Evaluation of TAK-058 and Ondansetron on P50 Auditory Gating in Participants With Stable Schizophrenia

Stopped early · Phase 1 · Has a placebo group

Conditions studied: Schizophrenia

In brief

The purpose of this study is to determine whether improvement in P50 (a pharmacodynamic marker) in auditory sensory gating is demonstrated after administration of TAK-058 and ondansetron compared to placebo in participants with schizophrenia.

Key facts

Study ID

NCT02614586

Run by

Takeda

People needed

11

Starts

2015-12-01

Expected to finish

2016-04-01

Last updated by the study team

2017-05-01

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• 18 to 60 years of healthy and schizophrenic participants, inclusive, at the time of informed consent.
• Has acceptable clinical laboratory evaluations (including clinical chemistry, hematology and complete urinalysis).
• Meets schizophrenia criteria as defined by the Diagnostic \& Statistical Manual of Mental Disorders, 5th Edition (DSM-V).
• Are on a stable dose of single second-generation antipsychotics (SGA) for at least 2 months prior to Screening as documented by medical history and assessed by site staff.
• Demonstrates Positive and Negative Syndrome Scale (PANSS) total score of less than equal to (<=) 85.
• Has a P50 ratio of > 0.5 at both screening assessments.

You may not qualify if…

• Has a history in the last year or currently receiving treatment with clozapine or olanzapine.
• Has taken any excluded medications, supplements or food products.
• Has a history of gastrointestinal disease that would influence the absorption of study drug or have a significant medical history of any disease that would contraindicate the administration of TAK-058, ondansetron, or a similar compound.
• Has substance abuse or dependence within previous 12 months, unstable mood or anxiety disorder.
• Has a current diagnosis of a significant psychiatric illness other than schizophrenia per DSM-V and is in an acute phase/episode.
• Has clinically meaningful hearing loss per investigator's judgment.

Where it is running

• Study site — St Louis, Missouri, United States

Full record on ClinicalTrials.gov

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