drugset / Trial / NCT02477020
A Phase 2 Efficacy and Safety Study of TAK-063 in Participants With an Acute Exacerbation of Schizophrenia
RandomizedParallel-groupQuadruple-blindTreatment
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.
Timeline
- Start
- 2015-07-01
- Primary completion
- 2016-07-13
- Completion
- 2016-07-27
Publications
- Macek TA, McCue M, Dong X, Hanson E, Goldsmith P, Affinito J, Mahableshwarkar AR. A phase 2, randomized, placebo-controlled study of the efficacy and safety of TAK-063 in subjects with an acute exacerbation of schizophrenia. Schizophr Res. 2019 Feb;204:289-294. doi: 10.1016/j.schres.2018.08.028. Epub 2018 Sep 3.
- Tohyama K, Sudo M, Morohashi A, Kato S, Takahashi J, Tagawa Y. Pre-clinical Characterization of Absorption, Distribution, Metabolism and Excretion Properties of TAK-063. Basic Clin Pharmacol Toxicol. 2018 Jun;122(6):577-587. doi: 10.1111/bcpt.12964. Epub 2018 Feb 26.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | BALIPODECT | Small molecule | 20 mg | Oral |