Fluoxetine 40-60 mg versus fluoxetine 20 mg in the treatment of children and adolescents with a less-than-complete response to nine-week treatment with fluoxetine 10-20 mg: a pilot study.
OBJECTIVE
The aim of this study was to compare fluoxetine dosage titration to 40-60 mg/day with fixed fluoxetine 20-mg/day treatment for an additional 10 weeks in pediatric outpatients with major depressive disorder (MDD) who had not met protocol-defined response criteria after 9-week acute fluoxetine treatment.


METHODS
Patients unresponsive (less than or equal to 30% decrease in Children's Depression Rating Scale-Revised [CDRS-R] score) after 9-week fluoxetine treatment were randomly reassigned to continue at 20 mg/day or to increase to 40 mg/day. After 4 weeks, patients unresponsive to 40 mg/day could receive 60 mg/day.


RESULTS
Twenty-nine (29) patients, 9-17 years of age, received fluoxetine 40-60 mg/day (n = 14) or 20 mg/day (n = 15). At the conclusion of this study phase, 10 patients (71%) on 40-60 mg/day met the response criteria, versus 5 patients (36%) on 20 mg/day (p = 0.128). Mean CDRS-R scores improved in both treatment groups (fluoxetine 40-60 mg/day, -9.4; fluoxetine 20 mg/day, -1.5; p = 0.099). Adverse events were similar in both groups. However, this study phase was statistically underpowered for detecting differences between treatment groups.


CONCLUSIONS
More than two thirds of patients whose dosage was increased responded within 10 weeks, suggesting dose escalation may benefit some patients. Approximately one third of patients unresponsive to initial treatment with fluoxetine 20 mg responded to this fixed dosage within another 10 weeks. Fluoxetine 20-60 mg/day was well tolerated.
Lilly Research Laboratories, Eli Lilly and Company, Indianapolis, Indiana 46285, USA. jheiligenstein@comcast.net
John H
JH
Heiligenstein
Sharon L
SL
Hoog
Karen Dineen
KD
Wagner
Robert L
RL
Findling
Nora
N
Galil
Stuart
S
Kaplan
Joan
J
Busner
Mary E
ME
Nilsson
Eileen B
EB
Brown
Jennie G
JG
Jacobson
D000293:Adolescent; D018687:Antidepressive Agents, Second-Generation / Q000008:administration & dosage* / Q000009:adverse effects; D002648:Child; D003865:Major Depressive Disorder / Q000188:drug therapy* / Q000453:epidemiology* / Q000523:psychology; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005473:Fluoxetine / Q000008:administration & dosage* / Q000009:adverse effects; D006801:Humans; D008297:Male; D010554:Personality Disorders / Q000139:chemically induced / Q000453:epidemiology; D010865:Pilot Projects; D013997:Time Factors
D018687:Antidepressive Agents, Second-Generation; D005473:Fluoxetine