An open-label extension study of duloxetine in children and adolescents with depressive disorder

An open-label extension study of phase 3 clinical trial of duloxetine in children and adolescents with depressive disorder

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080223797

Enrollment

135

Registered

2018-02-05

Start date

2018-01-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depressive disorder

Interventions

investigational material(s) Generic name etc : LY248686 INN of investigational material : Duloxetine Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Consecutive Participants: Patients who have completed the 7-week treatment in the preceding study (A phase 3 clinical trial of duloxetine in children and adolescents with depressive disorder) New Participants: Patients who diagnosed with major depressive disorder or persistent depressive disorder as defined by Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) and completely meet the criteria of major depressive episode. And et al.

Exclusion criteria

Exclusion criteria: Patients who have allergies to two or more medicines or have a history of severe allergic reactions with medicines. And et al.

Design outcomes

Primary

Measure	Time frame
safety The incidence of both adverse events and adverse drug reactions	—

Secondary

Measure	Time frame
efficacy pharmacokinetics Change from baseline in Children's Depression Rating Scale-Revised (CDRS-R) total score. And et al.	—

Countries

Japan

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026