The NDA submission is based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials.
"Our results show that, at a population level, prescriptions of stimulants and antidepressant medications for children and adolescents do not appear to be prescribed at rates higher than the known rates for psychiatric conditions they are designed to treat," said the study's lead author, Dr. Ryan Sultan.
The ketamine-treated patients demonstrated a clinically significant reduction in suicidal thoughts compared to the midazolam-treated patients within 24 hours (4.96 points greater reduction in SSI, 95% CI: 2.33, 7.59).
Researchers from the Perelman School of Medicine at the University of Pennsylvania analyzed 66 studies to determine the antidepressant effects of sleep deprivation.
Study authors reported evidence of greater opioid receipt among commercially insured patients with a wide range of psychiatric conditions.
Hyperhidrosis (HH) is associated with increased prevalence of anxiety and depression, in a HH severity-dependent manner, according to a study published in the Journal of the American Academy of Dermatology.
Adding celecoxib to antidepressant therapy may improve its effectiveness in bipolar patients who have been treatment resistant.
U.S. primary care practices use less than one care management process for depression, on average, according to a study published in the March issue of Health Affairs.
The US Preventive Services Task Force (USPSTF) recommends depression screening in the general adult population, including pregnant and postpartum women. These findings form the basis of a final recommendation statement published in the Journal of the American Medical Association.
Cognitive behavioral therapy and antidepressants could both be equally effective as stand-alone treatments for major depressive disorder.
All children should be screened for high cholesterol, depression, and HIV, with some tests starting as early as age 9, according to new guidelines from the American Academy of Pediatrics published online December 7 in Pediatrics.
There may be a link between levels of omega-3 fatty acids and bipolar disorder, according to a small study published in the November issue of Bipolar Disorders.
Breast cancer survivors who take antidepressants while on tamoxifen are not at increased risk for cancer recurrence, according to research published online December 1 in the Journal of the National Cancer Institute.