title: Safety and tolerability of desvenlafaxine in children and adolescents with major depressive disorder.
abstract: OBJECTIVE
  The purpose of this study was to assess long-term safety and tolerability of desvenlafaxine (administered as desvenlafaxine succinate) in children and adolescents with major depressive disorder (MDD).
  
  
  METHODS
  An 8 week, multicenter, open-label, fixed-dose study of children (ages 7-11 years) and adolescents (ages 12-17 years) with MDD was followed by a 6 month, flexible-dose extension study. Patients were administered desvenlafaxine 10-100 mg/day (children) or 25-200 mg/day (adolescents) for a total of 8 months. Treatment-emergent adverse events (AEs), withdrawals because of AEs, laboratory tests, vital signs, and the Columbia Suicide-Severity Rating Scale (C-SSRS) were collected. Eight month safety results from the lead-in plus extension studies are reported for extension study participants, using lead-in study day -1 as baseline.
  
  
  RESULTS
  Forty patients were enrolled in both studies (20 children; 20 adolescents). Of those, four children and three adolescents withdrew because of AEs. Treatment-emergent AEs reported by three or more patients were upper abdominal pain (15%) and headache (15%) in children, and somnolence (30%), nausea (20%), upper abdominal pain (15%), and headache (15%) in adolescents. Negativism (oppositional behavior) in a child was the single serious AE reported. No deaths occurred during the lead-in or extension studies. Mean pulse rates demonstrated statistically significant increases from lead-in study baseline to final evaluation (children, +5.2 bpm; adolescents, +5.9 bpm; p≤0.05). No statistically significant change in blood pressure was observed at final evaluation. Two adolescents (0 children) reported suicidal ideation on the C-SSRS at screening assessment and during the lead-in and/or extension trials; one adolescent reported suicidal ideation after screening only.
  
  
  CONCLUSIONS
  Long-term (8 month) treatment with desvenlafaxine was generally safe and well tolerated in depressed children and adolescents.
authors.affiliation: 1 Johns Hopkins University , Baltimore, Maryland.
authors.forename: Robert L
authors.initials: RL
authors.lastname: Findling
authors.forename: James
authors.initials: J
authors.lastname: Groark
authors.forename: Deborah
authors.initials: D
authors.lastname: Chiles
authors.forename: Sara
authors.initials: S
authors.lastname: Ramaker
authors.forename: Lingfeng
authors.initials: L
authors.lastname: Yang
authors.forename: Karen A
authors.initials: KA
authors.lastname: Tourian
mesh_terms: D000293:Adolescent; D000928:Antidepressive Agents / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D002648:Child; D003511:Cyclohexanols / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D003865:Major Depressive Disorder / Q000188:drug therapy*; D000069468:Desvenlafaxine Succinate; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008297:Male; D012720:Severity of Illness Index; D059020:Suicidal Ideation; D013997:Time Factors
chemical_list: D000928:Antidepressive Agents; D003511:Cyclohexanols; D000069468:Desvenlafaxine Succinate