Phase 3
Completed N=149
A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
Source: ClinicalTrials.gov NCT03315793 ↗Enrolled (actual)
149
Serious AEs
0.0%
Results posted
Jan 2021
Primary outcomePrimary: Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score — -21.03; -22.42 units on a scale — p=0.5587
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score |
-21.03; -22.42 | 0.5587 |
| SECONDARY Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline |
48.6; 43.2 | 0.5111 |
| SECONDARY Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline |
21.6; 21.6 | 1.0000 |
| SECONDARY Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28 |
9.5; 13.5 | 0.4423 |
| SECONDARY Change From Baseline on Clinical Global Impression-Severity (CGI-S) |
-1.24; -1.38 | 0.3836 |
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.
Data sourced from ClinicalTrials.gov (NCT03315793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.