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

Shionogi

Status and phase: Completed; Phase 3

Conditions: Depressive Disorder

Treatments: Drug: Duloxetine Hydrochloride; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT03315793

F1J-JE-B058 (Other Identifier)

14937

1701A3631 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to determine the efficacy of duloxetine hydrochloride versus placebo in the treatment of Japanese children and adolescents with depressive disorder.

Enrollment: 149 patients

Sex: All

Ages: 9 to 17 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.
• Participants whose incipient age of depression was ≥7 years old.
• Total score of CDRS-R is ≥40 and CGI-S score is ≥4 at both screening and baseline.

Exclusion criteria

• Have remarkable response to psycho-education (defined as >30% decrease in the total score of CDRS-R between screening and baseline).

• 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

• 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

• Have personality disorders, in the judgement of the investigator.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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149 participants in 2 patient groups, including a placebo group

Duloxetine Hydrochloride

Experimental group

Description:

Duloxetine hydrochloride given orally.

Treatment:

Drug: Duloxetine Hydrochloride

Placebo

Placebo Comparator group

Description:

Placebo given orally.

Treatment:

Drug: Placebo