The Company stated that they plan to begin a Phase 2 trial of AXS-12 before the end of 2018, with results anticipated for the first half of 2019.
SUNRISE 2 is an ongoing long-term efficacy and safety study (N=900) of adults (aged 18 to 88 years) with insomnia disorder who have difficulty falling and/or staying asleep.
Compared with the active placebo, the infusions of ketamine were relatively well tolerated, except for greater dissociative symptoms and transient blood pressure elevations with the higher doses.
Among women not taking antihypertensives, sexual harassment was correlated with significantly increased odds of stage 1 or 2 hypertension (odds ratio, 2.36) as well as clinically poor sleep (odds ratio, 1.89) after adjustment for covariates.
The patient obtained prescriptions for bupropion XR from psychiatrists and primary care physicians who were not aware of her past medical history.
Higher risk for psychiatric diagnoses was predicted by high average HbA1c levels during the first 2 years of diabetes onset.
The researchers found that the mean number of guidelines met was 1.1; 51, 37, and 18% of participants met the daily recommendations for sleep time (9 to 11 hours/night), screen time (2 hours or less), and physical activity (60 minutes or more), respectively.
Lumateperone, a first-in-class molecule, works via potent interactions at 5-HT2A receptors, serotonin transporters, and D1 receptors with indirect glutamatergic modulation.
Currently, psilocybin, a serotonin receptor agonist, is classified as a Schedule I agent as it has not been approved by the Food and Drug Administration (FDA) for any therapeutic use.
The sNDA included findings from the RGH-MD-53, RGH-MD-54, and RGH-MD-56 trials in which cariprazine was associated with greater improvement in change from baseline to week 6 on the Montgomery Asberg Depression Rating scale (MADRS) total score vs placebo in bipolar I patients.
The primary outcome measure of the study was the frequency of any adverse psychiatric effect observed during treatment with one of these agents.
The researchers found that a high-risk anticholinergic prescription was listed for 6.2% of visits of older adults between 2006 and 2015, representative of 14.6 million total visits nationally.
Based on the data, the FDA has concluded that the drug's benefit continues to outweigh its risks for patients with hallucinations and delusions associated with Parkinson's disease psychosis.
A report from the Department of Health and Human Services (HHS) found that 1 in 3 foster children sampled in 5 states received the drugs without treatment plans or follow-up.
The researchers found that 26.4% of adults met the definition of long-term use 1 year after the index prescription; they were prescribed a mean of 232.7 benzodiazepine days.
While pharmacologic agents such as lithium and valproic acid have been shown to provide significant antimanic effects in older adults with bipolar disorder, an increase in the use of atypical antipsychotics in the general adult bipolar population prompted researchers to investigate the efficacy and tolerability of these agents in OABD.
In this meta-analysis of available studies, physician burnout was linked to an increased risk of patient safety incidents, professionalism issues, and reduced patient satisfaction.
The 5 topics addressed by the 11-member expert panel include epidemiology, clinical presentation, therapeutic effects of antidepressants, effects of hormone therapy, and the effectiveness of other therapies (eg, psychotherapy, exercise, natural health products).
The NDA includes five Phase 3 studies in patients with treatment-resistant depression: 3 short-term studies, 1 withdrawal maintenance of effect study, and 1 long-term safety study.
The researchers found that in 2015, SIM surpassed diabetes as a cause of death in the United States. In 2016, the gap expanded, with rates of 29.1 and 24.8 per 100,000 population, respectively.
The researchers found that by age 27 years, 19.8% of individuals diagnosed with ASD had a diagnosis of depression, compared with 6.0% among the general population (adjusted relative risk [RR], 3.64).
The FDA stated that the dasotraline NDA cannot be approved in its current form and is requiring additional data to further assess the efficacy and tolerability of the drug.
A comparative dosing and titration chart of commonly used first-generation and second-generation antipsychotics.
A comparative list of psychotropic medications with their mood disorder indications (bipolar disorder, major depressive disorder, treatment resistant depression, premenstrual dysphoric disorder, and others).
With regard to safety, treatment with lithium in this patient population was considered "generally safe, at least in the short term."
The trial will be a Phase 2b dose-ranging study (N=216) with patients from 12-15 research centers across Europe and North America.