Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia

Summary

AVE1625 is a new potent and selective cannabinoid 1 (CB1) antagonist in clinical development for the treatment of cognitive impairment in patients diagnosed with schizophrenia. The main objective of this study is to evaluate the efficacy on cognitive impairment of 3 doses of AVE1625 using a new cognitive battery called Measurement and Treatment Research to Improve Cognition in Schizophrenia (MATRICS) in schizophrenic patients. The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called University of California San Diego Performance-based Skills Assessment 2 (UPSA2) and to assess the safety of the compound.

Timeline

Start

2007-02

Primary completion

2009-09

Completion

2009-09

Outcome

Outcome not reported

Stopped: “Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy”

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.

Drugs

Indications