Ignite Creation Date:
2024-05-06 @ 12:38 AM
Last Modification Date:
2024-10-26 @ 10:53 AM
Study NCT ID:
NCT01627782
Status:
COMPLETED
Last Update Posted:
2020-06-02
First Post:
2012-06-22
Brief Title:
A Study of Ketamine in Patients With Treatment-resistant Depression
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Double-blind Randomized Placebo-controlled Parallel Group Dose Frequency Study of Ketamine in Subjects With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2020-05
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:
The purpose of this study is to explore the optimal dose frequency of ketamine in patients with treatment-resistant depression TRD
Detailed Description:
This is a double-blind patients and study personnel do not know the identity of the administered treatments randomized the drug is assigned by chance placebo-controlled placebo is a substance that appears identical to the treatment and has no active ingredients parallel arm study each group of patients will be treated at the same time The study will consist of a screening phase of up to 4 weeks a 4-week double-blind treatment phase Day 1 to Day 29 and a 3-week post treatment follow up phase In the double-blind phase patients will receive over 4 weeks either intravenous IV infusions of placebo 2 or 3 times weekly or IV infusions of ketamine 2 or 3 times weekly The total study duration for each patient will be a maximum of 13 weeks
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
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 |
|---|---|---|---|
| KETIVTRD2002 | OTHER | Janssen Research Development LLC | None |