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

JRCT ID: jRCT2031220357

Registered date:04/10/2022

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Major Depressive Disorder and Persistent Depressive Disorder
• Date of first enrollment: 01/06/2023
• Target sample size: 145
• Study type: Interventional
• Intervention(s): 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 Participants unable to tolerate the minimum daily dose for their weight category are to be withdrawn from the study. Minimum dose are 37.5 mg for 25-39 kg weight category and 75 mg for 40-49kg as well as for >=50kg weight category.

Outcome(s)

• Primary Outcome: 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.

Key inclusion & exclusion criteria

• Age minimum: >= 12age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Brydun Andrey