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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

151 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-29

Study Completion Date

2020-07-04

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

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

NCT03315793

Depressive Disorder

COMPLETED PHASE3

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

NCT00849693

Major Depressive Disorder

COMPLETED PHASE3

A Study in the Treatment of Children and Adolescents With Major Depressive Disorder

NCT00849901

Major Depressive Disorder

COMPLETED PHASE3

Subject Information and Consent Form F1J-US-HMCB Duloxetine Once-Daily Dosing Versus Placebo in Patients With Major Depression and Pain

NCT00036335

Depression Pain

COMPLETED PHASE3

Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder

NCT00529789

Major Depressive Disorder

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depressive Disorder

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Duloxetine hydrochloride

Duloxetine hydrochloride administered orally.

Group Type EXPERIMENTAL

Duloxetine Hydrochloride

Intervention Type DRUG

Administered orally

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Duloxetine Hydrochloride

Administered orally

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

LY248686

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

9 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No