Ignite Creation Date:
2024-07-17 @ 11:25 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06462612
Status:
RECRUITING
Last Update Posted:
2024-06-17
First Post:
2024-06-12
Brief Title:
Study of Lumateperone in the 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:
RECRUITING
Status Verified Date:
2024-07
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:
This is a multicenter randomized double-blind placebo-controlled study in the acute treatment of patients with a diagnosis of bipolar I disorder with manic episodes or manic episodes with mixed features bipolar mania with or without psychotic symptoms according to criteria of the Diagnostic and Statistical Manual of Mental Disorders Fifth Edition DSM 5
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