A Study of Duloxetine (LY248686) in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Shionogi

Status and phase: Terminated; Phase 3

Conditions: Depressive Disorder

Treatments: Drug: Duloxetine Hydrochloride

Study type: Interventional

Funder types: Industry

Identifiers

NCT03395353

16916

1702A3632 (Other Identifier)

F1J-JE-HMHF (Other Identifier)

Details and patient eligibility

About

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.

Enrollment: 151 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

• a) Participants extended from B058(1701A3631) study.
• b) New participants.

Inclusion Criteria

• a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
• b) Participants diagnosed with Major Depressive Disorder or persistent depressive disorder and completely meet the criteria of major depressive episode as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID) ver.7.0.2.
• b) Participants whose incipient age of depression was ≥7 years old.

Exclusion Criteria:

• a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:

  • Neurodevelopmental disorders
  • Schizophrenia spectrum and other psychotic disorders
  • Bipolar and related disorders
  • Trauma and stressor-related disorders
  • Disruptive · Impulse Control · and Conduct disorders

• a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:

  • Obsessive-compulsive and related disorders
  • Anorexia nervosa, Bulimia nervosa, Binge-eating disorder
  • Sleep-wake disorders
  • Neurocognitive disorders
  • Disruptive mood dysregulation disorder

• a, b) Have personality disorders, in the judgment of the investigator.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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151 participants in 1 patient group

Duloxetine hydrochloride

Experimental group

Description:

Duloxetine hydrochloride administered orally.

Treatment:

Drug: Duloxetine Hydrochloride