Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:10 AM
Study NCT ID:
NCT01913535
Status:
TERMINATED
Last Update Posted:
2017-07-02
First Post:
2013-07-30
Brief Title:
Proof-of-Concept Trial of CERC-501 Augmentation of Antidepressant Therapy in Treatment-Resistant Depression
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Double-Blind Placebo-Controlled Proof-of-Concept POC Trial of CERC-501 a Kappa-Selective Opioid Receptor Antagonist Augmentation of Antidepressant Therapy in Treatment-Resistant Depression TRD
Status:
TERMINATED
Status Verified Date:
2017-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RAPID KOR
Brief Summary:
This study is looking at the efficacy rapidity safety and tolerability of two doses of oral CERC-501 for treating patients with treatment resistant depression who are taking an antidepressant that is not working for them
Detailed Description:
This study will involve 10 visits to the clinical site over approximately 15 months There will be a screening visit 7-28 days may pass between the screening visit and the first treatment visit a baselinetreatment visit first day of study drug treatment followed by 5 consecutive days of treatment visits Follow-up visits will occur 6 13 and 20 days after first receiving study drug
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 271201100006I-0-27100007-1 | NIH | None | httpsreporternihgovquickSearch271201100006I-0-27100007-1 |