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

Phase 3

Recruiting

• Conditions: Major Depressive Disorder and Persistent Depressive Disorder

• Registration Number: JPRN-jRCT2031220357
• Lead Sponsor: Brydun Andrey

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-10-04
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 145

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

- 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.