Venlafaxine long-term extension in MDD or PDD who completed study VENL-CAZ-3001

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

Recruiting

Phases

Phase 3

Study type

Interventional

Source

JPRN

Registry ID

JPRN-jRCT2031220357

Enrollment

145

Registered

2022-10-04

Start date

2023-06-01

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 and Persistent Depressive Disorder

Interventions

Venlafaxine (37.5 - 225 mg/day depending on the weight) will be administered once a day according to the predefined dose escalation schedule. Participants unable to tolerate the minimum daily dose for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Japanese pediatric outpatients who had no serious protocol violations and who completed treatment including tapering period in the placebo-controlled, double-blind comparative study of venlafaxine SR. - Patients who consent to practice adequate means of contraception during the study and for at least 28 days after the final dose of the investigational product (except for women who are not capable of becoming pregnant). - Participants/ parents who provided applicable written consent and who provided written informed assent. - Patients who are willing to participate in the study, come in for the planned visits, undergo the treatment plan and tests, and adhere to all of the other clinical study procedures.

Exclusion criteria

Exclusion criteria: - Patients with clinically significant abnormalities on physical examinations or patients with clinically significant ECG, clinical laboratory test, or vital sign abnormalities. - Patients clinically determined to be at risk for suicide. - ECG showing clinically significant rate or rhythm abnormalities or QTcF >500msec. - Patients using prohibited concomitant medications or receivingprohibited therapy. - Patients wanting to participate in another clinical study while participating in this clinical study. - Patients with other severe, acute/chronic medical/psychiatric conditions and/or clinical laboratory test abnormalities of which clinical study participation/investigational product administration could increase the risks, or that could affect the interpretation of the study results, or other patients deemed unsuitable for participation in the study by the investigators.

Design outcomes

Primary

Measure	Time frame
Descriptive statistics corresponding to each separate safety endpoint will be presented for all subjects who take at least 1 dose of study intervention in this extension study.	—

Contacts

Public ContactClinical trial contact

ICON Clinical Research GK

Japan-Chiken@iconplc.com+81-6-4560-2001

Outcome results

None listed

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