Ignite Creation Date:
2024-05-06 @ 8:25 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06372964
Status:
RECRUITING
Last Update Posted:
2024-04-23
First Post:
2024-04-15
Brief Title:
Multicenter Study of Lumateperone for the Treatment of Bipolar Depression in Pediatric Patients
Sponsor:
Intra-Cellular Therapies Inc
Organization:
Intra-Cellular Therapies Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Lumateperone for the Treatment of Major Depressive Episodes MDEs Associated With Bipolar I or Bipolar II Disorder Bipolar Depression in Pediatric Patients Aged 10 to 17 Years
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 pediatric patients who are experiencing major depressive episodes MDEs associated with a primary diagnosis of bipolar I or bipolar II disorder as confirmed by Kiddie Schedule for Affective Disorders and Schizophrenia for School-Age Children-Present and Lifetime Version K-SADS-PL 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 2 weeks during which patient eligibility will be assessed
Double-blind Treatment Period 6 weeks during which all patients will be randomized to receive lumateperone 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 SFU visit approximately one week after the last dose of study drug
Screening Period up to 2 weeks during which patient eligibility will be assessed
Double-blind Treatment Period 6 weeks during which all patients will be randomized to receive lumateperone 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 SFU visit approximately one week after the last dose of study drug
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