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

This study has been terminated.

(Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy)

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00439634

First received: February 22, 2007

Last updated: May 11, 2010

Last verified: May 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

February 22, 2007

Last Updated Date

May 11, 2010

Start Date ^ICMJE

February 2007

Primary Completion Date

September 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.

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

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

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment

Condition ^ICMJE

Schizophrenia

Intervention ^ICMJE

Drug: AVE1625
oral administration
Drug: placebo
oral administration

Study Arm (s)

Placebo Comparator: Group I
Intervention: Drug: placebo
Experimental: Group II
dose level 1

Intervention: Drug: AVE1625
Experimental: Group III
dose level 2

Intervention: Drug: AVE1625
Experimental: Group IV
dose level 3

Intervention: Drug: AVE1625

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Terminated

Enrollment ^ICMJE

873

Completion Date

September 2009

Primary Completion Date

September 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 Number ^ICMJE

NCT00439634

Other Study ID Numbers ^ICMJE

DRI6726

Has Data Monitoring Committee

Not Provided

Responsible Party

ICD Study Director, Sanofi-aventis

Study Sponsor ^ICMJE

Sanofi

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Director:

ICD CSD

Sanofi

Information Provided By

Sanofi

Verification Date

May 2010

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

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