Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder - Full Text View

Sponsored by:	Eli Lilly and Company
Information provided by:	Eli Lilly and Company
ClinicalTrials.gov Identifier:	NCT00529789

Purpose

The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.

Condition	Intervention	Phase
Major Depressive Disorder	Drug: duloxetine	Phase II

MedlinePlus related topics: Depression

Drug Information available for: Duloxetine Duloxetine hydrochloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Dose Comparison, Single Group Assignment, Pharmacokinetics Study
Official Title:	F1J-MC-HMFN (a) An Open-Label Study of Tolerability, Safety, and Pharmacokinetics of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:

Item 13 of the Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Columbia-Suicide Severity Rating Scale (C-SSRS) [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Vital signs [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Laboratory analytes [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Electrocardiograms [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Spontaneously reported adverse events [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Pharmacokinetics [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]
Clinical Global Impressions of Severity Scale (CGI-S) [ Time Frame: over 30 weeks ] [ Designated as safety issue: No ]
Children's Depression Rating Scale-Revised (CDRS-R) [ Time Frame: over 30 weeks ] [ Designated as safety issue: Yes ]

Enrollment:	72
Study Start Date:	August 2007
Study Completion Date:	September 2008
Primary Completion Date:	September 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Weight greater than 40 kg	Drug: duloxetine 20 - 120 mg QD, PO for 30 weeks; If patient is <40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.
B: Experimental Weight 20-40 kg	Drug: duloxetine 20 - 120 mg QD, PO for 30 weeks; If patient is <40kg, initial dose is 20mg, then titrated up. If patient is >40kg, initial dose is 30mg, then titrated up.

Eligibility

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

Criteria

Inclusion Criteria:

Male / Female outpatients 7 to 17 years of age diagnosed with MDD. (Must have a CDRS-R with a total score greater than 40 at Visit 1, Visit 2, and Visit 3 and a CGI-Severity rating of greater than 4 at Visit 1, Visit 2, and Visit 3.)
Female patients must test negative on a pregnancy at visit 1.

Exclusion Criteria:

Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or ECG result, hypersensitivity to duloxetine, or to its inactive ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C)that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
Have a significant suicide attempt within 1 year of Visit 1 or have a score of 5 or greater on Item 13 (Suicidal Ideation) on the CDRS-R at Visit 1, Visit 2, or Visit 3, or are currently at risk of suicide in the opinion of the investigator.
Have a weight less than 20 kg at any Screening Phase visit.
Have previous exposure to duloxetine
Female patients who are either pregnant, nursing or have recently given birth.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00529789

Show 22 Study Locations

Sponsors and Collaborators

Eli Lilly and Company

Investigators

Study Director:

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9AM-5PM Eastern Standard time (UTC/GMT - 5 hours, EST)

Eli Lilly and Company

More Information

Lilly Clinical Trial Registry This link exits the ClinicalTrials.gov site

Responsible Party:	Eli Lilly ( Chief Medical Officer )
Study ID Numbers:	11664, F1J-MC-HMFN
Study First Received:	September 12, 2007
Last Updated:	November 19, 2008
ClinicalTrials.gov Identifier:	NCT00529789
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Dopamine
Depression
Mental Disorders
Mood Disorders
Depressive Disorder, Major

Depressive Disorder
Serotonin
Duloxetine
Behavioral Symptoms

Additional relevant MeSH terms:

Dopamine Uptake Inhibitors
Neurotransmitter Uptake Inhibitors
Neurotransmitter Agents
Disease
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs

Serotonin Uptake Inhibitors
Pharmacologic Actions
Pathologic Processes
Serotonin Agents
Therapeutic Uses
Dopamine Agents
Central Nervous System Agents
Antidepressive Agents

ClinicalTrials.gov processed this record on January 15, 2009