Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Schizophrenia
In brief
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.
Key facts
- Study ID
- NCT00439634
- Run by
- Sanofi
- People needed
- 873
- Starts
- 2007-02-01
- Expected to finish
- 2009-09-01
- Last updated by the study team
- 2016-05-18
Who can join
Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Sanofi-Aventis Administrative Office — Bridgewater, New Jersey, United States
- Sanofi-Aventis Administrative Office — Laval, Canada
Full record on ClinicalTrials.gov
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