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

A 24-Week, Multicenter, Double-Blind, Randomized, Parallel-Group, Dose Ranging Study of the Efficacy and Safety of 3 Oral Doses of AVE1625 and Placebo on Top of Either Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia.

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.

Inclusion Criteria:

• Outpatients with diagnosis of schizophrenia (diagnosed ≤ 35 years of age).
• Current treatment consisting exclusively of olanzapine, risperidone/paliperidone, quetiapine or aripiprazole monotherapy for at least 2 months.

Exclusion Criteria:

• Inpatient hospitalization within past 3 months.
• Residence at the current address < 3 months due to any instability in the disease.
• Presence of depressive symptoms.
• Past history of clinically significant violent behavior.
• Substance dependence or abuse.
• Pregnant or breast-feeding women or women not protected by effective contraceptive method of birth control.

The investigator will evaluate whether there are other reasons why a patient may not participate.