Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2026-03-01 @ 2:44 AM
Study NCT ID:
NCT03312894
Status:
WITHDRAWN
Last Update Posted:
2018-02-22
First Post:
2017-10-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of TAK-653 in Treatment-Resistant Depression
Sponsor:
Millennium Pharmaceuticals, Inc.
Organization:
Study Overview
Official Title:
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of TAK-653 in the Treatment of Subjects With Treatment-Resistant Depression
Status:
WITHDRAWN
Status Verified Date:
2018-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision
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 evaluate the efficacy of TAK-653 compared with placebo in maintaining the effect of ketamine treatment on depressive symptoms.
Detailed Description:
The drug being tested in this study is called TAK-653. TAK-653 is being tested to treat people who have depression and have not responded to several treatments (treatment-resistant depression).
This study will look at the efficacy and safety of TAK-653 in participants with treatment-resistant depression who take TAK-653 in addition to standard care.
The study will enroll approximately 90 patients. Participants who meet the study entry criteria will be assessed for response to ketamine by administering 2 intravenous (IV) infusions of ketamine (0.5 mg/kg given over 40 minutes; maximum dose 40 mg/day) on Day -5 (±1) and Day -1 (±1). To determine response to ketamine, the Day -5 predose Montgomery Åsberg Depression Rating Scale (MADRS) total score (before the first ketamine infusion) will be compared with the MADRS total score predose on Day 1 (24 hours after the second ketamine infusion on Day -1). Two cohorts (ketamine responders and ketamine nonresponders) of participants will be enrolled in parallel into the study.
Participants will then be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups - which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
* TAK-653
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one tablet at the same time each day throughout the study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 78 days. Participants will make multiple visits to the clinic, and will be contacted by telephone on Day 78 after last dose of study drug for a follow-up assessment.
This study will look at the efficacy and safety of TAK-653 in participants with treatment-resistant depression who take TAK-653 in addition to standard care.
The study will enroll approximately 90 patients. Participants who meet the study entry criteria will be assessed for response to ketamine by administering 2 intravenous (IV) infusions of ketamine (0.5 mg/kg given over 40 minutes; maximum dose 40 mg/day) on Day -5 (±1) and Day -1 (±1). To determine response to ketamine, the Day -5 predose Montgomery Åsberg Depression Rating Scale (MADRS) total score (before the first ketamine infusion) will be compared with the MADRS total score predose on Day 1 (24 hours after the second ketamine infusion on Day -1). Two cohorts (ketamine responders and ketamine nonresponders) of participants will be enrolled in parallel into the study.
Participants will then be randomly assigned (by chance, like flipping a coin) to one of the two treatment groups - which will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):
* TAK-653
* Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.
All participants will be asked to take one tablet at the same time each day throughout the study. This multi-center trial will be conducted worldwide. The overall time to participate in this study is 78 days. Participants will make multiple visits to the clinic, and will be contacted by telephone on Day 78 after last dose of study drug for a follow-up assessment.
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?: