Agomelatin/Studien

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This is a list of all Servier-sponsored clinical trials with Agomelatine known to exist. Details of some trials are readily available and will be added later. Most trials remain unpublished and only few studies were publicly registered.

Trial codea) public registrationb) EudraCTd) scopee) intervention vs. comparator (dose) endpoint (scale) result sec. result(s) publication remarks
CL1-003 n.a.                
CL2-005 ISRCTN38378163                
CL2-006 none                
CL2-007 none             Encephale. 2003;29(2): 165-71. previously published
CL2-008 none                
CL2-009 none 2009-014045-92              
CL2-010 none                
CL2-011 none   (Alzheimer's)           Deaths: AGO 14, PLA 1
CL2-012 none                
CL2-013 none                
CL2-014 none             Int Clin Psychopharmacol. 2002;17(5): 239-47.  
CL2-015 none               Deaths: AGO 1, PLA 0
CL2-017 none                
CL2-018 none                
CL3-021 none                
CL3-022 none                
CL3-023 none                
CL3-024 none                
CL3-025 none                
CL3-026 none   Efficacy in elderly patients AGO (25mg) vs. PLA MDD (MADRS) negative      
CL3-027 none                
CL1-028 n.a.                
CL3-029 none                
CL3-030 none             Int Clin Psychopharmacol. 2004;19(5): 271-80.  
CL1-032 n.a.                
CL1-033 n.a.                
CL1-034 n.a.                
CL3-035 none             J Clin Psychiatry. 2007;68(11): 1723-32.  
CL3-036 none             J Clin Psychopharmacol. 2008;28(3): 329-33.  
CL3-037 none                
CL3-038 none                
CL1-039 n.a.                
CL2-040 none 2004-002577-23           J Clin Psychopharmacol. 2008;28(5): 561-6.  
CL3-041 ISRCTN53193024c) 2004-003981-13           J Clin Psychiatry 2009;70(8): 1128-37.  
CL3-042 none             Int J Neuropsychopharmacol. 2007;10(5): 661-73.  
CL3-043 none             Eur Neuropsychopharmacol. 2006;16(2): 93-100.  
CL2-044 none                
CL3-045 ISRCTN19313268c) 2004-004008-19           Int Clin Psychopharmacol 2010;25(6): 305-14.  
CL3-046 ISRCTN49376288c) 2004-004009-10       positive AGO better than SER on HAMD J Clin Psychiatry 2010;71(2): 109-20.  
CL3-047 ISRCTN28588282 2005-004881-17              
CL3-048 ISRCTN68222771 2005-002388-95              
CL1-049 n.a.     Sexual tolerability in healthy volunteers AGO vs. PLA positive   J Psychopharmacol. 2010;24(1): 111-20.  
CL3-050 ISRCTN38094599 2006-005674-47              
CL3-052 none                
CL1-054 n.a.                
CL3-056 ISRCTN44737909 2006-004716-48              
CL3-062 ISRCTN96725312 2008-004642-92              
CL3-063 ISRCTN55250367 2006-006540-54              
CL2-067 ISRCTN53505070 2007-005564-27              
CLE-068 ISRCTN53570733
CL3-069 ISRCTN10845256 2009-011238-84              
CL3-070 ISRCTN57507360 2009-011795-29              
CL3-071 ISRCTN03554974 2009-013789-17              
CL2-072 NCT01108393 2009-016713-20              
CL3-073 ISRCTN97599615 2010-019556-44              
  • a)originally given by Servier in CLx-20098-xxx format; bold: pivotal trials
  • b)n.a.: not applicable (phase I), none: not registered
  • c)trials which were registered at or after completion, their subsequent publication was therefore not in line with ICMJE regulations
  • d)as of April 20th 2011
  • e)short description of trial/design

Bioavailibility and pharmacokinetic trials, i.e. PKH-010, -014, -015, -66 and many more, were now dropped from this list, as were other non-interventional (CLE-068) and open phase IV marketing trials (DM4-10x) Last updated: Apr 23 2011

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