General Information
Intra-Cellular Bipolar 451
A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Lumateperone in the Acute Treatment of Patients with Manic Episodes or Manic Episodes with Mixed Features Associated with Bipolar I Disorder (Bipolar Mania)
| Protocol | ITI-007-451 |
|---|---|
| Identifier | |
| UID | 37f992b3-5eed-4cbd-b180-1aecc896dcdf |
| Status | Follow-up |
| Phase | 3 |
| Category | Bipolar Disorder / Adult |
| Launch Year | 2024 |
| NCT Number | - |
| Created | 2024-05-24 11:37 |
| Last Updated | 2025-08-04 16:14 |
Description
No description provided.
Comment
No comment.
Target Dates
| Name | Date | Required |
|---|---|---|
| Enrollment Closed | No | |
| Enrollment Open | 2024-09-23 | No |
| First Patient First Visit | No | |
| Site Initiation Mtg. | 2024-09-18 | No |
| PI Meeting Start | No | |
| PI Meeting End | No | |
| PI Meeting Arrival | No | |
| PI Meeting Departure | No | |
| Closeout Date | 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 | Gomez, Kathie | KGomez | No |
| Coordinator | Sandoval, Larry | LSandoval | No |
| Regulatory | Ramirez, Claudia | CRamirez | No |
Custom Fields
No custom fields.
Sponsor & Organization
| Sponsor | Intra-Cellular Therapies |
|---|---|
| Division | Intra-Cellular Therapies |
| Team | Intra-Cellular Therapies |
| Managing Site | Catalina Research Institute, LLC |
| Organization |
Contacts
| IRB Ref | |
|---|---|
| CRO | IQVIA RDS Inc. |
| CRO Ref | |
| Correspondence | 0 |
Opportunity
| Probability | 0 |
|---|---|
| Comment | |
| Status Color | PaleGoldenrod |
| Currency | - |
