A Study of Duloxetine (LY248686) in Japanese Children and Adolescents With Depressive Disorder
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| ClinicalTrials.gov Identifier: NCT03315793 |
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Recruitment Status :
Recruiting
First Posted : October 20, 2017
Last Update Posted : October 4, 2018
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Sponsor:
Eli Lilly and Company
Collaborator:
Shionogi
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Depressive Disorder | Drug: Duloxetine Hydrochloride Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 148 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | December 4, 2017 |
| Estimated Primary Completion Date : | February 4, 2020 |
| Estimated Study Completion Date : | February 4, 2020 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Depression
| Arm | Intervention/treatment |
|---|---|
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Experimental: Duloxetine Hydrochloride
Duloxetine hydrochloride given orally.
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Drug: Duloxetine Hydrochloride
Administered orally
Other Name: LY248686 |
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Placebo Comparator: Placebo
Placebo given orally.
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Drug: Placebo
Administered orally |
Primary Outcome Measures :
- Mean Change from Baseline on the Children's Depression Rating Scale-Revised (CDRS-R) Total Score [ Time Frame: Baseline, Week 6 ]Mean change from baseline on the CDRS-R total score
Secondary Outcome Measures :
- Percentage of Participants Whose CDRS-R Total Score Decreased by More than 30% from Baseline [ Time Frame: Week 6 ]Percentage of participants whose CDRS-R total score decreased by more than 30% from baseline
- Percentage of Participants Whose CDRS-R Total Score Decreased by More than 50% from Baseline [ Time Frame: Week 6 ]Percentage of participants whose CDRS-R total score decreased by more than 50% from baseline
- Percentage of Participants with Total CDRS-R Score ≤ 28 [ Time Frame: Week 6 ]Percentage of participants with total CDRS-R score ≤ 28
- Mean Change from Baseline on Clinical Global Impression-Severity (CGI-S) [ Time Frame: Baseline, Week 6 ]Mean change from baseline on CGI-S
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| Ages Eligible for Study: | 9 Years to 17 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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).
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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
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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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03315793
Contacts
| Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | clinicaltrials.gov@lilly.com |
Locations
| Japan | |
| For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. | Recruiting |
| Kobe, Hyogo, Japan, 651-0086 | |
| Contact: Eli Lilly and Company | |
Sponsors and Collaborators
Eli Lilly and Company
Shionogi
Investigators
| Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
| Responsible Party: | Eli Lilly and Company |
| ClinicalTrials.gov Identifier: | NCT03315793 History of Changes |
| Other Study ID Numbers: |
14937 F1J-JE-B058 ( Other Identifier: Eli Lilly and Company ) |
| First Posted: | October 20, 2017 Key Record Dates |
| Last Update Posted: | October 4, 2018 |
| Last Verified: | October 1, 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Plan Description: | Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com. This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement. |
| Studies a U.S. FDA-regulated Drug Product: | Yes | |
| Studies a U.S. FDA-regulated Device Product: | No | |
| Product Manufactured in and Exported from the U.S.: | Yes | |
Additional relevant MeSH terms:
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Disease Depressive Disorder Depression Pathologic Processes Mood Disorders Mental Disorders Behavioral Symptoms Duloxetine Hydrochloride Serotonin and Noradrenaline Reuptake Inhibitors Neurotransmitter Uptake Inhibitors |
Membrane Transport Modulators Molecular Mechanisms of Pharmacological Action Neurotransmitter Agents Physiological Effects of Drugs Analgesics Sensory System Agents Peripheral Nervous System Agents Antidepressive Agents Psychotropic Drugs Dopamine Agents |