ECT was projected to reduce time with uncontrolled depression from 50 to 33 to 37% of life-years over 4 years; greater improvements were seen when ECT was offered earlier.
In both studies, the primary efficacy endpoint was change from baseline to Day 28 in Montgomery-Åsberg Depression Rating Scale (MADRS) total score.
Compared to placebo, selective serotonin reuptake inhibitors (SSRIs) were associated with a significantly higher risk of headache (risk ratio [RR] 1.06, 95% CI: 1.00 to 1.13; P =.045).
The approval was based on data from the 8-week, randomized, double-blind, placebo-controlled studies, FOCUS and CONNECT, which investigated the effect of Trintellix on various aspects of cognitive function among adults aged 18 to 65 years with depression.
Results in the 202B and 202C trials showed that brexanolone achieved the primary endpoint of mean reduction from baseline in the Hamilton Rating Scale for Depression.
ALKS 5461 consists of a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist.
To determine the prevalence of DSM-5 MDD as well as DSM-5 specifiers, the study authors conducted "in-person interviews with a representative sample of US noninstitutionalized civilian adults (≥18 years) (n = 36 309) who participated in the 2012-2013 National Epidemiologic Survey on Alcohol and Related Conditions III (NESARC-III)."
Study quality was graded according to the United States Preventive Services Task Force and the Cochrane Risk of Bias Tools.
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.