Design Module
The Design Module contains detailed information about the study design, including study type, allocation methods, intervention models, masking information, primary purpose, enrollment details, and biospecimen information. This module provides essential details about how the clinical trial is structured and conducted.
Design Module path is as follows:
Study -> Protocol Section -> Design Module
Design Module
Ignite Creation Date:
2025-12-24 @ 11:48 AM
Ignite Modification Date:
2025-12-24 @ 11:48 AM
NCT ID:
NCT01575561
Study Type:
INTERVENTIONAL
Allocation:
NA
Primary Purpose:
TREATMENT
Study:
NCT01575561
Study Brief:
This is an Open-label, Multi-center, Extension Study Designed to Evaluate the Longer Term Safety, Tolerability and Effectiveness of Lurasidone, Flexibly Dosed, Adjunctive to Lithium or Divalproex for the Treatment of Subjects With Bipolar I Disorder Who Have Participated in Study D1050296
Protocol Section:
NCT01575561
Bio Specs (If Any):
Design Masking Infos (If Any):
Design Masking Infos
| Design Masking Brief | View |
|---|---|
| None | View |
Design Observational Models (If Any):
Design Time Perspectives (If Any):
Design Who Masked (If Any):
Enrollment Infos (If Any):
Enrollment Infos
| Enrollment Type | Enrollment Count | View |
|---|---|---|
| ACTUAL | 377 | View |
Expanded Access Types (If Any):
Phases (If Any):
Phases
| Phase Brief | Phase Text | View |
|---|---|---|
| None | PHASE3 | View |