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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

149 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-04

Study Completion Date

2019-11-08

Brief Summary

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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.

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Detailed Description

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Conditions

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Depressive Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Duloxetine Hydrochloride

Duloxetine hydrochloride given orally.

Group Type EXPERIMENTAL

Duloxetine Hydrochloride

Intervention Type DRUG

Administered orally

Placebo

Placebo given orally.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Administered orally

Interventions

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Duloxetine Hydrochloride

Administered orally

Intervention Type DRUG

Placebo

Administered orally

Intervention Type DRUG

Other Intervention Names

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LY248686

Eligibility Criteria

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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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No