Healthcare Professionals

  • Closing the ‘off-label’ gap

    Research puts science behind the use of childhood psychiatric medications.

    When children or adolescents need treatment for bipolar disorder or depression, clinicians may begin with a wide range of therapies from cognitive behavior therapy and psychotherapy to family counseling and relaxation techniques.

    But sometimes children need medications. When they do, child psychiatrists can choose from a number of helpful drugs, but most of those medications must be prescribed on an off-label basis because they have not been tested in children.

    This issue has vexed the entire field of pediatric medicine for years, but now scientists at Cincinnati Children’s are helping to close the pediatric data gap for psychiatric medications. New head-to-head studies are comparing the growing number and types of available medications. More longitudinal studies are delving into how long-term use of psychiatric drugs can affect children as they grow, says Sergio Delgado, MD, a child and adolescent psychiatrist at Cincinnati Children’s.

    “Our medical center has extensive clinical experience. We have more inpatient psychiatric admissions and more outpatient visits than most pediatric hospitals in the country,” Delgado says. “We know we’re helping kids, but now we’re trying to put more science behind it.”

    LAMS study takes long view

    Cincinnati Children’s is one of four centers nationwide involved in the Longitudinal Assessment of Manic Symptoms (LAMS) study, currently in its sixth year. Funded by the National Institute of Mental Health (NIMH), this project tracks long-term outcomes for children who have elevated symptoms of mania—the hallmark of bipolar disorder.

    The study will analyze variations in symptoms, diagnoses, demographics, functioning and outcomes of medication use. About 600 children ages 6 to 12 have been enrolled, including 180 at Cincinnati Children’s. They will be followed for 20 years. Findings from the early phases of the study will be published soon.

    “One of the questions we hope to answer is, ‘How often do childhood symptoms of bipolar disorder last into adulthood?’” Delgado says.

    SPRITES trial evaluates Zoloft

    Sertraline (brand name Zoloft) is FDA-approved for treating adults with major depressive disorder, posttraumatic stress disorder and other conditions. The drug also is approved to treat obsessive-compulsive disorder (OCD) in children ages 6 to 17.

    However, pediatricians and psychiatrists prescribe Zoloft off-label for children for many more conditions than OCD.

    The Sertraline Pediatric Registry for the Evaluation of Safety (SPRITES), opened in August at Cincinnati Children’s, is a multicenter project that expands the study of sertraline to children with other anxiety and depressive disorders.

    “In SPRITES, we will look at more than just whether the medication has a positive effect, but also how the drug might affect the body in other ways, such as height and weight, cognitive and emotional development and pubertal maturation,” Delgado says.

    Head-to-head study of anti-depressants

    In August, Cincinnati Children’s joined a 12-center clinical trial to compare two medications to treat major depressive disorder in children – fluoxetine (Prozac) and desvenlafaxine SR (Pristiq). The study is sponsored by Pfizer, the maker of Pristiq.

    Prozac is the first drug approved by the FDA for treating children with depression. Prozac also is the oldest of a class of drugs called selective serotonin reuptake inhibitors (SSRIs). Pristiq is part of a newer class of drugs called serotonin norepinephrine reuptake inhibitors (SNR Is).

    Some experts say SNR Is are potentially superior to SSRIs because the newer drugs can act upon two neurotransmitters instead of just one. However, Pristiq has not been approved for children, even though it has been approved for adults.

    “Having child-focused data is very important,” Delgado says. “We know that children with depression present differently than adults. And young children present differently than teens. Work is just beginning to determine how response to treatment varies by age.”

    Other projects

    As new medications reach the adult market to treat mood disorders — a category that includes depression and bipolar disorder — Delgado says the volume of head-to-head trials to examine effectiveness in children is destined to grow.

    Cincinnati Children’s recently participated in a controlled trial comparing risperidone (Risperdal) and valproate (Depakote) as treatments for children with bipolar disorder. This study was supported by the NAMI Research Institute/ Stanley Foundation Research Awards Program. A paper detailing the study results is in press, Delgado says.

    From 2009 through 2011, Cincinnati Children’s was part of a large, multisite clinical trial evaluating the use of lithium in children and adolescents with bipolar disorder.

    At a more basic research level, the Division of Psychiatry is working with the Gene Discovery Core at Cincinnati Children’s to gather advanced genomic data about mood disorders.

    Eventually, these research efforts will lead to better-targeted, more effective treatments for children. But in many ways, the work is just beginning.

    “Child and adolescent psychiatry is still in its infancy,” Delgado says. “We’re making rapid progress but we still have much more to do.”

 
  • Medications.

    A collection of medications.

    Medications.