A double-blind placebo-controlled discontinuation study of zuclopenthixol for the treatment of aggressive disruptive behaviours in adults with mental retardation - secondary parameter analyses.
BACKGROUND
Earlier studies showed risperidone to be effective in the treatment of aggression and self-injurious behaviour in adults with mental retardation but also having adverse side effects. This study was conducted to evaluate the effects of zuclopenthixol withdrawal.


METHODS
After open treatment with zuclopenthixol (n=49) responders were randomly assigned to continue (n=19) or discontinue (n=20) zuclopenthixol treatment during a 12-week double-blind, placebo-controlled period. Effects were measured using the Disability Assessment Schedule (DAS), improvement on the Clinical Global Impression Scale (CGI-I), and the Nurse's Observation Scale for Inpatient Evaluation (NOSIE).


RESULTS
Ten patients (20%) discontinued the study due to insufficient therapeutic effect or adverse events in the open period.


RESULTS
The superiority of zuclopenthixol over placebo among all randomized patients was supported not only by primary efficacy measure but also by the comparisons of mean scores of all secondary efficacy measures tested in a step-down-procedure (DAS, p<0.001; CGI-I, p<0.002, NOSIE, p<0.005).


RESULTS
In both groups, one patient discontinued (5%) for adverse events. Adverse events were generally mild or moderate in severity.


CONCLUSIONS
Zuclopenthixol proved to be safe and effective to keep a low rate of aggressive behaviour in adults with mental retardation.
Hässler
F
F
Clinic for Child and Adolescent Psychiatry, University of Rostock, Rostock, Germany. frank.haessler@med.uni-rostock.de
Glaser
T
T
Pap
A F
AF
Beneke
M
M
Diefenbacher
A
A
Reis
O
O
D000293:Adolescent; D000328:Adult; D000374:Aggression; D014150:Antipsychotic Agents / Q000009:adverse effects* / Q000627:therapeutic use*; D019958:Attention Deficit and Disruptive Behavior Disorders / Q000188:drug therapy* / Q000523:psychology*; D003006:Clopenthixol / Q000009:adverse effects* / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008607:Intellectual Disability / Q000523:psychology*; D007361:Intelligence Tests; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D013375:Substance Withdrawal Syndrome / Q000523:psychology*; D055815:Young Adult
D014150:Antipsychotic Agents; D003006:Clopenthixol