Citation

Atkinson SD, Prakash A, Zhang Q, Pangallo BA, Bangs ME, Emslie GJ, March JS. J. Child Adolesc. Psychopharmacol. 2014; 24(4): 180-189.

Copyright

(Copyright © 2014, Mary Ann Liebert Publishers)

DOI

10.1089/cap.2013.0146

PMID

unavailable

Abstract

OBJECTIVE: The purpose of this study was to evaluate the efficacy and safety of duloxetine flexible dose in children (7-11 years) and adolescents (12-17 years) with major depressive disorder (MDD).

METHODS: Patients (n=337) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine (60-120mg once daily [QD], n=117), fluoxetine (20-40mg QD, n=117), or placebo (n=103). Measures included: Children's Depression Rating Scale-Revised (CDRS-R), treatment-emergent adverse events (TEAEs), and Columbia-Suicide Severity Rating Scale (C-SSRS).

RESULTS: Neither active drug (duloxetine or fluoxetine) separated significantly (p<0.05) from placebo on mean change from baseline to end-point (10 weeks) on the CDRS-R total score. There were no significant differences between the duloxetine or fluoxetine groups compared with placebo on serious AEs (SAEs), total TEAEs, or discontinuation for AE during acute treatment. There were no completed suicides or deaths, and no clinically significant electrocardiogram (ECG) abnormalities observed during the study. One fluoxetine and one duloxetine patient experienced alanine aminotransferase (ALT) three or more times the upper limit of normal, which resolved during the study. A total of 8 (7.1%) duloxetine patients, 7 (6.8%) placebo patients, and 9 (8.0%) fluoxetine patients had worsening of suicidal ideation from baseline during acute treatment. Of the patients with suicidal ideation at baseline, 15/19 (79%) duloxetine, 19/19 (100%) placebo, and 16/19 (84%) fluoxetine had improvement in suicidal ideation at end-point during acute treatment. One duloxetine and two fluoxetine patients had treatment-emergent suicidal behavior during the 36 week study.

CONCLUSION: Trial results were inconclusive, as neither the investigational drug (duloxetine) nor the active control (fluoxetine) separated from placebo on the CDRS-R at 10 weeks. No new duloxetine safety signals were identified relative to those seen in adults. Clinical Trial Registry Number: NCT00849901 © Mary Ann Liebert, Inc.

Language: en

Keywords

Humans; adolescent; Child; Female; Male; human; Adolescent; Severity of Illness Index; suicide; Suicide; child; female; male; Psychiatric Status Rating Scales; Treatment Outcome; Suicidal Ideation; Double-Blind Method; suicidal ideation; randomized controlled trial; major depression; conversion disorder; clinical trial; Antidepressive Agents; treatment outcome; drug overdose; Dose-Response Relationship, Drug; epilepsy; article; comparative study; major clinical study; controlled study; antidepressant agent; fluoxetine; pathophysiology; serotonin uptake inhibitor; automutilation; double blind procedure; phase 3 clinical trial; childhood disease; psychopharmacotherapy; convulsion; drug safety; placebo; long term care; drug efficacy; nausea; social phobia; drug withdrawal; restlessness; side effect; hypomania; duloxetine; alanine aminotransferase; dose response; adjustment disorder; adolescent disease; low drug dose; Serotonin Uptake Inhibitors; electrocardiography; Fluoxetine; psychological rating scale; pneumonia; Depressive Disorder, Major; systolic blood pressure; gastritis; drug induced headache; drug dose increase; drug dose titration; Thiophenes; alanine aminotransferase blood level; vital sign; thiophene derivative; diastolic blood pressure; rhinopharyngitis; abnormal laboratory result; drug dose escalation; compression fracture; faintness; severity of illness index; columbia suicide severity rating scale; children depression rating scale; lymphadenitis; pilonidal sinus; ulna fracture