General Information
Janssen MDD 3001
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled, Study to Evaluate the Efficacy and Safety of Seltorexant 20 mg as Adjunctive Therapy to Antidepressants in Adult and Elderly Patients with Major Depressive Disorder with Insomnia Symptoms Who Have Responded Inadequately to Antidepressant Therapy and an Open-labeled Long-term Safety Extension Treatment with Seltorexant
| Protocol | 42847922MDD3001 |
|---|---|
| Identifier | |
| UID | 2d5cb18a-65a8-47f5-b4be-953e2530da01 |
| Status | Done - Archived |
| Phase | 3 |
| Category | Major Depressive Disorder / Adult |
| Launch Year | 2020 |
| NCT Number | - |
| Created | 2020-06-03 17:05 |
| Last Updated | 2022-10-10 22:49 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | 2021-05-05 | No |
| Enrollment Open | 2021-03-31 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2020-09-30 | No |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 2022-06-29 | 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 | Volk, Stephen | SVolk | No |
| Recruiter | - | No | |
| Coordinator | Martinez, Cassandra | CMartinez1 | No |
| Regulatory | - | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Janssen |
|---|---|
| Division | Janssen |
| Team | Janssen |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | |
|---|---|
| CRO | IQVIA RDS Inc. |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | Gainsboro |
| Currency | - |
