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NCT01892189 · ClinicalTrials.gov registry record · Phase 1
Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults
A Phase 1 study, sponsored by Takeda.
- Completed
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
NCT01892189: Completed Phase 1 study, sponsored by Takeda.
NCT01892189 is a Phase 1 study that has completed, run by Takeda. The registered enrollment target is 27 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01892189, a Phase 1 study, has completed, sponsored by Takeda.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
Study 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.
Primary Outcome
Ketamine model was used to enhance the sensitivity to detect an effect of phosphodiesterase 10a (PDE10a) inhibition by TAK-063 by ketamine using neuroimaging battery tests. Ketamine induced robust blood oxygen level-dependent(BOLD) functional magnetic resonance imaging(fMRI) response while maintaining minimal accompanying psychotomimetic symptoms. The regions of interest include:left anterior cingulate cortex,right anterior cingulate cortex,left posterior cingulate cortex,right posterior cingula
Interventions
- DRUG Ketamine
- DRUG TAK-063
- DRUG TAK-063 Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2013-08 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01892189 record still lists
NCT01892189 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (55% lower).
The record links to 0 conditions, and to 3 interventions - of which Ketamine is the first listed.
NCT01892189 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01892189 about?
NCT01892189 is a clinical study titled "Effects of TAK-063 on Preventing Ketamine-Induced Brain Activity Changes as Well as Psychotic-Like Symptoms in Healthy Male Adults". The purpose of this study is to determine whether ketamine-induced brain activity changes are modulated by TAK-063 administration using neuroimaging battery tests.
What is the current status of trial NCT01892189?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2013-08. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01892189?
The interventions under investigation include: Ketamine (DRUG), TAK-063 (DRUG), TAK-063 Placebo (DRUG).
Who is sponsoring clinical trial NCT01892189?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01892189's enrollment target sits among peer trials
27 1463rd of 2000 higher than 519 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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