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

Tracking Information

First Received Date ^ICMJE

February 22, 2007

Last Updated Date

October 27, 2009

Start Date ^ICMJE

February 2007

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Change from baseline in the MATRICS Cognitive Battery composite standardized score [ Time Frame: at week 24 ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

The primary efficacy criterion is the MATRICS Cognitive Battery composite standardized score

Change History

Complete list of historical versions of study NCT00439634 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Change from baseline in the UPSA2 total score [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
Additional scales used for schizophrenia [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

The key secondary efficacy criterion is the UPSA2 total score. Additional scales used for schizophrenia are included to evaluate efficacy/safety. Safety endpoints include: physical examination, vital signs, ECGs, Laboratory parameters.

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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.

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 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.

Detailed Description

Study Phase

Phase II

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: AVE1625
Drug: placebo

Study Arms / Comparison Groups

Experimental: dose level 1
Experimental: dose level 2
Experimental: dose level 3

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Estimated Enrollment ^ICMJE

692

Completion Date

October 2009

Primary Completion Date

October 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

18 Years to 65 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States, Canada

Administrative Information

NCT ID ^ICMJE

NCT00439634

Responsible Party

ICD Study Director, Sanofi-aventis

Study ID Numbers ^ICMJE

DRI6726

Study Sponsor ^ICMJE

Sanofi-Aventis

Collaborators ^ICMJE

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi-Aventis

Information Provided By

Sanofi-Aventis

Verification Date

October 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP