Ignite Creation Date:
2024-05-06 @ 3:58 AM
Last Modification Date:
2024-10-26 @ 11:41 AM
Study NCT ID:
NCT02422186
Status:
COMPLETED
Last Update Posted:
2021-09-29
First Post:
2015-04-16
Brief Title:
A Study to Evaluate the Efficacy Safety and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Participants With Treatment-resistant Depression
Sponsor:
Janssen Research Development LLC
Organization:
Janssen Research Development LLC
Study Overview
Official Title:
A Randomized Double-blind Multicenter Active-controlled Study to Evaluate the Efficacy Safety and Tolerability of Intranasal Esketamine Plus an Oral Antidepressant in Elderly Subjects With Treatment-resistant Depression
Status:
COMPLETED
Status Verified Date:
2021-08
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:
TRANSFORM-3
Brief Summary:
The purpose of this study is to evaluate the efficacy and safety of switching elderly participants with treatment-resistant depression TRD from a prior antidepressant treatment to which they have not responded to either intranasal esketamine plus a new oral antidepressant or switching to a new oral antidepressant plus intranasal placebo
Detailed Description:
This is a randomized double-blind neither the researchers nor the participants know what treatment the participant is receiving active-controlled multicenter study more than 1 study site in elderly participants with TRD to assess the efficacy safety and tolerability of flexible doses of intranasal esketamine plus a newly initiated oral antidepressant compared with a newly initiated oral antidepressant active comparator plus intranasal placebo The study will consist of 3 phases ScreeningProspective Observational Phase 4 to 7 weeks Double-blind induction Phase 4 weeks Follow up Phase 2 weeks Participants who rollover into a long-term open-label safety study will not participate in the Follow-up Phase At the start of the ScreeningProspective observational Phase participant must have had documented nonresponse to at least one antidepressant treatment based on Massachusetts General Hospital - Antidepressant Treatment Response Questionnaire MGH-ATRQ criteria in the current episode of depression and the participant is taking a different oral antidepressant treatment on the MGH-ATRQ for at least the previous 2 weeks at or above the minimum therapeutic dose This antidepressant treatment will be discontinued prior to the double-blind induction Phase Participants taking benzodiazepines at dosages equal to or less than the equivalent of 6 mgday of lorazepam andor permitted non-benzodiazepine sleep medications example zolpidem zaleplon during the screeningprospective observational phase can continue these medications All participants will start with first dose Day 1 as 28 milligram mg second dose Day 4 is either 28 or 56 mg All subsequent doses may be 28 56 or 84 mg After the first dose all dosing decisions are determined by the investigator based on efficacy and tolerability In addition each participant will be assigned to receive 1 of 4 oral antidepressant medications from 2 different classes of antidepressant treatments a Selective Serotonin Reuptake Inhibitor SSRI escitalopram or sertraline or a Serotonin and Norepinephrine Reuptake Inhibitor SNRI duloxetine or venlafaxine extended release XR initiated on Day 1 and continued through the double-blind induction Phase Participants will be primarily evaluated for improvement in depressive symptoms as assessed by change in Montgomery Asberg Depression Rating Scale MADRS total score at Week 4 Participants safety will be monitored throughout the study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2014-004588-19 | EUDRACT_NUMBER | Janssen Research Development LLC | None |
| ESKETINTRD3005 | OTHER | None | None |