Last updated on July 2019

A Study to Evaluate Efficacy Safety Tolerability and Pharmacokinetics of 3 Dose Levels of TAK-831 in Adjunctive Treatment of Adult Participants With Negative Symptoms of Schizophrenia


Brief description of study

The purpose of this study is to determine whether add-on TAK-831 is superior to placebo on the Positive and Negative Syndrome Scale Negative Symptom Factor Score (PANSS NSFS).

Detailed Study Description

The drug being tested in this study is called TAK-831. TAK-831 is being tested to treat negative symptoms in participants who have schizophrenia.

The study will enroll approximately 234 participants. Participants will then be randomly assigned (by chance, like flipping a coin) to one of the four treatment groups in the double-blind periodwhich will remain undisclosed to the participant and study doctor during the study (unless there is an urgent medical need):

  • TAK-831 50 mg once daily
  • TAK-831 125 mg once daily
  • TAK-831 500 mg once daily
  • Placebo once daily

This multi-center trial will be conducted in the United States, Spain, Italy, Czech Republic, Poland, Bulgaria and Ukraine. The overall time to participate in this study is approximately 20 weeks. Participants will make 11 visits to the clinic, and will be followed up for safety assessment 10 to 14 days after the last dose of study drug (Day 98).

Clinical Study Identifier: NCT03382639

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Synergy Clinical Research Center

Chula Vista, CA United States
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Excell Research

Oceanside, CA United States
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NRC Research Institute

Orange, CA United States
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CNRI - San Diego, LLC

San Diego, CA United States
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Augusta University

Augusta, GA United States
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Center for Behavioral Health, LLC

Gaithersburg, MD United States
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Cherry Health

Grand Rapids, MI United States
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Manhattan Psychiatric Center

New York, NY United States
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Core Clinical Research

Everett, WA United States
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Care Clinic

Katowice, Poland
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Synergy Clinical Research Center

Lemon Grove, CA United States
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Recruitment Status: Open


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