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Study to evaluate safety and efficacy of Venlafaxine in treating MDD or PDD in children who completed VENL-CAZ-3001 study

An open-label, long-term extension, multicenter study to evaluate the safety and efficacy of venlafaxine in Japanese pediatric outpatients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD) who completed study VENL-CAZ-3001.

Status
Unknown
Phases
Phase 3
Study type
Interventional
Source
EU CTR
Registry ID
EUCTR2024-000605-33-Outside-EU/EEA
Enrollment
Unknown
Registered
2026-03-17
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-23

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

Conditions

Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD) MedDRA version: 21.1 Level: PT Classification code 10057840 Term: Major depression System Organ Class: 10037175 - Psychiatric disorders

Interventions

Trade Name: Effexor SR Pharmaceutical Form: Capsule INN or Proposed INN: Venlafaxine CAS Number: 93413-69-5 Concentration unit: mg milligram(s) Concentration type: range Concentration number: 37.5-225

Sponsors

Viatris Pharmaceutical Japan GK
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Japanese pediatric outpatients who had no serious protocol violations and who completed 8-10 weeks of treatment including tapering period in the placebo-controlled, double-blind comparative study of venlafaxine SR and who tolerated the investigational product well. Are the trial subjects under 18? yes Number of subjects for this age range: 145 F.1.2 Adults (18-64 years) no F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: 1. Patients with clinically significant abnormalities on physical examinations at approximate Wweek 8-10 Visit of the double-blind comparative study, or patients with clinically significant ECG, clinical laboratory test, or vital sign abnormalities that were recorded before Week 8-10 of the preceding double-blind comparative study and that have not resolved. 2. Patients identified as CYP2D6 poor metabolizers (PM) during the double-blind comparative study (VENL-CAZ-3001). 3. Patients clinically determined to be at risk for suicide.

Design outcomes

Primary

MeasureTime frame
Primary end point(s): The safety endpoints include: •Incidence of adverse events (AEs). •Body weight, vital signs, clinical laboratory tests (hematology tests, chemistry tests and urinalysis [qualitative] tests), standard 12-lead electrocardiogram (ECG). •Frequency of participants with suicidal ideation or suicidal behavior using Columbia-Suicide Severity Rating Scale (C-SSRS).;Timepoint(s) of evaluation of this end point: Week 52;Main Objective: Investigate the safety and tolerability of the long-term use of venlafaxine SR (37.5 to 225 mg/day) in Japanese pediatric patients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD).;Secondary Objective: Investigate the efficacy of the long-term use of venlafaxine SR (37.5 to 225 mg/day) in Japanese pediatric patients with Major Depressive Disorder (MDD) or Persistent Depressive Disorder (PDD).—

Secondary

MeasureTime frame
Secondary end point(s): Secondary endpoints include: • Childhood Depression Rating Scale – Revised (CDRS-R) • Clinical Global Impressions-Severity of Illness (CGI-S) • Clinical Global Impressions Global Improvement (CGI-I);Timepoint(s) of evaluation of this end point: Week 52—

Countries

Japan

Contacts

Public ContactGlobal Clinical Operation

Viatris Pharmaceutical Japan GK

japan.communication@viatris.com81356560400

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Apr 3, 2026