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

Phase 2

Terminated

• Conditions: Schizophrenia
• Interventions: Drug: placebo; Drug: AVE1625

• Registration Number: NCT00439634
• Lead Sponsor: Sanofi

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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-02
• Study First Submitted: 2007-02-22
• Study First Submitted QC: 2007-02-22
• Study First Posted: 2007-02-23
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2016-04
• Disposition First Submitted: 2016-04-18
• Disposition First Submitted QC: 2016-04-18
• Last Update Submitted: 2016-04-18
• Disposition First Posted: 2016-05-18
• Last Update Posted: 2016-05-18

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 873

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	-
AVE1625 dose level 1	AVE1625	-
AVE1625 dose level 3	AVE1625	-
AVE1625 dose level 2	AVE1625	-

Primary Outcome Measures

Name	Time	Method
Change from baseline in the MATRICS Cognitive Battery composite standardized score	at week 24

Secondary Outcome Measures

Name	Time	Method
Change from baseline in the UPSA2 total score	at week 24
Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events	study period
Additional scales used for schizophrenia	at week 24

Trial Locations

Locations (1)

Sanofi-Aventis Administrative Office; 🇨🇦 Laval, Canada