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

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.

Status

Terminated

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00439634

Acronym

CONNECT

Enrollment

873

Registered

2007-02-23

Start date

2007-02-28

Completion date

2009-09-30

Last updated

2016-05-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Keywords

psychometrics, 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 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.

Interventions

DRUGAVE1625

oral administration

DRUGplacebo

oral administration

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame
Change from baseline in the MATRICS Cognitive Battery composite standardized score	at week 24

Secondary

Measure	Time frame
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

Countries

Canada, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026