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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00439634
Recruitment Status : Terminated (Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy)
First Posted : February 23, 2007
Last Update Posted : May 18, 2016
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: AVE1625 Drug: placebo Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 873 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : February 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Placebo Comparator: Placebo Drug: placebo
oral administration

Experimental: AVE1625 dose level 1 Drug: AVE1625
oral administration
Other Name: Drinabant

Experimental: AVE1625 dose level 2 Drug: AVE1625
oral administration
Other Name: Drinabant

Experimental: AVE1625 dose level 3 Drug: AVE1625
oral administration
Other Name: Drinabant

Primary Outcome Measures :
  1. Change from baseline in the MATRICS Cognitive Battery composite standardized score [ Time Frame: at week 24 ]

Secondary Outcome Measures :
  1. Change from baseline in the UPSA2 total score [ Time Frame: at week 24 ]
  2. Additional scales used for schizophrenia [ Time Frame: at week 24 ]
  3. Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events [ Time Frame: study period ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00439634

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United States, New Jersey
Sanofi-Aventis Administrative Office
Bridgewater, New Jersey, United States, 08807
Sanofi-Aventis Administrative Office
Laval, Canada
Sponsors and Collaborators
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Study Director: ICD CSD Sanofi

Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Sanofi Identifier: NCT00439634    
Other Study ID Numbers: DRI6726
First Posted: February 23, 2007    Key Record Dates
Last Update Posted: May 18, 2016
Last Verified: April 2016
Keywords provided by Sanofi:
Additional relevant MeSH terms:
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Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders