Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Condition: Major Depressive Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major
Intervention: duloxetine
Intervention description: 20 - 120 milligrams (mg) every day, once-daily (QD), by mouth (PO) for 30 weeks; If patient is ≤40 kilograms (kg), initial dose is 20 mg, then titrated up. If patient is >40 kg, initial dose is 30 mg, then titrated up.
Intervention MeSH terms: Duloxetine Hydrochloride
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 72.0
Sex: All
Minimum age: 7 Years
Maximum age: 17 Years
Healthy volunteers: No

Summary:

      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.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male / Female outpatients 7 to 17 years of age diagnosed with Major Depressive
             Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised [CDRS-R] with
             a total score greater than or equal to 40 at Visit 1, Visit 2, and Visit 3 and a
             Clinical Global Impressions of Severity [CGI-Severity] rating of greater than or equal
             to 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 electrocardiogram (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.