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Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults

NCT01892189 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2026-05-08

Study results available
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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.

Conditions

  • Ketamine-Induced Brain Activity Changes
  • Psychotic-like Symptoms

Interventions

DRUG

Ketamine

Ketamine intravenous administration.

DRUG

TAK-063

TAK-063 tablets

DRUG

TAK-063 Placebo

TAK-063 placebo-matching tablets

Sponsors & Collaborators

Principal Investigators

  • Medical Director · Takeda Development Center Americas, Inc. (Note: This product was divested to Axsome in 2026)

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2014-08-31
Completion
2014-08-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01892189 on ClinicalTrials.gov