Long-term treatment with lurasidone, an atypical antipsychotic marketed by Sunovion as Latuda, is effective in improving depressive symptoms of bipolar 1 depression in pediatric patients, according to a recent research presented at the American Psychiatric Association (APA) 2018 annual meeting held from May 5-9, in New York City.
Lurasidone is already in use for the treatment of bipolar depression in adults as monotherapy and adjunctive therapy with lithium or valproate in the United States. It is also approved for treating adolescents and adults diagnosed with schizophrenia. According to Sunovion Pharmaceuticals Inc., the U.S. Food and Drug Administration’s (FDA) approved the supplemental New Drug Application (sNDA) that will help expand the usage of Latuda to treat major episodes of depression associated with bipolar I disorder in pediatric patients aged 10 to 17.
6-week clinical trial reveals Latuda’s effectiveness for bipolar disorder in youth
The FDA’s approval for Latuda’s expanded indication was based on a Phase 3 clinical study of pediatric patients (10-17 years of age) suffering from bipolar depression. In the study, patients were randomly given double-blind treatment with lurasidone or placebo for six weeks. Patients who completed the treatment further enrolled for a two-year open-label extension study to continue lurasidone at 20 mg/day.
The results showed Latuda to lead to statistically important and clinically significant improvement in bipolar depression symptoms compared to placebo, based on the primary efficacy endpoint of change from baseline to week six on the Children’s Depression Rating Scale, Revised (CDRS-R) total score.
“With limited approved treatment options for these patients, the FDA approval of Latuda marks an important milestone for the mental health community,” explained David Frawley, executive vice president and chief commercial officer at Sunovion.
In the study, Latuda was mostly well-tolerated. The most common side effects reported were nausea, weight gain and insomnia. No abnormalities were noted in glucose, triglycerides, cholesterol, or blood pressure levels during the treatment.
About Bipolar Disorder
Bipolar disorder is characterized by uncommon shifts in mood and energy levels, often resulting in an inability to carry out everyday tasks. In the long run, such expressions can end up as lifetime mental conditions, making matters more complex for patients struggling with the illness.
According to the National Institute of Mental Health (NIMH), Bipolar I Disorder is marked by manic episodes that persists for at least seven days, or by manic signs so severe that a patient may need instant hospital care. According to NIMH reports, an estimated 4.4 percent of U.S. adults experience bipolar disorder at some point in their lives.
People struggling from bipolar disorder experience phases of remarkably intense emotion, sleep disturbance, fluctuations in activity levels, and display weird behaviors. These upheavals in mood referred to as mood episodes are often characterized as depressive or hypomanic. It is not unusual for a person with this disorder to have periods of normal mood in between depressive episodes. Though bipolar disorder has no cure, the symptoms can very well be treated provided early medical intervention is given to the patients. The treatment generally combines medication, psychotherapy, cognitive behavioral therapy, psychoeducation and support groups.
Dealing with bipolar disorder
Although bipolar disorder is a severe condition, treatment can help people manage the symptoms with good effect. If you have a loved one exhibiting signs of bipolar disorder, it is important to seek immediate help from a credible treatment center.
White River Academy, a leading therapeutic boarding school for boys aged 12 to 17 years, offers a multi-faceted approach for treating bipolar disorder in teens at its state-of-the-art center in Utah. Call at our 24/7 helpline or chat online with our one of our experts to know more about the best treatment for teen bipolar disorder.