, such as weight gain, reduced kidney function or diminished thyroid function -- all important considerations, as those with bipolar disorder may need a lifetime of medication and behavioral therapies.
Bipolar disorder affects approximately 1 percent of teens and is the leading cause of disability in adolescence.
Source: Adapted Media Release, http://www.medicalnewstoday.com/releases/300847.php