Conditions: Schizophrenia
Keywords: Drug Therapy
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 164
Healthy volunteers: no

Brief 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.

Detailed 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.

Arms:
arm 1: TAK-063 20 mg, tablets, orally, once daily for up to 6 weeks. Dose may be titrated down to 10 mg/day, if intolerable. arm 2: TAK-063 matching-placebo tablets, orally, once daily for up to 6 weeks.

Interventions: intervention 1: TAK-063 20 mg intervention 2: Placebo
Intervention descriptions: intervention 1: TAK-063 tablet. intervention 2: TAK-063 matching-placebo tablet.

Protocol document: