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

This study has been terminated.
(Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy)
Sponsor:
Information provided by:
Sanofi
ClinicalTrials.gov Identifier:
NCT00439634
First received: February 22, 2007
Last updated: May 11, 2010
Last verified: May 2010

February 22, 2007
May 11, 2010
February 2007
September 2009   (final data collection date for primary outcome measure)
Change from baseline in the MATRICS Cognitive Battery composite standardized score [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
The primary efficacy criterion is the MATRICS Cognitive Battery composite standardized score
Complete list of historical versions of study NCT00439634 on ClinicalTrials.gov Archive Site
  • Change from baseline in the UPSA2 total score [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Additional scales used for schizophrenia [ Time Frame: at week 24 ] [ Designated as safety issue: No ]
  • Safety: physical examination, vital signs, ECGs, laboratory parameters, adverse events [ Time Frame: study period ] [ Designated as safety issue: Yes ]
The key secondary efficacy criterion is the UPSA2 total score. Additional scales used for schizophrenia are included to evaluate efficacy/safety. Safety endpoints include: physical examination, vital signs, ECGs, Laboratory parameters.
Not Provided
Not Provided
 
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.

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 MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia) in schizophrenic patients.

The secondary objectives are to measure the efficacy of AVE1625 on functional capacity of the patients using a specific scale called UPSA2 (University of California San Diego Performance-based Skills Assessment 2) and to assess the safety of the compound.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Schizophrenia
  • Drug: AVE1625
    oral administration
  • Drug: placebo
    oral administration
  • Placebo Comparator: Group I
    Intervention: Drug: placebo
  • Experimental: Group II
    dose level 1
    Intervention: Drug: AVE1625
  • Experimental: Group III
    dose level 2
    Intervention: Drug: AVE1625
  • Experimental: Group IV
    dose level 3
    Intervention: Drug: AVE1625
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
873
September 2009
September 2009   (final data collection date for primary outcome measure)

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.

Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Canada
 
NCT00439634
DRI6726
Not Provided
ICD Study Director, Sanofi-aventis
Sanofi
Not Provided
Study Director: ICD CSD Sanofi
Sanofi
May 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP