Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-01 @ 12:15 PM
Study NCT ID:
NCT02129751
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-09-17
First Post:
2014-04-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Sponsor:
Bausch Health Americas, Inc.
Organization:
Study Overview
Official Title:
A Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety of Bupropion Hydrobromide in Adolescents and Children With Major Depressive Disorder
Status:
NOT_YET_RECRUITING
Status Verified Date:
2025-09
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:
Double-Blind, Placebo-Controlled, Multicenter Study of Efficacy and Safety
Detailed Description:
* The primary efficacy endpoint is the mean change from Baseline to EOT in total CDRS-R (raw) score.
* The secondary efficacy endpoints include:
* Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
* Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \<29)
* Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
* Incidence of AEs
* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
* Treatment discontinuation due to AEs
* Suicidality as assessed by the C-SSRS score
* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
* The secondary efficacy endpoints include:
* Proportion of subjects characterized as responders at EOT (≥40% improvement from Baseline total CDRS-R raw score)
* Proportion of subjects characterized as in remission at EOT (total CDRS-R raw score \<29)
* Mean change from Baseline to EOT in CGI-C.
Safety endpoints include:
* Incidence of AEs
* Change from Baseline to EOT in vital signs (blood pressure and radial pulse rate), blood and urine laboratory panel, and ECG
* Treatment discontinuation due to AEs
* Suicidality as assessed by the C-SSRS score
* Change from Baseline to EOT in sleep as assessed by the sleep subscale of the CDRS-R.
Study Oversight
Has Oversight DMC:
False
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?: