Clinical trial NCT03315793: A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Official title: A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Depressive Disorder
Lead sponsor: Shionogi Inc.
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2017-10-20
Enrollment: 149
Sex: ALL
Minimum age (years): 9
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score
timeFrame: Baseline, Week 6
Secondary outcomes:
measure: Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline
timeFrame: Baseline, Week 6
measure: Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline
timeFrame: Baseline, Week 6
measure: Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28
timeFrame: Baseline, Week 6
measure: Change From Baseline on Clinical Global Impression-Severity (CGI-S)
timeFrame: Baseline, Week 6
Other outcomes:
Locations:
city: Osaka
country: Japan
facility: Shionogi
Study officials:
affiliation: Shionogi
name: Shionogi Clinical Trial Administrator Clinical Support Help Line
role: STUDY_DIRECTOR
References: