General Information
Forest MDD 02
A Randomized, Double-Blind, Placebo-Controlled, Relapse Prevention Study with Vilazodone in Patients with Major Depressive Disorder
| Protocol | VLZ-MD-02 |
|---|---|
| Identifier | VLZ-MD-02 Site Number 012 |
| UID | b7b43188-b819-4596-ac1a-da01f48dd353 |
| Status | Done - Archived |
| Phase | 4 |
| Category | Major Depressive Disorder / Adult |
| Launch Year | 2012 |
| NCT Number | - |
| Created | 2012-03-02 14:39 |
| Last Updated | 2012-03-02 14:39 |
Description
Key Elements: • To evaluate the efficacy, safety, and tolerability of vilazodone (Viibryd™) in preventing of depression relapse in patients with major depressive disorder (MDD) in comparison with placebo. Viibryd™ is already FDA approved for MDD in adults. • Patient will be randomized to 1 of 3 treatment groups (placebo, vilazodone 20 mg/day, vilazodone 40 mg/day) in a 1:1:1 ratio • Study drug administration: One tablet once-daily in the morning with food • 29 Visits/52 Weeks • Stipend: $40 per completed visit
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2013-11-22 | No |
| Enrollment Open | 2012-04-27 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2012-04-12 | No |
| PI Meeting Start | 2012-03-15 | No |
| PI Meeting End | 2012-03-16 | No |
| PI Meeting Arrival | 2012-03-14 | No |
| PI Meeting Departure | 2012-03-16 | No |
| Closeout Date | 2015-02-12 | No |
| Final PatientVisit | No | |
| PreStudy Selection Visit | No | |
| Target Date 12 | No | |
| Target Date 13 | No | |
| Target Date 14 | No |
Leadership
| Role | Staff | Login | Required |
|---|---|---|---|
| Principal | Martinez, Gilbert | GJMartinez | No |
| Recruiter | - | No | |
| Coordinator | Pereira, Cynthia | CPereira | No |
| Regulatory | Aguirre, Sandra | SAguirre | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Forest Research Institute |
|---|---|
| Division | Forest Research Institute |
| Team | Forest Research Institute |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | FOR1-12-077 |
|---|---|
| CRO | |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
