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

Sanofi

Status and phase: Terminated; Phase 2

Conditions: Schizophrenia

Treatments: Drug: placebo; Drug: AVE1625

Study type: Interventional

Funder types: Industry

Identifiers

NCT00439634

DRI6726

Details and patient eligibility

About

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.

Enrollment: 873 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

873 participants in 4 patient groups, including a placebo group

Placebo

Placebo Comparator group

Treatment:

Drug: placebo

AVE1625 dose level 1

Experimental group

Treatment:

Drug: AVE1625

AVE1625 dose level 2

Experimental group

Treatment:

Drug: AVE1625

AVE1625 dose level 3

Experimental group

Treatment:

Drug: AVE1625