Academic pressure, intrapersonal and interpersonal difficulties, death of loved ones, illnesses, and loss of relationships, have shown to be significant stressors in young people. While it is a normal part of development in adolescence to experience distressing and disabling emotions, there is an increasing incidence of mental illness globally. This is due mainly because of the breakdown in traditional social and family structures. Depression is usually a response to life events such as relationship issues, financial problems, physical illness, bereavement, etc. Some people can become depressed for no obvious reason and their suffering is just as real as those reacting from life events. Psychological makeup can also play a role in vulnerability to depression. People who have low self-esteem, constantly view themselves and the world with pessimism, or are readily overwhelmed by stress, may be especially prone to depression. Community surveys find that women are more likely than men to say they are under stress. Other studies suggest that women are more likely than men to become depressed in response to a stressful event. Women are also more likely to experience certain kinds of severe stress such as child sexual abuse, adult sexual assaults, and domestic violence. Diagnosis
According to the DSM-IV, children must exhibit either a depressed mood or a loss of interest/pleasure in normal activities. These activities may include school, extracurricular activities, or peer interactions. Depressive moods in children can be expressed as being unusually irritable. These expressions may be displayed by "acting out," behaving recklessly, or reacting with anger/hostility.
History
The approval of pexidartinib was based on the results of a multi-center international clinical trial of 120 subjects, 59 of whom received placebo. The primary efficacy endpoint was the overall response rate (ORR) analyzed after 25 weeks of treatment. The clinical trial demonstrated a statistically significant improvement in ORR in subjects who received pexidartinib, with an ORR of 38%, compared to no responses in subjects who received placebo. The complete response rate was 15% and the partial response rate was 23%. A total of 22 out of 23 responders who had been followed for a minimum of six months following the initial response maintained their response for six or more months, and a total of 13 out of 13 responders who had been followed for a minimum of 12 months following the initial response maintained their response for 12 or more months.The U.S. Food and Drug Administration (FDA) granted the application for pexidartinib breakthrough therapy designation, orphan drug designation, and priority review designation. The FDA granted the approval of Turalio to Daiichi Sankyo. References
Further reading
"Pexidartinib". LiverTox: Clinical and Research Information on Drug-Induced Liver Injury. Bethesda, MD: National Institute of Diabetes and Digestive and Kidney Diseases. October 2019. PMID 31869194. NBK551730. Lamb YN (November 2019). "Pexidartinib: First Approval". Drugs. 79 (16): 1805–1812. doi:10.1007/s40265-019-01210-0. PMC 7044138. PMID 31602563. Roskoski R (February 2020). "Properties of FDA-approved small molecule protein kinase inhibitors: A 2020 update". Pharmacol. Res. 152: 104609. doi:10.1016/j.phrs.2019.104609. PMID 31862477. S2CID 209435035. External links
"Pexidartinib". Drug Information Portal. U.S. National Library of Medicine.