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

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

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 Drug: placebo	Phase II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	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.

Resource links provided by NLM:

MedlinePlus related topics: Schizophrenia

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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 ]

Estimated Enrollment:	692
Study Start Date:	February 2007
Study Completion Date:	October 2009
Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Group I: Placebo Comparator	Drug: placebo oral administration
Group II: Experimental dose level 1	Drug: AVE1625 oral administration
Group III: Experimental dose level 2	Drug: AVE1625 oral administration
Group IV: Experimental dose level 3	Drug: AVE1625 oral administration

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

Locations

United States, New Jersey
Sanofi-aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Canada
Sanofi-aventis Administrative Office
Laval, Canada

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

ICD CSD

Sanofi-Aventis

More Information

No publications provided

Responsible Party:	Sanofi-aventis ( ICD Study Director )
Study ID Numbers:	DRI6726
Study First Received:	February 22, 2007
Last Updated:	October 27, 2009
ClinicalTrials.gov Identifier:	NCT00439634 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Sanofi-Aventis:

psychometrics
schizophrenia

Additional relevant MeSH terms:

Schizophrenia
Mental Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on November 22, 2009