20101299: Study to Evaluate the Effect of AMG 747 on Schizophrenia Negative Symptoms

Summary

The purpose of this study is to evaluate the effect of AMG 747 on negative symptoms of schizophrenia in patients who are stable on current antipsychotic treatment. After a run-in period on their current antipsychotic treatment, patients will be randomized to one of the four treatment arms as add-on therapy for a treatment duration of up to 3 months.

Timeline

Start

2012-05

Primary completion

2013-06

Completion

2013-06

Outcome

Missed primary endpoint

Stopped: “Toxic Epidermal Necrolysis”

paper Significant treatment effects of 15-mg AMG 747, but not higher or lower doses, were observed on secondary endpoints but not on the primary outcome. PMID 27789188 ↗

Publications

• Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.
• Dunayevich E, Buchanan RW, Chen CY, Yang J, Nilsen J, Dietrich JM, Sun H, Marder S. Efficacy and safety of the glycine transporter type-1 inhibitor AMG 747 for the treatment of negative symptoms associated with schizophrenia. Schizophr Res. 2017 Apr;182:90-97. doi: 10.1016/j.schres.2016.10.027. Epub 2016 Oct 24.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	AMG 747	Unknown	5 mg	Oral
Subject	AMG 747	Unknown	15 mg	Oral
Subject	AMG 747	Unknown	40 mg	Oral

Indications