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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Schizophrenia

Intervention / Treatment
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* Drug: AVE1625
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* oral administration<br>|
| Experimental: AVE1625 dose level 1<br> | Drug: AVE1625<br>* oral administration<br>* Other names: Drinabant;|
| Experimental: AVE1625 dose level 2<br> | Drug: AVE1625<br>* oral administration<br>* Other names: Drinabant;|
| Experimental: AVE1625 dose level 3<br> | Drug: AVE1625<br>* oral administration<br>* Other names: Drinabant;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the MATRICS Cognitive Battery composite standardized score |  | at week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the UPSA2 total score |  | at week 24 | 
| Additional scales used for schizophrenia |  | at week 24 | 
| Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events |  | study period | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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psychometrics, schizophrenia