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A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia

Schizophrenia Clinical Trial

Official title:
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Parallel-group, 6-Week Study to Evaluate the Efficacy and Safety of TAK-063 in Subjects With an Acute Exacerbation of Schizophrenia

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy, safety and tolerability of TAK-063 compared with placebo in treatment of acutely exacerbated schizophrenia.

Clinical Trial Description

The drug being tested in this study is called TAK-063. TAK-063 is being tested to treat people who have schizophrenia. This study will look at the different symptoms associated with schizophrenia including cognitive symptoms, personal and social functioning and functional capacity (ability to perform tasks associated with real, everyday life such as household chores, communication, finance, transportation, and planning recreational activities) in people who take TAK-063.

The study enrolled 164 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups—which will remain undisclosed to the patient and study doctor during the study (unless there is an urgent medical need):

- TAK-063 20 mg

- Placebo (dummy inactive pill) - this is a tablet that looks like the study drug but has no active ingredient.

All participants will be asked to take the tablets once daily at nighttime. All participants will initially receive TAK-063, 20 mg/day. The dose may be titrated down to 10 mg/day, if intolerable.

The multi-center trial will be conducted in the United States. The overall time to participate in this study is 6 weeks. Participants will be hospitalized until the Week 3 visit. Participants will make 11 visits to the clinic during the treatment and 1 visit during the follow-up. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT02477020
Study type Interventional
Source Takeda
Contact
Status Completed
Phase Phase 2
Start date July 1, 2015
Completion date July 27, 2016
View Details
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