Phase 2
Completed N=72
Open-Label Study of Duloxetine in the Treatment of Children and Adolescents With Major Depressive Disorder
Source: ClinicalTrials.gov NCT00529789 ↗Enrolled (actual)
72
Serious AEs
4.2%
Results posted
Dec 2009
Primary outcomePrimary: Number of Participants With Emergence of Suicidal Ideation During Period II/III — 2 participants
Summary
The primary purpose of your participation in this study is to help answer the following research question, and not to provide you treatment for your condition. Whether duloxetine once daily orally is tolerated and safe, in children (aged 7 through 11 years) and adolescents (aged 12 through 17 years) with Major Depressive Disorder.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Emergence of Suicidal Ideation During Period II/III |
2 | — |
| PRIMARY Number of Participants With Emergence of Suicidal Ideation During Period IV |
— | — |
| PRIMARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period II/III |
0; 1; 1 | — |
| PRIMARY Number of Participants Experiencing Suicidal Ideation or Suicidal Behavior Based on Columbia-Suicide Severity Rating Scale (C-SSRS) During Period IV |
0; 0; 1 | — |
| PRIMARY Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period II/III |
22; 25; 2 | — |
| PRIMARY Number of Participants Meeting Criteria for Potentially Clinically Significant Vital Sign Values at Any Time During Period IV |
3; 1; 0 | — |
| PRIMARY Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period II/III |
1; 6; 1; 8; 1; 16 | — |
| PRIMARY Number of Participants Meeting Criteria for Potentially Clinically Significant (PCS) Laboratory Analyte Values at Any Time During Period IV |
1; 1; 3 | — |
| PRIMARY Number of Participants Meeting Criteria for Potentially Clinically Significant Electrocardiograms at Any Time in Period II/III |
1; 2; 0 | — |
| PRIMARY Number of Participants With Potentially Clinically Significant Electrocardiograms at Any Time in Period IV |
1; 1; 0 | — |
| SECONDARY Pharmacokinetics: Summary of Observed Duloxetine Plasma Concentrations Stratified by Duloxetine Dose |
15.2; 20.8; 41.1; 57.6; 77.6 | — |
| SECONDARY Change From Baseline to 18 Weeks and 30 Weeks in Clinical Global Impressions of Severity Scale (CGI-S) |
4.5; -2.11; 4.5; -2.7 | — |
| SECONDARY Change From Baseline to 18 Weeks and 30 Weeks in Children's Depression Rating Scale-Revised (CDRS-R) Total Score |
61.69; -32.11; 61.8; -38.8 | — |
Eligibility Criteria
Inclusion Criteria
- Male / Female outpatients 7 to 17 years of age diagnosed with Major Depressive Disorder (MDD). (Must have a Children's Depression Rating Scale-Revised [CDRS-R] with a total score greater than or equal to 40 at Visit 1, Visit 2, and Visit 3 and a Clinical Global Impressions of Severity [CGI-Severity] rating of greater than or equal to 4 at Visit 1, Visit 2, and Visit 3.)
- Female patients must test negative on a pregnancy at visit 1.
Exclusion Criteria
- Have a serious or unstable medical illness, psychological condition, clinically significant laboratory or electrocardiogram (ECG) result, hypersensitivity to duloxetine, or to its inactive ingredients, frequent or severe allergic reactions to multiple medications, uncontrolled narrow-angle glaucoma, acute liver injury (for example, hepatitis) or severe cirrhosis (Child-Pugh Class C) that in the opinion of the investigator would compromise participation in the study or be likely to lead to hospitalization during the course of the study.
- Have a current or previous diagnosis of bipolar disorder, psychotic depression, schizophrenia or other psychotic disorder, anorexia, bulimia, obsessive compulsive disorder, pervasive development disorder or borderline personality disorder, as determined by the investigator.
- Have a significant suicide attempt within 1 year of Visit 1 or have a score of 5 or greater on Item 13 (Suicidal Ideation) on the CDRS-R at Visit 1, Visit 2, or Visit 3, or are currently at risk of suicide in the opinion of the investigator.
- Have a weight less than 20 kg at any Screening Phase visit.
- Have previous exposure to duloxetine
- Female patients who are either pregnant, nursing or have recently given birth.
Data sourced from ClinicalTrials.gov (NCT00529789). 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.