Sertraline in children and adolescents with major depressive disorder.

OBJECTIVE To explore time to first response and time to first persistent response of sertraline versus placebo and compare these parameters between children (6-11 years old, n = 177) and adolescents (12-17 years old, n = 199) with major depressive disorder. METHOD A 10-week placebo-controlled treatment was followed by a 24-week open-label sertraline treatment. The double-blind studies were not powered to detect efficacy differences between age groups. A post hoc analysis explored time to first response and first persistent response using the Children's Depression Rating Scale-Revised and Clinical Global Impressions-Improvement predefined criteria. RESULTS There were no statistically significant differences in time to first response or first persistent response between sertraline and placebo in children, except for time to first response on Clinical Global Impressions-Improvement. Sertraline had a significantly faster time to first persistent response in adolescents compared to placebo. Within treatment groups, children had a significantly faster time to first response than adolescents, whether treated with placebo or sertraline, but not on time to first persistent response. Both age groups showed similar improvement over 34 weeks of treatment. CONCLUSION In the double-blind studies, children and adolescents had different patterns of response with sertraline vs. placebo.

[1]  J. Endicott,et al.  Pediatric Quality of Life Enjoyment and Satisfaction Questionnaire (PQ-LES-Q): reliability and validity. , 2006, Journal of the American Academy of Child and Adolescent Psychiatry.

[2]  D. Safer,et al.  Treatment-emergent adverse events from selective serotonin reuptake inhibitors by age group: children versus adolescents. , 2006, Journal of child and adolescent psychopharmacology.

[3]  M. Rynn,et al.  Long-term sertraline treatment of children and adolescents with major depressive disorder. , 2006, Journal of child and adolescent psychopharmacology.

[4]  J. Racoosin,et al.  Suicidality in pediatric patients treated with antidepressant drugs. , 2006, Archives of general psychiatry.

[5]  R. Findling,et al.  A double-blind, randomized, placebo-controlled trial of escitalopram in the treatment of pediatric depression. , 2006, Journal of the American Academy of Child and Adolescent Psychiatry.

[6]  N. Ryan,et al.  Major depressive disorder in children and adolescents: clinical trial design and antidepressant efficacy. , 2005, The Journal of clinical psychiatry.

[7]  J. March.  Adolescents With Depression—Reply , 2004 .

[8]  Benedetto Vitiello,et al.  Fluoxetine, cognitive-behavioral therapy, and their combination for adolescents with depression: Treatment for Adolescents With Depression Study (TADS) randomized controlled trial. , 2004, JAMA.

[9]  R. Findling,et al.  A randomized, placebo-controlled trial of citalopram for the treatment of major depression in children and adolescents. , 2004, The American journal of psychiatry.

[10]  M. Rynn,et al.  Efficacy of sertraline in the treatment of children and adolescents with major depressive disorder: two randomized controlled trials. , 2003, JAMA.

[11]  K. Wagner,et al.  Fluoxetine for acute treatment of depression in children and adolescents: a placebo-controlled, randomized clinical trial. , 2002, Journal of the American Academy of Child and Adolescent Psychiatry.

[12]  N. Ryan,et al.  Efficacy of paroxetine in the treatment of adolescent major depression: a randomized, controlled trial. , 2001, Journal of the American Academy of Child and Adolescent Psychiatry.

[13]  D. Charney,et al.  Are child-, adolescent-, and adult-onset depression one and the same disorder? , 2001, Biological Psychiatry.

[14]  A. Rush,et al.  Prediction of response to fluoxetine and placebo in children and adolescents with major depression: a hypothesis generating study. , 1999, Journal of affective disorders.

[15]  B. Birmaher,et al.  Summary of the practice parameters for the assessment and treatment of children and adolescents with depressive disorders. American Academy of Child and Adolescent Psychiatry. , 1998, Journal of the American Academy of Child and Adolescent Psychiatry.

[16]  N. Ryan,et al.  Randomized, controlled trial of amitriptyline versus placebo for adolescents with "treatment-resistant" major depression. , 1998, Journal of the American Academy of Child and Adolescent Psychiatry.

[17]  J. Alderman,et al.  Sertraline treatment of children and adolescents with obsessive-compulsive disorder or depression: pharmacokinetics, tolerability, and efficacy. , 1998, Journal of the American Academy of Child and Adolescent Psychiatry.

[18]  S. Stahl,et al.  A double-blind, placebo-controlled study comparing the effects of sertraline versus amitriptyline in the treatment of major depression. , 1997, The Journal of clinical psychiatry.

[19]  A. Rush,et al.  A double-blind, randomized, placebo-controlled trial of fluoxetine in children and adolescents with depression. , 1997, Archives of general psychiatry.

[20]  N. Ryan,et al.  Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version (K-SADS-PL): initial reliability and validity data. , 1997, Journal of the American Academy of Child and Adolescent Psychiatry.

[21]  J. Parker,et al.  The Multidimensional Anxiety Scale for Children (MASC): factor structure, reliability, and validity. , 1997, Journal of the American Academy of Child and Adolescent Psychiatry.

[22]  T. Cooper,et al.  Pharmacokinetically designed double-blind placebo-controlled study of nortriptyline in 6- to 12-year-olds with major depressive disorder. , 1992, Journal of the American Academy of Child and Adolescent Psychiatry.

[23]  T M Itil,et al.  Antidepressant efficacy of sertraline: a double-blind, placebo- and amitriptyline-controlled, multicenter comparison study in outpatients with major depression. , 1990, The Journal of clinical psychiatry.

[24]  J. Stewart,et al.  Use of pattern analysis to identify true drug response. A replication. , 1987, Archives of general psychiatry.

[25]  L. Freeman,et al.  Children's Depression Rating Scale - Revised (September 1984) , 1985 .

[26]  James Robert Brašić,et al.  A children's global assessment scale (CGAS). , 1983, Archives of general psychiatry.