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Completed

NCT Number: NCT03315793

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

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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Key information

Conditions

Depressive Disorder Mental Disorders Mood Disorders

Age range

9 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Shionogi

Osaka, 541-0045, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

duloxetine hydrochloride

Drug

Administered orally

Other names: LY248686

Placebo

Drug

Administered orally

Primary outcomes

  1. Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score

    Time frame: Baseline, Week 6

    Change from baseline on the Children's Depression Rating Scale-Revised (CDRS-R) total score. CDRS-R Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and a higher number indicates a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Least squares (LS) mean was calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CDRS-R total score and age as covariates.

Secondary outcomes

  1. Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline

    Time frame: Baseline, Week 6

    The Children's Depression Rating Scale-Revised (CDRS-R) Total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.

  2. Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline

    Time frame: Baseline, Week 6

    The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning with higher numbers indicating a greater degree of depression . The total sum of scores range from 17 to 113. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression.

  3. Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28

    Time frame: Baseline, Week 6

    The Children's Depression Rating Scale-Revised (CDRS-R) total score measures the presence and severity of depression in children. The scale consists of 17 items scored on a 1-to-5- or 1-to-7-point scale. A rating of 1 indicates normal functioning and higher numbers indicate a greater degree of depression. The total sum of scores range from 17 to 113. In general, scores below 20 indicate an absence of depression, scores of 20 to 30 indicate borderline depression, scores of 40 to 60 indicate moderate depression, and scores greater than 60 indicate severe depression. Remission was defined for the CDRS-R total score below 28.

  4. Change From Baseline on Clinical Global Impression-Severity (CGI-S)

    Time frame: Baseline, Week 6

    CGI-S measures severity of illness at the time of assessment compared with start of treatment. Scores range from 1 (normal, not at all ill) to 7 (among the most extremely ill patients). Presented here are the LS mean change from baseline on CGI-S calculated using a mixed-effects model repeated measures (MMRM) approach including treatment group, observation time-points, and interaction between treatment group and observation time-points as fixed effects, and baseline CGI-S and age as covariates.

Sponsors and collaborators

Lead sponsor

Shionogi

Industry

Collaborators

  • Eli Lilly and Company

Registry information

Official study title

A Double-blind, Efficacy and Safety Study of Duloxetine Hydrochloride Versus Placebo in the Treatment of Japanese Children and Adolescents With Depressive Disorder

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Oct 20, 2017
Registry last updated
Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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