Pharmacopsychiatry 2014; 47(01): 29-32
DOI: 10.1055/s-0033-1361115
Original Paper
© Georg Thieme Verlag KG Stuttgart · New York

Therapeutic Drug Monitoring of Zuclopenthixol in a Double-Blind Placebo-Controlled Discontinuation Study in Adults with Intellectual Disabilities and Aggressive Behaviour

V. Schwarz
1   Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, ­Rostock, Germany
,
O. Reis
1   Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, ­Rostock, Germany
,
T. Glaser
2   Bayer Vital GmbH, Leverkusen, Germany
,
J. Thome
3   Clinic of Psychiatry and Psychotherapy, University of Rostock, Rostock, Germany
,
C. Hiemke
4   Department of Psychiatry and Psychotherapy, University Medical Centre of Mainz, Mainz, Germany
,
F. Haessler
1   Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, ­Rostock, Germany
› Author Affiliations
Further Information

Publication History

received 19 July 2013
revised 28 October 2013

accepted 31 October 2013

Publication Date:
04 December 2013 (online)

Abstract

The trial was a double-blind, placebo-controlled comparison with a discontinuation design. 49 mentally retarded patients with aggressive behaviour were treated with zuclopenthixol at a dose of 2–20 mg/d. At each visit the clinical effect was evaluated. Correlations between dose, serum concentration, and efficacy measures were calculated. The mean dose was 10.0 mg/day (±5.17); the mean serum concentration 4.19 ng/mL (±3.16). Associations of dosage, serum concentration and clinical efficiency did not result in coherent patterns. Correlations with clinical efficiency measures appeared to be contradictory for dosage and serum concentrations, respectively. As no consistent associations between dosage, serum concentration, and clinical efficiency measures were found, different hypotheses explaining the results are discussed.

 
  • References

  • 1 Cooper SA, Smiley E, Morrison J et al. Mental ill-health in adults with intellectual disabilities: prevalence and associated factors. Br J Psychiatry 2007; 190: 27-35
  • 2 Santosh PJ, Baird G. Psychopharmacotherapy in children and adults with intellectual disability. The Lancet 1999; 354: 233-242
  • 3 Haessler F, Glaser T, Beneke M et al. Zuclopenthixol in adults with intellectual disabilities and aggressive behaviours: Discontinuation study. Br J Psychiatry 2007; 190: 447-448
  • 4 Haessler F, Glaser T, Pap AF et al. A double-blind placebo-controlled discontinuation study of zuclopenthixol for the treatment of aggressive disruptive behaviours in adults with mental retardation – secondary parameter analyses. Pharmacopsychiatry 2008; 41: 232-239
  • 5 Davies SJC, Westin AA, Castberg I et al Characterisation of zuclopenthixol metabolism by in vitro and therapeutic drug monitoring studies. Acta Psychiatr Scand 2010; 122: 444-453
  • 6 Hiemke C, Baumann P, Bergemann N et al AGNP consensus guidelines for therapeutic drug monitoring in psychiatry: Update 2011. Pharmacopsychiatry 2011; 44: 195-235
  • 7 Jaanson P, Marandi T, Kiivet R-A et al Maintenance therapy with zuclopenthixol decanoate: associations between plasma concentrations, neurological side effects and CYP2D6 genotype. Psychopharmacology 2002; 162: 67-73
  • 8 Nygaard H, Bakke K, Brudvike E et al. Dosing of neuroleptics in elderly demented patients with aggressive and agitated behaviour: a double-blind study with zuclopenthixol. In: Curr Med Res Opin 1994; 13: S222-S232
  • 9 Gex-Fabry M, Balant-Gorgia A, Balant L. Therapeutic drug monitoring databases for postmarketing surveillance of drug-drug interactions: evaluation of a paired approach for psychotropic medication. In: Ther Drug Monit 1997; 19: S1-S10
  • 10 Tyrer P, Oliver-Africano PC, Ahmed Z et al Risperidone, haloperidol, and placebo in the treatment of aggressive challenging behaviour in patients with intellectual disability: a randomised controlled trial. Lancet 2008; 371: 57-63