Efficacy and Safety of TAK-653 in Treatment-Resistant Depression
Research type
Research Study
Full 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
IRAS ID
234381
Contact name
Rupert McShane
Contact email
Sponsor organisation
Millennium Pharmaceuticals, Inc, a wholly owned subsidiary of Takeda Pharmaceutical Company, Ltd
Eudract number
2017-002232-16
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
IND Number, 134,863
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
Major depressive disorder (MDD), also known simply as depression, is characterised by low mood that is present across most situations. MDD can negatively affect a person's personal and work life, as well as sleeping, eating habits, and general health. Therefore, MDD has been identified as the second leading cause of years lived with disability, designating it as a major public health priority.
In participants who respond to treatment, there is a time lag of several weeks to months before a therapeutic effect is observed, a serious problem given the high rate of suicide in patients with depression. Furthermore, in participants who achieved remission, the mean time to remission was 6.7 weeks. Thus, there is a significant unmet medical need for novel antidepressant therapies with faster onset of action and improved efficacy in patients with TRD.
Approximately 90 participants will be randomised into this study. Patients who meet the study entry criteria will be assessed for response to ketamine by administering 2 intravenous (IV) infusions of ketamine on Day -5 and Day -1. Response to ketamine will be used to stratify patients; responders into Cohort 1 (54 participants) and non-responders into Cohort 2 (up to 40 participants). Participants in both cohorts will receive TAK-653 or placebo for 8 weeks in a double-blind manner. The dose for participants randomised to TAK-653 will be up-titrated to 6 mg once daily during the first week of treatment as follows: TAK-653 2 mg once daily on Days 1 and 2, TAK-653 4 mg once daily on Days 3 and 4, and TAK-653 6 mg once daily for the remainder of the Treatment Period. Participants not on TAK-653 will be given a placebo to match (PTM) TAK-653.
The duration of the treatment period of this study is approximately 8 weeks. The maximum number of days for screening, prior to the beginning of the treatment period, could be 28 days.
REC name
South Central - Berkshire B Research Ethics Committee
REC reference
17/SC/0606
Date of REC Opinion
15 Dec 2017
REC opinion
Further Information Favourable Opinion