A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder

Graham J. Emslie, Apurva Prakash, Qi Zhang, Beth A. Pangallo, Mark E. Bangs, John S. March

Research output: Contribution to journalArticle

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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.

Original languageEnglish (US)
Pages (from-to)170-179
Number of pages10
JournalJournal of Child and Adolescent Psychopharmacology
Volume24
Issue number4
DOIs
StatePublished - May 1 2014

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Major Depressive Disorder
Safety
Fluoxetine
Placebos
Suicidal Ideation
Therapeutics
Depression
Suicide
Duloxetine Hydrochloride
Investigational Drugs
Electrocardiography

ASJC Scopus subject areas

  • Pharmacology (medical)
  • Pediatrics, Perinatology, and Child Health
  • Psychiatry and Mental health
  • Medicine(all)

Cite this

A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. / Emslie, Graham J.; Prakash, Apurva; Zhang, Qi; Pangallo, Beth A.; Bangs, Mark E.; March, John S.

In: Journal of Child and Adolescent Psychopharmacology, Vol. 24, No. 4, 01.05.2014, p. 170-179.

Research output: Contribution to journalArticle

Emslie, Graham J. ; Prakash, Apurva ; Zhang, Qi ; Pangallo, Beth A. ; Bangs, Mark E. ; March, John S. / A double-blind efficacy and safety study of duloxetine fixed doses in children and adolescents with major depressive disorder. In: Journal of Child and Adolescent Psychopharmacology. 2014 ; Vol. 24, No. 4. pp. 170-179.
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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.",
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AU - Bangs, Mark E.

AU - March, John S.

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N2 - 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.

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