justAna: Eli-Lilly recruits children aged 7- 17 years old for Cymbalta and Prozac clinical trial (repost)

Monday, March 15, 2010

Eli-Lilly recruits children aged 7- 17 years old for Cymbalta and Prozac clinical trial (repost)

They are still recruiting and when I first published I forgot to stress that Prozac is also part of the clinical trial.

It is Cymbalta (duloxetine) and Prozac (fluoxetine).

"You can read here the government recruiting children aged 7 to 17 years old. No healthy volunteers accepted this time. If anything happens they can blame it on the disease because although the UK Parliament has already recognized drug-induced suicidal ideation nothing was done. Two of the exclusion criteria for this clinical trial:

Children of site personnel directly affiliated with this study and/or their immediate families.

Children of Lilly employees or employees of the designated CRO assisting with the conduct of the study.

At least they care about the life of their own children and the children of their employees.
Extracts from the government page:

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, September 2009

First Received: February 23, 2009 Last Updated: September 14, 2009 History of Changes

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00849693

Purpose

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)

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

_______________________________________________________________

Estimated Enrollment:	448
Study Start Date:	March 2009
Estimated Study Completion Date:	March 2012
Estimated Primary Completion Date:	March 2012 (Final data collection date for primary outcome measure)

Eligibility

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

Criteria

Inclusion Criteria:

Outpatient, diagnosed with MDD as defined by the DSM-IV-TR and supported by the MINI-KID.
Diagnosis of moderate or greater severity of MDD as determined by CDRS-R with a total score greater than or equal to 40 at screen, and randomization and a CGI-Severity rating of greater than or equal to 4 at screen, and randomization.
Female patients must test negative for pregnancy during screening.
Judged to be reliable by the investigator to keep all appointments for clinical visits, tests, and procedures required by the protocol.
Has a degree of understanding such that they can communicate intelligently with the investigator and study coordinator.
Capable of swallowing study drug whole. It is anticipated the patients will need to swallow up to 6 capsules per day.
Patients must have venous access sufficient to allow blood sampling and are compliant with blood draws as per the protocol.

Exclusion Criteria:

Children of site personnel directly affiliated with this study and/or their immediate families.
Children of Lilly employees or employees of the designated CRO assisting with the conduct of the study.

__________________________________________________________

ClinicalTrials.gov processed this record on October 20, 2009