title: Therapeutic drug monitoring of zuclopenthixol in a double-blind placebo-controlled discontinuation study in adults with intellectual disabilities and aggressive behaviour.
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.
authors.affiliation: Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, -Rostock, Germany.
authors.forename: V
authors.initials: V
authors.lastname: Schwarz
authors.affiliation: Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, -Rostock, Germany.
authors.forename: O
authors.initials: O
authors.lastname: Reis
authors.affiliation: Bayer Vital GmbH, Leverkusen, Germany.
authors.forename: T
authors.initials: T
authors.lastname: Glaser
authors.affiliation: Clinic of Psychiatry and Psychotherapy, University of Rostock, Rostock, Germany.
authors.forename: J
authors.initials: J
authors.lastname: Thome
authors.affiliation: Department of Psychiatry and Psychotherapy, University Medical Centre of Mainz, Mainz, Germany.
authors.forename: C
authors.initials: C
authors.lastname: Hiemke
authors.affiliation: Clinic for Child and Adolescence Psychiatry, Neurology, Psychosomatics and Psychotherapy, University of Rostock, -Rostock, Germany.
authors.forename: F
authors.initials: F
authors.lastname: Haessler
mesh_terms: D000293:Adolescent; D000328:Adult; D000374:Aggression / Q000187:drug effects*; D014150:Antipsychotic Agents / Q000494:pharmacology / Q000627:therapeutic use; D003006:Clopenthixol / Q000494:pharmacology* / Q000627:therapeutic use*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D016903:Drug Monitoring; D005260:Female; D006801:Humans; D008607:Intellectual Disability / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D013223:Statistics as Topic; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D014150:Antipsychotic Agents; D003006:Clopenthixol