Citation

Emslie GJ, Prakash A, Zhang Q, Pangallo BA, Bangs ME, March JS. J. Child Adolesc. Psychopharmacol. 2014; 24(4): 170-179.

Copyright

(Copyright © 2014, Mary Ann Liebert Publishers)

DOI

10.1089/cap.2013.0096

PMID

unavailable

Abstract

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

METHODS: Patients (n=463) in this 36 week study (10 week acute and 26 week extension treatment) received duloxetine 60mg QD (n=108), duloxetine 30mg QD (n=116), fluoxetine 20mg QD (n=117, active control), or placebo (n=122). 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. Total TEAEs and discontinuation for AEs were significantly (p<0.05) higher only for the duloxetine 60mg group versus the placebo group during acute treatment. No clinically significant electrocardiogram (ECG) or laboratory abnormalities were observed, and no completed suicides or deaths occurred during the study. A total of 7 (6.7%) duloxetine 60mg, 6 (5.2%) duloxetine 30mg, 9 (8.0%) fluoxetine, and 11 (9.4%) placebo patients had worsening of suicidal ideation from baseline during acute treatment. Of the patients with suicidal ideation at baseline, 13/16 (81%) duloxetine 60mg, 16/17 (94%) duloxetine 30mg, 11/16 (69%) fluoxetine, and 13/15 (87%) placebo had improvement in suicidal ideation at end-point during acute treatment. One fluoxetine, one placebo, and six duloxetine patients had treatment-emergent suicidal behavior during the 36 week study.

CONCLUSIONS: 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.

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; depression; aggression; randomized controlled trial; suicide attempt; major depression; suicidal behavior; clinical trial; Antidepressive Agents; risk assessment; treatment outcome; Dose-Response Relationship, Drug; fatigue; article; comparative study; major clinical study; vomiting; controlled study; antidepressant agent; rating scale; child psychiatry; fluoxetine; pathophysiology; serotonin uptake inhibitor; automutilation; double blind procedure; hallucination; phase 3 clinical trial; somnolence; childhood disease; drug safety; placebo; long term care; drug efficacy; drug tolerability; nausea; drug withdrawal; side effect; duloxetine; dose response; adolescent disease; low drug dose; Serotonin Uptake Inhibitors; Fluoxetine; psychological rating scale; body mass; drug dose reduction; Depressive Disorder, Major; systolic blood pressure; drug induced headache; outcome assessment; Thiophenes; treatment duration; Clinical Global Impression scale; thiophene derivative; diastolic blood pressure; drug dose comparison; placebo effect; drug dose escalation; upper abdominal pain; children depression rating scale revised; severity of illness index; DSM-IV-TR; phase 3 clinical trial (topic); columbia suicide severity rating scale; elevated blood pressure