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
Conditions
Interventions
Trade Name: Effexor SR
Pharmaceutical Form: Capsule
Pharmaceutical form of the placebo: Capsule
Route of administration of the placebo: Oral use
Sponsors
Viatris Pharmaceutical Japan GK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Japanese male or female aged between 12 and 17 years at the initiation of the screening period (Visit 1). 2. Participants/parents who provided applicable written informed consent and written informed assent. 3. Outpatient participants. 4. Participants with a diagnosis of MDD or PDD based on the DSM-5 diagnostic criteria. Are the trial subjects under 18? yes Number of subjects for this age range: 160 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. Participants who have received any prior treatment with venlafaxine or desvenlafaxine. 2. Participants with known hypersensitivity to venlafaxine or desvenlafaxine. 3. Participants with a history or presence of clinically significant cardiac, hepatic, renal, respiratory, endocrinological, neurological, or hematological disease. 4. Participants with a history or complication of ocular tension increased or acute narrow-angle glaucoma. 5. Participants with a history or presence of other medical disease that might compromise the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate superiority vs. placebo of anti-depressant effect of Venlafaxine (37.5-225 mg/day) in pediatric patients with major depressive disorder (MDD) or persistent depressive disorder (PDD).;Secondary Objective: Evaluate the safety and tolerability of venlafaxine (37.5-225 mg/day) in pediatric patients with major depressive disorder (MDD) or persistent depressive disorder (PDD).;Primary end point(s): The primary endpoint will be the estimated population-based average treatment effect on change from baseline children depression rating scale-revised (CDRS-R) score for Venlafaxine relative to placebo at Week 8 for the adolescent population (12-17 years old) under the assumption that participants who drop out follow the same evolution of the disease as other non-dropout participants in their respective treatment group who remain in the study.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): The secondary estimand (s) will be the estimated population-based average treatment effect on secondary efficacy, safety, and Pharmacokinetic (PK) endpoints for the adolescent population (12-17 years old) under the assumption that participants who drop out follow the same evolution of the disease as other non-dropout participants in their respective treatment group who remain in the study.;Timepoint(s) of evaluation of this end point: Week 8 | — |
Countries
Japan
Contacts
Public ContactGlobal Clinical Operation
Viatris Pharmaceutical Japan GK
Outcome results
None listed