Efficacy and Safety of AVE1625 as a co-Treatment With Antipsychotic Therapy in Schizophrenia - Full Text View

Purpose

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.

Condition	Intervention	Phase
Schizophrenia	Drug: AVE1625	Phase II

MedlinePlus related topics:

Schizophrenia

ChemIDplus related topics:

Risperidone Quetiapine Quetiapine fumarate Olanzapine Aripiprazole Paliperidone

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study

Official Title:	A 24-Week, Double-Blind, Randomized, Parallel-Group, Study of the Efficacy and Safety of 3 Oral Doses of AVE1625 on Top of Either Olanzapine, Risperidone/Paliperidone, Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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.

Estimated Enrollment:	700
Study Start Date:	February 2007
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	March 2010 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00439634

Contacts


Contact: Public Registry ICD		GV-Contact-us@sanofi-aventis.com

Locations


United States, Pennsylvania
	Sanofi-Aventis	Recruiting
	Malvern, Pennsylvania, United States, 19355
	Contact GV-Contact-us@sanofi-aventis.com

Canada
	Sanofi-Aventis Administrative Office	Recruiting
	Laval, Canada
	Contact GV-Contact-us@sanofi-aventis.com

Sponsors and Collaborators

Sanofi-Aventis

Investigators


Study Director:	ICD CSD	Sanofi-Aventis

More Information

Related Info This link exits the ClinicalTrials.gov site

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI6726, AVE1625
First Received:	February 22, 2007
Last Updated:	June 5, 2008
ClinicalTrials.gov Identifier:	NCT00439634
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

psychometrics

schizophrenia

Study placed in the following topic categories:

Schizophrenia

Quetiapine

Mental Disorders

Risperidone

Olanzapine

9-hydroxy-risperidone

Psychotic Disorders

Aripiprazole

Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on September 04, 2008

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00439634