Ignite Creation Date:
2024-05-05 @ 5:21 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00439634
Status:
TERMINATED
Last Update Posted:
2016-05-18
First Post:
2007-02-22
Brief Title:
Efficacy and Safety of AVE1625 as a Co-treatment With Antipsychotic Therapy in Schizophrenia
Sponsor:
Sanofi
Organization:
Sanofi
Study Overview
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 RisperidonePaliperidone Quetiapine or Aripiprazole in the Treatment of Cognitive Impairment in Schizophrenia
Status:
TERMINATED
Status Verified Date:
2016-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Following a pre-specified interim analysis and Data Monitoring Committee recommendation due to insufficient level of efficacy
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CONNECT
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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None