Status:
TERMINATED
Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia
Lead Sponsor:
Sanofi
Conditions:
Schizophrenia
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
873 Patients enrolled
Trial Details
Trial ID
NCT00439634
Start Date
February 1 2007
End Date
September 1 2009
Last Update
May 18 2016
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
2
Sanofi-Aventis Administrative Office
Laval, Canada