A clinical trial of MLD-55 in pediatric patients with depression

A Phase 3 clinical trial of MLD-55 in pediatric patients with depression

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2080224520

Enrollment

Registered

2019-01-15

Start date

2019-02-15

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

Major depressive disorder

Interventions

investigational material(s) Generic name etc : MLD-55 INN of investigational material : escitalopram Therapeutic category code : 117 Psychotropic agents Dosage and Administration for Investigational m

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Patients with a primary diagnosis of major depressive disorder or persistent depressive disorder completely meeting the criteria of major depressive episode throughout the preceding 1 year according to Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)

Exclusion criteria

Exclusion criteria: (1)Patients with a complication or history of any of the following DSM-5-classified diseases: - Bipolar and related disorders - Schizophrenia spectrum and other psychotic disorders (2)Patients with a history of suicidal behavior (suicide attempt, interrupted suicide attempts) based on C-SSRS within one year prior to screening.

Design outcomes

Primary

Measure	Time frame
safety efficacy - Efficacy Time to relapse - Safety Adverse events	—

Secondary

Measure	Time frame
safety efficacy pharmacokinetics - Efficacy Relapse Change in CDRS-R total score - Safety Adverse Reactions - Pharmacokinetics Plasma levels of escitalopram	—

Countries

Japan

Outcome results

None listed

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