A placebo-controlled, randomized, double-blind, multicenter study of venlafaxine in Japanese pediatric patients with MDD or PDD.

Authors
Category Primary study
Registry of TrialsJapan Primary Registry Network
Year 2022
INTERVENTION: Investigational product will be administered once a day. Participants unable to tolerate the minimum daily dose for their weight category are to be withdrawn from the study. CONDITION: Major Depressive Disorder and Persistent Depressive Disorder PRIMARY OUTCOME: Population‐based average treatment effect on change from baseline CDRS‐R score for venlafaxine INCLUSION CRITERIA: At the initiation of the screening period ‐Japanese male or female aged between 12 and 17 years at the initiation of the screening period (Visit 1). ‐Participants/parents who provided applicable written consent and written informed assent. ‐Outpatient participants. ‐Participants with a diagnosis of major depressive disorder or persistent depressive disorder based on the DSM‐5 diagnostic criteria. ‐Educational level and degree of understanding so that the participants and parents could communicate intelligibly with the investigator and study coordinator; normal intelligence based on the judgment of the investigator.
Epistemonikos ID: dee5438f52ee202e355ee98c3bfbca352b067a53
First added on: Aug 26, 2024