Download PDF
Nervenheilkunde 2015; 34(10): 809-817
DOI: 10.1055/s-0038-1627629
Übersichtsartikel
Schattauer GmbH

Effekte von Agomelatin bei depressiven Patienten im Praxisalltag

Ergebnisse der nicht interventionellen Studie VIVREEffects of agomelatine in depressive patients in daily medical practiceResults of the non-interventional study VIVRE
H.-P. Volz
1   Krankenhaus für Psychiatrie, Psychotherapie und Psychosomatische Medizin, Schloss Werneck, Werneck
,
M.-L. Escafit-Schülke
2   SERVIER Deutschland GmbH, Medical Affairs, München
› Author Affiliations
Further Information

Publication History

eingegangen am: 09 March 2015

Akzeptiert nach Revision: 28 May 2015

Publication Date:
22 January 2018 (online)

Also available at
    Permissions and Reprints

Zusammenfassung

Gegenstand und Ziel: Die nicht interventionelle Studie VIVRE (Valdoxan® ImproVes depRession with anxiEty symptoms) untersuchte, inwieweit das Antidepressivum Agomelatin (Valdoxan®) unter Praxisbedingungen auch soziale Funktionsfähigkeit und Angstsymptome depressiver Patienten beeinflusst. Methoden: 1 891 depressive Patienten wurden mit Agomelatin von 616 Ärzten drei Monate behandelt. Clinical-Global-Impressions (CGI) Skala, Patient-Global-Impressions (PGI) Skala, COVIAngst-Skala und Sheehan-Disability-Scale (SDS) wurden eingesetzt. Ergebnisse: Laut CGI und PGI lag die Responderrate jeweils bei 82,1% bzw. 73,1%, die Remissionrate jeweils bei 39,9% bzw. 47,6%. Angstsymptome der Depression verbesserten sich in allen COVIItems bei über 80% der Patienten. Die soziale Funktionsfähigkeit verbesserte sich in den SDSBereichen Arbeit/Schule, soziale Kontakte und Familienleben/Häusliche Verpflichtungen bei über 90% der Patienten. Die Verträglichkeit von Agomelatin wurde bei 98,2% der Patienten als “sehr gut/gut” bewertet. UAWs traten bei 2,6% der Patienten auf. Schlussfolgerung: Agomelatin zeigte im Praxisalltag eine umfassende Wirkung auf depressive Symptome, Angstsymptome der Depression und soziale Funktionsfähigkeit bei guter Verträglichkeit.

Summary

Objective: The non-interventional study VIVRE investigated under naturalistic conditions the antidepressant effects of agomelatine (Valdoxan®), as well as its effects on psychosocial functioning and depression-related anxiety symptoms. Methods: 1 891 depressive patients were treated with agomelatine by 616 physicians for three months. The Clinical Global Impressions (CGI) Scale, the Patient Global Impressions (PGI) Scale, the COVI Anxiety Scale and the Sheehan Disability Scale (SDS) were implemented. Results: According to CGI and PGI, the responder rates were 82.1% and 73.1%, respectively and the remitter rates were 39.9% and 47.6%, respectively. Anxiety symptoms of depression improved for all COVI items in more than 80% of patients. Social functioning improved according to SDS in the domains work/school, social life and family life/home responsibilities in more than 90% of patients. Tolerability of agomelatine was rated as “very good/good” in 98.2% of the patients. ADRs were reported in 2.6% of patients. Conclusion: Agomelatine shows a broad effect on depressive symptoms, on depression-related anxiety symptoms and social functioning together with a good safety profile in daily practice.

Schlüsselwörter

Agomelatin - Depression - Angstsymptome - soziale Funktionsfähigkeit

Keywords

Agomelatine - depression - anxiety symptoms - psychosocial functioning
 

  • Literatur

  • 1 Baldwin DS, Anderson IM, Nutt DJ. et al. Evidence-based pharmacological treatment of anxiety disorders, post-traumatic stress disorder and obsessive-compulsive disorder: A revision of the 2005 guidelines from the British Association for Psychopharmacology. J Psychopharmacol 2014; 28: 403-439.
    CrossrefGoogle Scholar
  • 2 Courtet P, Olié E. Circadian dimension and severity of depression. Eur Neuropsychopharmacol 2012; 22: S476-S481.
    CrossrefGoogle Scholar
  • 3 D’Avanzato C, Martinez J, Attiullah N, Friedman M, Toba C, Boerescu DA, Zimmerman M. Anxiety symptoms among remitted depressed outpatients: Prevalence and association with quality of life and psychosocial functioning. J Affect Disord 2013; 151: 401-404.
    CrossrefGoogle Scholar
  • 4 De Berardis D, Marini S, Fornaro M, Srinivasan V. et al. The melatonergic system in mood and anxiety disorders and the role of agomelatine: implications for clinical practice. Int J Mol Sci 2013; 14: 12458-12483.
    CrossrefGoogle Scholar
  • 5 Demyttenaere K. Agomelatine in treating generalized anxiety disorder. Expert Opin Investig Drugs 2014; 23: 857-864.
    CrossrefGoogle Scholar
  • 6 Deutsche Gesellschaft für Psychiatrie, Psychotherapie und Nervenheilkunde (DGPPN); Bundesärztekammer (BÄK); Kassenärztliche Bundesvereinigung (KBV); Arbeitsgemeinschaft der Wissenschaftlichen Medizinischen Fachgesellschaften e. V. (AWMF) (Hrsg.). S3-Leitlinie/Nationale Versorgungs Leitlinie Unipolare Depression Kurzfassung. 2010
    Google Scholar
  • 7 Di Giannantonio M, Martinotti G. Anhedonia and major depression: the role of agomelatine. Eur Neuropsychopharmacol 2012; 22 (Suppl. 03) S505-510.
    CrossrefGoogle Scholar
  • 8 Fava M, Rush AJ, Alpert JE, Balasubramani GK, Wisniewski SR. et al. Difference in treatment outcome in outpatients with anxious versus nonanxious depression: a STAR*D report. Am J Psychiatry 2008; 165: 342-351.
    CrossrefGoogle Scholar
  • 9 Guaiana G, Gupta S, Chiodo D, Davies SJC. et al. Agomelatine versus other antidepressive agents for major depression. Cochrane Database Syst Rev 2013; 12: CD008851.
    Google Scholar
  • 10 Kasper S, Hajak G, Wulff K, Hoogendijk WJG, Montejo AL, Smeraldi E. et al. Efficacy of the novel antidepressant agomelatine on the circadian restactivity cycle and depressive and anxiety symptoms in patients with major depressive disorder: a randomized, double-blind comparison with sertraline. J Clin Psychiatry 2010; 71: 109-120.
    CrossrefGoogle Scholar
  • 11 Kelly K, Posternak M, Alpert JE. Toward achieving optimal response: understanding and managing antidepressant side effects. Dialogues Clin Neurosci 2008; 10: 409-418.
    Google Scholar
  • 12 Kennedy SH, Rizvi SJ. Agomelatine in the treatment of major depressive disorder: potential for clinical effectiveness. CNS Drugs 2010; 24: 479-499.
    CrossrefGoogle Scholar
  • 13 Laux G. Antidepressive Therapie mit Agomelatin in der Facharztpraxis. Ergebnisse der VIVALDIStudie. Psychopharmakotherapie 2011; 18: 18-26.
    Google Scholar
  • 14 Laux G, Huttner N. Agomelatin in der Depressionsbehandlung über 12 Monate. Follow-up der VIVALDI-Studie. Psychopharmakotherapie 2013; 20: 119-127.
    Google Scholar
  • 15 Lemke M, Barthel B. Treatment effect of agomelatine on depressive symptoms and patients compliance: results of the non-interventional study VITAL over 6 months. Eur Psych 2013 28 (Suppl. 01) 2267.
    Google Scholar
  • 16 Park SH, Ishino R. Liver injury associated with antidepressants. Current Drug Safety 2013; 08: 207-223.
    CrossrefGoogle Scholar
  • 17 Rapaport MH, Clary C, Fayyad R, Endicott J. Quality-of-life impairment in depressive and anxiety disorders. Am J Psychiatry 2005; 162: 1171-1178.
    CrossrefGoogle Scholar
  • 18 Sanderson K, Tilse E, Nicholson J, Oldenburg B, Graves N. Which presenteeism measures are more sensitive to depression and anxiety?. J Affect Disord 2007; 101: 65-74.
    CrossrefGoogle Scholar
  • 19 Sato S, Yeh TL. Challenges in treating patients with major depressive disorder: the impact of biological and social factors. CNS Drugs 2013; 27 (Suppl. 01) S5-10.
    CrossrefGoogle Scholar
  • 20 Schosser A, Serretti A, Souery D, Mendlewicz J, Zohar J. et al. European Group for the Study of Resistant Depression (GSRD) – where have we gone so far: review of clinical and genetic findings. Eur Neuropsychopharmacol 2012; 22: 453-468.
    CrossrefGoogle Scholar
  • 21 Stein DJ, Ahokas A, Albarran C, Olivier V, Allgulander C. Agomelatine prevents relapse in generalized anxiety disorder: a 6-month randomized, double-blind, placebo-controlled discontinuation study. J Clin Psychiatry 2012; 73: 1002-1008.
    CrossrefGoogle Scholar
  • 22 Stein DJ, Ahokas AA, de Bodinat C. Efficacy of agomelatine in generalized anxiety disorder: a randomized, double-blind, placebo-controlled study. J Clin Psychopharmacol 2008; 28: 561-566.
    CrossrefGoogle Scholar
  • 23 Stein DJ, Ahokas A, Márquez MS, Höschl C. et al. Agomelatine in generalized anxiety disorder: An active comparator and placebo-controlled study. J Clin Psychiatry 2014; 75: 362-368.
    CrossrefGoogle Scholar
  • 24 Stein DJ, Picarel-Blanchot F, Kennedy SH. Efficacy of the novel antidepressant agomelatine for anxiety symptoms in major depression. Hum Psychopharmacol 2013; 28: 151-159.
    CrossrefGoogle Scholar
  • 25 Taylor D, Sparshatt A, Varma S, Olofinjana O. Antidepressant efficacy of agomelatine: metaanalysis of published and unpublished studies. BMJ 2014; 348: g1888.
    CrossrefGoogle Scholar
  • 26 Taylor DJ, Walters HM, Vittengl JR, Krebaum S, Jarrett RB. Which depressive symptoms remain after response to cognitive therapy of depression and predict relapse and recurrence?. J Affect Disord 2010; 123: 181-187.
    CrossrefGoogle Scholar
  • 27 Wittchen HU, Jacobi F, Rehm J, Gustavsson A. et al. The size and burden of mental disorders and other disorders of the brain in Europe 2010. Eur Neuropsychopharmacol 2011; 21: 655-679.
    CrossrefGoogle Scholar
  • 28 Zajecka J, Schatzberg A, Stahl S, Shah A, Caputo A, Post A. Efficacy and safety of agomelatine in the treatment of major depressive disorder: a multicenter, randomized, double-blind, placebo-controlled trial. J Clin Psychopharmacol 2010; 30: 135-144.
    CrossrefGoogle Scholar
  • 29 Zimmerman M, McGlinchey JB, Posternak MA, Friedman M, Attiullah N, Boerescu D. How should remission from depression be defined? The depressed patient’s perspective. Am J Psychiatry 2006; 163: 148-150.
    CrossrefGoogle Scholar