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A Clinical Study With Children and Adolescents With Major Depressive Disorder
This study is currently recruiting participants.
Verified by Clinical Innovations, May 2009
First Received: May 1, 2009   No Changes Posted
Sponsored by: Clinical Innovations
Information provided by: Clinical Innovations
ClinicalTrials.gov Identifier: NCT00892294
  Purpose

The investigators are conducting a clinical study for children and adolescents with Major Depressive Disorder.


Condition Intervention Phase
Major Depressive Disorder
Drug: Duloxetine
Drug: Fluoxetine
Drug: Placebo
Phase III

MedlinePlus related topics: Depression
Drug Information available for: Fluoxetine Fluoxetine hydrochloride Duloxetine Duloxetine hydrochloride
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Single Group Assignment, Safety/Efficacy Study
Official Title: Clinical Study With Children and Adolescents With Major Depressive Disorder

Further study details as provided by Clinical Innovations:

Primary Outcome Measures:
  • Test effects of duloxetine [ Time Frame: 38 Weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 392
Study Start Date: September 2008
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Duloxetine: Experimental
Duloxetine
Drug: Duloxetine
Duloxetine
Fluoxetine: Experimental
Fluoxetine
Drug: Fluoxetine
Fluoxetine
Placebo: Experimental
Placebo
Drug: Placebo
Placebo

Detailed Description:

A Double-Blind, Efficacy adn Safety Study of Duloxetine versus Placebo in the Treatment of Children and Adolescents with Major Depressive Disorder.

  Eligibility

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

Inclusion Criteria:

Must be 7-17 years of age Have a diagnosis of MDD Have parental consent

Exclusion Criteria:

  • Have received treatment within the last 30 days with a drug that has not received regulatory approval for any indication at the time of the study entry.
  • Have a current diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, or pervasive development disorder.
  • Have history of DSM-IV-TR defined substance abuse or dependence within the past year, excluding caffeine and nicotine.
  • Have a current DSM-IV-TR defined disorder other than MDD.
  • Have 1 or more first-degree relatives with diagnosed bipolar I disorder.
  • Have a significant suicide attempt within 1 year of Visit 1 or currently at risk.-
  • Have weight of less than 44 pounds.
  • Have initiated, stopped or changed the type or intensity of psychotherapy with 6 weeks.
  • Have history of seizure disorder.
  • Have a history of electroconvulsive therapy with 1 year of visit 1.
  • Have had treatment of monoamine oxidase inhibitor (MAOI) with 14 days or fluoxetine with 30 day of visit 3.
  • Have been recently enrolled in a study of or fluoxetine.
  • Have a positive urine drug screen.
  • Have know hypersensitivity to duloxetine, fluoxetine, or their inactive ingredients.
  • Are taking any excluded medications.
  • Have uncontrolled narrow-angle glaucoma.
Have acute liver injury or severe cirrhosis.
Have serious or unstable mental illness.
Have abnormal thyroid-stimulating hormone (TSH)
Have initiated or discontinued hormone therapy within the previous 3 months.
Female patients that are pregnant.
Need to use thioridazine.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00892294

Contacts
Contact: David Cohen (866) 478-8391 volunteers@citrials.com

Locations
United States, California
Clinical Innovations Recruiting
Riverside, California, United States
Contact: David Cohen     866-478-8391     volunteers@citrials.com    
Sponsors and Collaborators
Clinical Innovations
  More Information

Additional Information:
No publications provided

Responsible Party: Clinical Innovations ( David Poling )
Study ID Numbers: F1J-MC-HMCL
Study First Received: May 1, 2009
Last Updated: May 1, 2009
ClinicalTrials.gov Identifier: NCT00892294     History of Changes
Health Authority: United States: Institutional Review Board

Keywords provided by Clinical Innovations:
Major Depressive Disorder, depression

Study placed in the following topic categories:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Depression
Adrenergic Agents
Psychotropic Drugs
Depressive Disorder, Major
Depressive Disorder
Serotonin Uptake Inhibitors
Duloxetine
Serotonin
Behavioral Symptoms
Fluoxetine
Dopamine
Mental Disorders
Mood Disorders
Dopamine Agents
Antidepressive Agents, Second-Generation
Antidepressive Agents

Additional relevant MeSH terms:
Dopamine Uptake Inhibitors
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Adrenergic Agents
Adrenergic Uptake Inhibitors
Physiological Effects of Drugs
Psychotropic Drugs
Depressive Disorder, Major
Duloxetine
Pathologic Processes
Mental Disorders
Therapeutic Uses
Antidepressive Agents, Second-Generation
Antidepressive Agents
Disease
Depression
Depressive Disorder
Serotonin Uptake Inhibitors
Pharmacologic Actions
Behavioral Symptoms
Fluoxetine
Serotonin Agents
Mood Disorders
Dopamine Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 07, 2009