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

Primary Purpose

Schizophrenia

Status

Terminated

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

AVE1625

placebo

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring psychometrics, schizophrenia

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Sanofi-Aventis Administrative Office
Sanofi-Aventis Administrative Office

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

AVE1625 dose level 1

AVE1625 dose level 2

AVE1625 dose level 3

Arm Description

Outcomes

Primary Outcome Measures

Change from baseline in the MATRICS Cognitive Battery composite standardized score

Secondary Outcome Measures

Change from baseline in the UPSA2 total score

Additional scales used for schizophrenia

Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events

Full Information

NCT ID

NCT00439634

First Posted

February 22, 2007

Last Updated

April 18, 2016

Sponsor

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT00439634

Brief Title

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

Acronym

CONNECT

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.

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

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

Study Start Date

February 2007 (undefined)

Primary Completion Date

September 2009 (Actual)

Study Completion Date

September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Sanofi

4. Oversight

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Schizophrenia

Keywords

psychometrics, schizophrenia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

873 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Title

AVE1625 dose level 1

Arm Type

Experimental

Arm Title

AVE1625 dose level 2

Arm Type

Experimental

Arm Title

AVE1625 dose level 3

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

AVE1625

Other Intervention Name(s)

Drinabant

Intervention Description

oral administration

Intervention Type

Drug

Intervention Name(s)

placebo

Intervention Description

oral administration

Primary Outcome Measure Information:

Title

Change from baseline in the MATRICS Cognitive Battery composite standardized score

Time Frame

at week 24

Secondary Outcome Measure Information:

Title

Change from baseline in the UPSA2 total score

Time Frame

at week 24

Title

Additional scales used for schizophrenia

Time Frame

at week 24

Title

Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events

Time Frame

study period

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

ICD CSD

Organizational Affiliation

Sanofi

Official's Role

Study Director

Facility Information:

Facility Name

Sanofi-Aventis Administrative Office

City

Bridgewater

State/Province

New Jersey

ZIP/Postal Code

08807

Country

United States

Facility Name

Sanofi-Aventis Administrative Office

City

Laval

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

28433500

Citation

Georgiades A, Davis VG, Atkins AS, Khan A, Walker TW, Loebel A, Haig G, Hilt DC, Dunayevich E, Umbricht D, Sand M, Keefe RSE. Psychometric characteristics of the MATRICS Consensus Cognitive Battery in a large pooled cohort of stable schizophrenia patients. Schizophr Res. 2017 Dec;190:172-179. doi: 10.1016/j.schres.2017.03.040. Epub 2017 Apr 20.

Results Reference

derived

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

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