NCT00439634

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.

Trial Health

60
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
873

participants targeted

Target at P75+ for phase_2 schizophrenia

Timeline
Completed

Started Feb 2007

Typical duration for phase_2 schizophrenia

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2007

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 23, 2007

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

May 18, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

February 22, 2007

Last Update Submit

April 18, 2016

Conditions

Schizophrenia

Keywords

psychometricsschizophrenia

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in the MATRICS Cognitive Battery composite standardized score

    at week 24

Secondary Outcomes (3)

  • Change from baseline in the UPSA2 total score

    at week 24

  • Additional scales used for schizophrenia

    at week 24

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

    study period

Study Arms (4)

Placebo

PLACEBO COMPARATOR
Drug: placebo

AVE1625 dose level 1

EXPERIMENTAL
Drug: AVE1625

AVE1625 dose level 2

EXPERIMENTAL
Drug: AVE1625

AVE1625 dose level 3

EXPERIMENTAL
Drug: AVE1625

Interventions

AVE1625DRUG

oral administration

Also known as: Drinabant
AVE1625 dose level 1AVE1625 dose level 2AVE1625 dose level 3
placeboDRUG

oral administration

Placebo

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sanofi-Aventis Administrative Office

Bridgewater, New Jersey, 08807, United States

Location

Sanofi-Aventis Administrative Office

Laval, Canada

Location

Related Publications (1)

  • 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.

    PMID: 28433500DERIVED

MeSH Terms

Conditions

Schizophrenia

Interventions

AVE1625

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Study Officials

  • ICD CSD

    Sanofi

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2007

First Posted

February 23, 2007

Study Start

February 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

May 18, 2016

Record last verified: 2016-04

Locations

CA(1)US(1)