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

Schizophrenia Clinical Trial

— CONNECT  

Official title:

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.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00439634
• Other study ID #: DRI6726
• Status: Terminated
• Phase: Phase 2
• First received: February 22, 2007
• Last updated: May 11, 2010
• Start date: February 2007
• Est. completion date: September 2009

Study information

• Verified date: May 2010
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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 MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) in schizophrenic patients.

The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called UPSA2 (University of California San Diego Performance-based Skills Assessment 2) and to assess the safety of the compound.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 873
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• AVE1625
oral administration
• placebo
oral administration

Locations

Country	Name	City	State
Canada	Sanofi-Aventis Administrative Office	Laval
United States	Sanofi-Aventis Administrative Office	Bridgewater	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the MATRICS Cognitive Battery composite standardized score		at week 24	No
Secondary	Change from baseline in the UPSA2 total score		at week 24	No
Secondary	Additional scales used for schizophrenia		at week 24	No
Secondary	Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events		study period	Yes