Monday, October 11, 2010

Eli-Lilly studies SSRIs Cymbalta and Prozac in children 7-17 years old

I have already reported it here and the recruitment of children is still going on and will end in December 2011:
A Study in the Treatment of Children and Adolescents With Major Depressive Disorder
This study is currently recruiting participants.
Verified by Eli Lilly and Company, July 2010
First Received: February 23, 2009 Last Updated: July 27, 2010 History of Changes
Sponsor:Eli Lilly and Company
Information provided by:Eli Lilly and Company
ClinicalTrials.gov Identifier:NCT00849693

The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Major Depressive Disorder
Drug: Placebo
Drug: fluoxetine
Drug: duloxetine
Phase III

Study Type:Interventional
Study Design:Allocation: Randomized
Control: Placebo Control
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title:A Double-Blind, Efficacy and Safety Study of Duloxetine Versus Placebo in the Treatment of Children and Adolescents With Major Depressive Disorder


Ages Eligible for Study: 7 Years to 17 Years
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Read more at clinicaltrialsOrg.

Prescribing SSRIs for children is not approved:

"Children (18 years or younger) taking antidepressants experience suicidal thoughts or actions in about 1 out of every 50 who are depressed. Although duloxetine is prescribed for children, the FDA has not approved duloxetine for use in children."
Source: Nami

Still this study is being done since last year. After reading the post below it seems that neither Japanese or American children are respected and when profit is being done at the expenses of the health and life of children it is hard to understand what is integrity and ethics in medicine.


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