At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 27 enrolled
Drug / intervention
Ketamine +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Randomized, Investigator and Subject-Blind, Placebo-Controlled, Single-Dose, 3-Period, Incomplete Block Cross-Over Study to Evaluate the Effects of Single Oral Administration of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
In Brief
A Phase 1 clinical trial evaluating Ketamine, TAK-063, and 1 other intervention for Ketamine-Induced Brain Activity Changes and Psychotic-like Symptoms. Completed, enrolled 27 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--
Timeline
Phase 1CompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedJul 2013
Enrollment StartAug 2013
Primary CompletionAug 2014
TodayJul 2026
First PostedJul 4, 2013
Enrollment StartAug 1, 2013
Primary CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 1 yearPosted 13.0 years ago
Interventions
Ketaminedrug
Ketamine intravenous administration.
TAK-063drug
TAK-063 tablets
TAK-063 Placebodrug
TAK-063 placebo-matching tablets