Depressive DisorderPhase 3NCT03395353

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

A Phase 3 study testing Duloxetine Hydrochloride in people with Depressive Disorder, run by Shionogi at 1 site in Japan.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder. Read more about this study

Who is it for?: Ages 9 to 17 years
Conditions the study is for: Depressive Disorder
What is being tested?: Duloxetine Hydrochloride
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 151 participants
Where: 1 siteJapan
Study dates: 29 Jan 2018to 4 Jul 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
b) 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.
b) Participants whose incipient age of depression was ≥7 years old.

Who cannot join

a, b) 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

Show all 13Show fewer

a, b) 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
a, b) Have personality disorders, in the judgment of the investigator.

Trial locations and contacts

1 site in 1 country.

Japan1 site

Shionogi
Osaka, 541-0045

Other trials in Japan

About this study

Official title: A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.

Conditions: Depressive Disorder
Being tested: Duloxetine Hydrochloride
Medical subject headings: Depressive Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Duloxetine HydrochlorideDrug
Also called LY248686
Administered orally

Study groups in NCT03395353
Study group	Role	What they receive
Duloxetine hydrochloride	Experimental	Duloxetine hydrochloride administered orally. Receives: Drug: Duloxetine Hydrochloride

What is being measured

The primary outcome is the main question the study is designed to answer.

Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.
Measured: Baseline through Week 53

Secondary outcomes (3)

Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
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.
Measured: Baseline, Week 50
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
CGI-S measures severity of illness at the time of assessment compared with start of treatment with scores ranging from 1 (normal, not at all ill) to 7 (among the most extremely ill participants).
Measured: Baseline, Week 50
Pharmacokinetics (PK): Trough Concentration of Duloxetine
Trough concentrations of duloxetine are defined as the plasma concentrations in 18 - 30 hours post the previous dose. PK samples were obtained from each subject from Week 4 to the end of treatment period (Week 50) for analysis of steady state duloxetine concentrations. If duloxetine dose changed, PK samples were taken after 2 week or more administration of the new dose. Principally 1 or 2 blood samples were drawn from each subject at pre-dose for trough concentrations.
Measured: Week 4 through Week 50

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

29 Jan 20184 Jul 2020

First posted10 Jan 2018
Study start29 Jan 2018
Primary completion4 Jul 2020
Study completion4 Jul 2020

Why it stopped: Business decision

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Depressive DisorderStudies of the same condition, open and under way.
More trials run by ShionogiThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 151 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03395353
Sponsor's protocol ID: 16916
Other IDs: F1J-JE-HMHF, 1702A3632
Status last verified: May 2021
First submitted: 4 Jan 2018
Last updated: 18 Jun 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Shibata RY, Kubota R, Uenaka K, Kaibara A, Wajima T. Population pharmacokinetics of duloxetine in Japanese pediatric patients with major depressive disorder. Drug Metab Pharmacokinet. 2023 Aug;51:100496. doi: 10.1016/j.dmpk.2023.100496. Epub 2023 Feb 15.
PubMed 37244205

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Depressive Disorder trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Long-term Safety Study of Duloxetine Hydrochloride in the Treatment of Japanese Children and Adolescents With Depressive Disorder
ClinicalTrials.gov ID: NCT03395353
Acronym / sponsor ID: 16916
Conditions: Depressive Disorder
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: Business decision
Enrolment: 151 participants (actual)
Lead sponsor: ShionogiIndustry (pharma, biotech, devices)
Collaborators: Eli Lilly and Company
Study start: 29 Jan 2018 (actual)
Primary completion: 4 Jul 2020 (actual)
Study completion: 4 Jul 2020 (actual)
First posted: 10 Jan 2018 (actual)
Results: Posted 18 Jun 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The purpose of this long-term study is to evaluate the safety and efficacy of duloxetine hydrochloride in Japanese children and adolescents with depressive disorder.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Duloxetine hydrochloride	Experimental	Drug: Duloxetine HydrochlorideDuloxetine hydrochloride administered orally.

Who may qualify

Ages: 9 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (3 listed)

a) Participants who have completed 7 weeks of dosing in the B058(1701A3631) study and give signed informed consent to continue duloxetine administration in this study.
b) 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.
b) Participants whose incipient age of depression was ≥7 years old.

Key exclusion criteria (13 listed)

a, b) Have a current or previous diagnosis (DSM-5) of the following as judged by the investigator:
a, b) Have a current diagnosis (DSM-5) of the following as judged by the investigator:
a, b) Have personality disorders, in the judgment of the investigator.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Duloxetine HydrochlorideAlso: LY248686Administered orally	Drug	Duloxetine hydrochloride

Primary outcome

Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)
Time frame: Baseline through Week 53
A summary of AEs, ADRs (considered by the investigator) and SAEs is located in the Reported Adverse Events module. An AE was included if the onset date is on or after the first dose of study drug and within 7 days after the last dose, or it is consecutive from the preceding study at the initiation of study drug administration in this study.

3 secondary outcomes

Change From Baseline on the Children's Depression Rating Scale-Revised (CDRS-R)
Time frame: Baseline, Week 50
Change From Baseline on the Clinical Global Impression-Severity of Illness (CGI-S)
Time frame: Baseline, Week 50
Pharmacokinetics (PK): Trough Concentration of Duloxetine
Time frame: Week 4 through Week 50

Results and safety

Results posted to the registry on 18 Jun 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Duloxetine	151	64

Primary outcome: Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs)

Time frame: Baseline through Week 53. Number. Unit: percentage of participants

Measure	Duloxetine n = 150
Serious Adverse Event	2
Adverse Event including Serious Adverse Event	89.3
Drug-Related Adverse Event	73.3

Population analysed: All enrolled participants who received at least one dose of study drug.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline to 53 Weeks. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Duloxetine	3 of 150 (2%)	134 of 150 (89.3%)	0 of 150

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37244205Shibata RY, Kubota R, Uenaka K, Kaibara A, Wajima T. Population pharmacokinetics of duloxetine in Japanese pediatric patients with major depressive disorder. Drug Metab Pharmacokinet. 2023 Aug;51:100496. doi: 10.1016/j.dmpk.2023.100496. Epub 2023 Feb 15.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Shionogi Clinical Trials Administrator Clinical Support Help Line study director

Shionogi

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Duloxetine Hydrochloride in people with Depressive Disorder, run by Shionogi at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Adverse Events (AEs), Drug Related Adverse Events (ADRs) or Any Serious Adverse Events (SAEs) (time frame: Baseline through Week 53). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03395353, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2021.