Ignite Creation Date:
2024-05-06 @ 8:21 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06340958
Status:
RECRUITING
Last Update Posted:
2024-06-21
First Post:
2024-03-25
Brief Title:
A Study of CLE-100 Oral Esketamine as an Adjunctive Treatment to Standard Antidepressants for Major Depressive Disorder
Sponsor:
Clexio Biosciences Ltd
Organization:
Clexio Biosciences Ltd
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Multicenter Parallel-Design Phase 2 Study to Assess the Efficacy and Safety of CLE-100 as an Adjunctive Treatment for Major Depressive Disorder Patients With Inadequate Response to Standard Antidepressants
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:
SOLEO
Brief Summary:
The study is a Phase 2 double-blind randomized placebo-controlled study in Major Depressive Disorder MDD participants with an inadequate response to standard antidepressants The objective of the study is to assess CLE-100 oral esketamine for the treatment of MDD in participants currently treated with an oral antidepressant medication and who have an inadequate response to at least 2 antidepressants
Detailed Description:
This is a Phase 2 study in subjects with MDD currently treated with an oral antidepressant medication with an inadequate response to at least 2 antidepressants SOLEO will be an outpatient study to assess the safety efficacy and tolerability of CLE-100 as compared to placebo
Eligible subjects will be randomized to receive either placebo or CLE-100 oral esketamine once daily in addition to their current oral antidepressant monotherapy for 4 weeks All subjects who adequately completed the 4-week Double-Blind Treatment Period and who meet the eligibility criteria will be offered the option to roll-over to a 6-month Open-label Extension OLE Treatment Period with CLE-100
Eligible subjects will be randomized to receive either placebo or CLE-100 oral esketamine once daily in addition to their current oral antidepressant monotherapy for 4 weeks All subjects who adequately completed the 4-week Double-Blind Treatment Period and who meet the eligibility criteria will be offered the option to roll-over to a 6-month Open-label Extension OLE Treatment Period with CLE-100
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