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| ID | Type | Description | Link |
|---|---|---|---|
| F1J-JE-B058 | Other Identifier | Eli Lilly and Company | |
| 1701A3631 | Other Identifier | Shionogi |
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| Name | Class |
|---|---|
| Eli Lilly and Company | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Duloxetine Hydrochloride | Experimental | Duloxetine hydrochloride given orally. |
|
| Placebo | Placebo Comparator | Placebo given orally. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine Hydrochloride | Drug | Administered orally |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score | 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. | Baseline, Week 6 |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline | 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. |
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Inclusion Criteria:
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:
Have a current diagnosis (DSM-5) of the following as judged by the investigator:
Have personality disorders, in the judgement of the investigator.
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| Name | Affiliation | Role |
|---|---|---|
| Shionogi Clinical Trial Administrator Clinical Support Help Line | Shionogi | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shionogi | Osaka | 541-0045 | Japan |
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| ID | Title | Description |
|---|---|---|
| FG000 | Duloxetine | 20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period. |
| FG001 | Placebo | Placebo was administered every day for 7 weeks. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
All randomized participants who received at least one dose of drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis.
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| ID | Title | Description |
|---|---|---|
| BG000 | Duloxetine | 20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses Duloxetine were administered for 1 week during tapering off period. |
| BG001 | Placebo |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score | 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. | All randomized participants who received 1 dose of study drug and had 1 post-baseline CDRS-S score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 6 |
Baseline to 7 Weeks
All participants who received at least one dose of study drug. Gender specific events occurring only in male or female participants have had the number of participants At Risk adjusted accordingly.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Duloxetine | 20 mg Duloxetine was administered for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Anaemia | Blood and lymphatic system disorders | MedDRA 20.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Shionogi Clinical Trial Administrator | Shionogi | +81-6-6209-7885 | shionogiclinicaltrials-admin@shionogi.co.jp |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 8, 2018 | Oct 23, 2020 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 17, 2020 | Oct 23, 2020 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D003866 | Depressive Disorder |
| ID | Term |
|---|---|
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | Administered orally |
|
| Baseline, Week 6 |
| Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline | 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. | Baseline, Week 6 |
| Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28 | 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. | Baseline, Week 6 |
| Change From Baseline on Clinical Global Impression-Severity (CGI-S) | 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. | Baseline, Week 6 |
| Difficult for regular visit |
|
Placebo was administered every day for 7 weeks. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants | No |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants | No |
|
| Region of Enrollment | Count of Participants | Participants | No |
|
| Children's Depression Rating Scale-Revised (CDRS-R) Total Score | 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 higher 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. | Mean | Standard Deviation | units on a scale |
|
| ID | Title | Description |
|---|---|---|
| OG000 | Duloxetine | 20 mg Duloxetine was administered every day for 1 week. Then 40 mg Duloxetine was administered for 1 week. Then flexible doses of 40 mg or 60 mg Duloxetine were administered for 4 weeks. Lower doses of Duloxetine were administered for 1 week during tapering off period. |
| OG001 | Placebo | Placebo was administered every day for 7 weeks. |
|
|
|
| Secondary | Percentage of Participants Whose Children's Depression Rating Scale-Revised (CDRS-R) Total Score Decreased by More Than 30% From Baseline | 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. | All randomized participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used. | Posted | Number | percentage of participants | Baseline, Week 6 |
|
|
|
|
| Secondary | Percentage of Participants Whose CDRS-R Total Score Decreased by More Than 50% From Baseline | 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. | All randomized participants who received at least one dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used. | Posted | Number | percentage of participants | Baseline, Week 6 |
|
|
|
|
| Secondary | Percentage of Participants With Total Children's Depression Rating Scale-Revised (CDRS-R) Score ≤ 28 | 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. | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose CDRS-R Total Score. One participant in the duloxetine group had no post-dose CDRS-R Total Score and was not included in the analysis. The last observation carried forward (LOCF) method was used. | Posted | Number | percentage of participants | Baseline, Week 6 |
|
|
|
|
| Secondary | Change From Baseline on Clinical Global Impression-Severity (CGI-S) | 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. | All randomized participants who received at least 1 dose of study drug and had at least 1 post-dose CDRS-R Total score. One duloxetine participant had no post-dose CDRS-R Total Score and was not included in the analysis. | Posted | Least Squares Mean | Standard Error | units on a scale | Baseline, Week 6 |
|
|
|
|
| 0 |
| 75 |
| 0 |
| 75 |
| 59 |
| 75 |
| EG001 | Placebo | Placebo was administered every day for 7 weeks. | 0 | 74 | 0 | 74 | 46 | 74 |
| Palpitations | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sinus arrhythmia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tachycardia | Cardiac disorders | MedDRA 20.1 | Systematic Assessment |
|
| Tinnitus | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 20.1 | Systematic Assessment |
|
| Conjunctivitis allergic | Eye disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dental caries | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Lip dry | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Fatigue | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Feeling abnormal | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Feeling hot | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Malaise | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Thirst | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Vaccination site swelling | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Withdrawal syndrome | General disorders | MedDRA 20.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Laryngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Otitis externa | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA 20.1 | Systematic Assessment |
|
| Chillblains | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Wound | Injury, poisoning and procedural complications | MedDRA 20.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Aspartate aminotransferase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood bilirubin increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood creatine phosphokinase increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure decreased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood pressure increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Heart rate increased | Investigations | MedDRA 20.1 | Systematic Assessment |
|
| Decreased appetite | Metabolism and nutrition disorders | MedDRA 20.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Akathisia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dizziness postural | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Head discomfort | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Presyncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Syncope | Nervous system disorders | MedDRA 20.1 | Systematic Assessment |
|
| Aggression | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Agitation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Euphoric mood | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Initial insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Intentional self-injury | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Irritability | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Nightmare | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Sleep disorder | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Suicidal ideation | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
|
| Suicide attempt | Psychiatric disorders | MedDRA 20.1 | Systematic Assessment |
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| Urinary retention | Renal and urinary disorders | MedDRA 20.1 | Systematic Assessment |
|
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Menstruation irregular | Reproductive system and breast disorders | MedDRA 20.1 | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Oropharyngeal discomfort | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Rhinorrhoea | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Yawning | Respiratory, thoracic and mediastinal disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis atopic | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Eczema | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Urticaria thermal | Skin and subcutaneous tissue disorders | MedDRA 20.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
| Orthostatic hypotension | Vascular disorders | MedDRA 20.1 | Systematic Assessment |
|
Not provided
| D006571 |
| Heterocyclic Compounds |