An Open-Label Safety and Pharmacokinetics Study of Duloxetine in Pediatric Patients with Major Depression

• Published in: Journal of child and adolescent psychopharmacology Vol. 22; no. 1; pp. 48 - 55
• Main Authors: Prakash, Apurva, Lobo, Evelyn, Kratochvil, Christopher J., Tamura, Roy N., Pangallo, Beth A., Bullok, Kristin E., Quinlan, Tonya, Emslie, Graham J., March, John S.
• Format: Journal Article
• Language: English
• Published: United States Mary Ann Liebert, Inc 01.02.2012
• Subjects: Adolescent; Antidepressive Agents - administration & dosage; Antidepressive Agents - adverse effects; Antidepressive Agents - pharmacokinetics; Blood Pressure - drug effects; Child; Child & adolescent psychiatry; Depressive Disorder, Major - drug therapy; Dose-Response Relationship, Drug; Duloxetine Hydrochloride; Female; Humans; Kinetics; Male; Mental depression; Psychiatric Status Rating Scales; Psychopharmacology; Severity of Illness Index; Side effects; Suicidal Ideation; Thiophenes - administration & dosage; Thiophenes - adverse effects; Thiophenes - pharmacokinetics; Treatment Outcome

This preliminary, 32-week study assessed the safety, tolerability, and pharmacokinetics of duloxetine in pediatric patients (aged 7-17 years) with major depressive disorder. Patients received flexible duloxetine doses of 20-120 mg once daily, with dose changes made based on clinical improvement and...