Ignite Creation Date:
2024-07-17 @ 10:53 AM
Last Modification Date:
2025-12-17 @ 7:21 PM
Study NCT ID:
NCT06462586
Status:
None
Last Update Posted:
2025-07-01 00:00:00
First Post:
2024-06-12 00:00:00
Brief Title:
Study of Lumateperone in the Acute Treatment of Patients With Bipolar Mania
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies, Inc.
Study Overview
Official Title:
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)
Status:
None
Status Verified Date:
2025-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The study will be conducted in 3 phases:
* Screening Period (up to 1 week) during which patient eligibility will be assessed.
* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit
* Screening Period (up to 1 week) during which patient eligibility will be assessed.
* Double-blind Treatment Period (3 weeks) during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 1:1 ratio.
* Safety Follow-up Period (1 week) during which all patients will return to the clinic for a safety follow-up visit
Detailed Description:
The study will be conducted in 3 phases
Screening Period up to 1 week during which patient eligibility will be assessed
Double-blind Treatment Period 3 weeks during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 11 ratio
Safety Follow-up Period 1 week during which all patients will return to the clinic for a safety follow-up visit
Screening Period up to 1 week during which patient eligibility will be assessed
Double-blind Treatment Period 3 weeks during which all eligible patients will be randomized to receive lumateperone 42 mg or placebo in 11 ratio
Safety Follow-up Period 1 week during which all patients will return to the clinic for a safety follow-up visit
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None