October 13, 2015

Lithium Safe, Effective for Children With Bipolar Disorder

BALTIMORE, Md -- October 13, 2015 -- A multicentre study of young patients with bipolar disorder provides what may be the most scientifically rigorous demonstration to date that lithium can also be safe and effective for children suffering from bipolar disorder.

The study, published in the journal 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.

Historically, children and women of childbearing age have generally been excluded from many clinical drug trials out of an abundance of caution and ethical concerns. However, 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.

Though medications used to treat schizophrenia and other psychoses are prescribed to treat bipolar disorder in children, 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, Robert Findling, MD, Johns Hopkins University School of Medicine, Baltimore, Maryland, and colleagues performed a randomised, placebo-controlled prospective study involving 81 patients seen at 9 academic medical centres across the United States. The participants, split roughly equally between sexes, ranged in age from 7 to 17 years 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, and then gradually increased to a maximum tolerated dose over the next 8 weeks if mood symptoms weren't controlled. The remaining 28 patients received placebo.

At weekly visits for the first 4 weeks, and then every other week for the remainder of the study period, patients' symptoms were assessed using the Young Mania Rating Scale (YMRS), along with other standard assessment tools for bipolar disorder symptoms and therapies. Patients were also questioned about side effects and given a physical exam, including a weight check.

Results showed that the patients on lithium experienced far more significant improvement in their symptoms over 8 weeks compared with those on the placebo. Some 47% of those on lithium scored in the range of “very much improved” or “much improved” on the Clinical Global Impressions Scale, compared with 21% of those on placebo.

In addition, those on lithium dropped nearly 6 more points, on average, in the 60-point YMRS.

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.

Further analyses are currently in progress to examine the long-term implications of lithium use, said Dr. Findling. Areas of particular focus include evaluation of any potential side effects, such as weight gain, reduced kidney function or diminished thyroid function.

SOURCE: Johns Hopkins Medicine
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