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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE2

Total Enrollment

873 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-02-28

Study Completion Date

2009-09-30

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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Placebo

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type DRUG

oral administration

AVE1625 dose level 1

Group Type EXPERIMENTAL

AVE1625

Intervention Type DRUG

oral administration

AVE1625 dose level 2

Group Type EXPERIMENTAL

AVE1625

Intervention Type DRUG

oral administration

AVE1625 dose level 3

Group Type EXPERIMENTAL

AVE1625

Intervention Type DRUG

oral administration

Interventions

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AVE1625

oral administration

Intervention Type DRUG

placebo

oral administration

Intervention Type DRUG

Other Intervention Names

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Drinabant

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No