Controlled Study of Mood Stabilizers

Discussion in 'General Parenting' started by Bugsy, Oct 29, 2007.

  1. Bugsy

    Bugsy New Member

    This was sent to me without a link. I copied/pasted it for those interested.

    For those of us with children on Lithium or depakote it is good to see some solid data is in the works.


    Large Controlled Trial of Widely Used Mood Stabilizers Demonstrates Efficacy in Pediatric Bipolar Disorder



    Shows Treatment Significantly Effective at Eight Weeks

    CINCINNATI, Oct. 26 /PRNewswire/ -- In the largest pediatric study of
    its kind on mood stabilizers, scientists from Cincinnati Children's
    Hospital Medical Center and two other centers demonstrated that divalproex
    sodium (Depakote(R)) has efficacy for significantly improving symptoms of
    bipolar I disorder in children and adolescents, according to results
    presented today at the annual meeting of the American Academy of Child and
    Adolescent Psychiatry in Boston.
    Many psychiatric medications prescribed for children and adolescents
    have not been indicated by the FDA for pediatric use. Making sure these
    drugs are effective and safe has been an important goal of pediatric
    psychiatry researchers as well as gaining FDA indications for appropriate
    use in children.
    "Divalproex and lithium are the most widely used mood stabilizers for
    children and adolescents diagnosed with bipolar disorder," said Robert A.
    Kowatch, M.D., Ph.D., a child and adolescent psychiatrist specializing in
    bipolar and other mood disorders at Cincinnati Children's. "Our study now
    proves that these agents definitely work, which may give clinicians and
    families peace of mind."
    Dr. Kowatch presented the eight-week, acute efficacy results from the
    Pediatric Bipolar Collaborative Mood Stabilizer Trial, which also included
    a second, 16-week phase. The investigation is the first controlled trial to
    test and compare lithium and divalproex versus placebo for six months, the
    largest trial of lithium and divalproex to date and first to demonstrate
    efficacy for divalproex in children aged 7 to 17 years, diagnosed with
    bipolar I disorder, mixed or manic, based on standardized criteria.
    Specifically, at the end of an eight-week treatment phase, patients
    receiving divalproex significantly decreased their average scores (p<0.01
    compared to placebo) on the study's primary outcome measure for manic
    symptom severity, the Young Mania Rating Scale (YMRS). Fifty-six percent of
    patients in the divalproex group, 41 percent of those in the lithium group
    and 30 percent of the placebo group experienced a more than 50 percent
    decrease in their YMRS scores (comparisons by treatment group were: p<0.05
    for divalproex vs. placebo, p=0.36 for lithium vs. placebo and p=0.10 for
    divalproex vs. lithium).
    Also, the response rates on the study's other primary outcome measure,
    the Clinical Global Impressions Ratings (CGI) - improvement score,
    indicated that 54 percent of the divalproex group, 42 percent of the
    lithium group and 29 percent of the placebo group improved their CGI scores
    by one or two points, (p<0.05 for divalproex vs. placebo, p=0.26 for
    lithium vs. placebo and p=0.27 for divalproex vs. lithium).
    The National Institute of Mental Health supported the Pediatric Bipolar
    Collaborative Mood Stabilizer Trial via a five-year grant. In addition to
    Cincinnati Children's, other sites involved were Wisconsin Children's
    Hospital and Case Western Reserve University. In the study, investigators
    randomly assigned 153 children to receive a placebo, lithium or divalproex.
    Neither the investigators nor patients knew to which treatment group the
    patients were assigned at the end of the eight week treatment phase. Those
    patients who responded to treatment could continue in the double-blind
    testing for another 16 weeks.
    The classic form of the bipolar illness, also know as bipolar I
    disorder, occurs in children 6 to 17 years. The estimated annual number of
    for U.S. youths aged 19 years and younger receiving a diagnosis of bipolar
    disorder is about 1 percent, based on a 2007 NIH-funded analysis finding
    bipolar diagnoses occurring during 1,003 physician office-based visits by
    this age group per 100,000 population. Symptoms include severe, explosive
    mood swings, euphoria, irritable mood, decreased need for sleep without
    daytime fatigue, pressured speech that is difficult to interrupt, racing
    thoughts, distractibility that varies with mood, increased goal-directed
    activity, hypersexuality and, in some cases, hallucinations. Children with
    the illness are at increased risk of attempting suicide. Bipolar disorder,
    like epilepsy, tends to be a lifelong mecial condition that can be managed
    with medication, psychotherapy and lifestyle changes such as stress
    reduction, regular sleep, accommodations at school and avoidance of
    caffeine, alcohol and drugs of abuse.
    Dr. Kowatch is an internationally known expert for his research in
    child and adolescent bipolar disorders. In 2005, he organized and published
    the now current national treatment guidelines for bipolar I disorder on
    behalf of the Child & Adolescent Bipolar Foundation. The guidelines
    appeared in the March 2005 Journal of the American Academy of Child and
    Adolescent Psychiatry. The recommendations are based on evidence from
    research studies done in children and adults, case reports published in
    medical journals, and consensus by a group of experts as to current
    clinical practices. Further information about pediatric bipolar disorder
    can be found at
    http://www.cincinnatichildrens.org/
    At a Glance:
    -- Largest pediatric study of its kind with mood stabilizers demonstrates
    efficacy for significantly improving symptoms of bipolar I disorder
    -- First controlled trial to test and compare lithium and divalproex
    versus placebo for six months, largest trial of lithium and divalproex
    to date and first to demonstrate efficacy for divalproex in children
    aged 7 to 17 years, diagnosed with bipolar I disorder, mixed or manic.
     
Loading...