Lithium safe, effective for children with bipolar disorder

A multicenter study of young patients with bipolar disorder provides what may be the most scientifically rigorous demonstration to date that lithium - a drug used successfully for decades to treat adults with the condition - can also be safe and effective for children suffering from it.

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 armamentarium of 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. However, researchers say, although it can also be prescribed for children and teenagers, it has previously not been seriously tested in young people for safety and effectiveness.

Historically, they point out, children and women of childbearing age have generally been excluded from many clinical drug trials out of an abundance of caution and ethical concerns. But in recent years, research guidelines have reflected the belief that excluding such populations may in fact be harming them, because drugs are either withheld or found to behave differently than they do in other groups.

"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.

To test whether lithium is safe and as effective at treating bipolar disorder for children as it is for adults, Findling and his colleagues performed a randomized, placebo-controlled prospective study - the gold standard for clinical research - involving 81 patients seen at nine academic medical centers across the United States. The participants, split roughly equally between sexes, ranged in age from 7 to 17 and had all been diagnosed with bipolar disorder.

After undergoing a "washout" period for those already taking ineffective medication for this condition, 53 children started a regimen of lithium at a standard dose, then gradually increased to a maximum tolerated dose over the next eight weeks if mood symptoms weren't controlled. The remaining 28 patients received placebo.