title: Risperidone alone versus risperidone plus valproate in the treatment of patients with schizophrenia and hostility.
abstract: The objective of the study was to compare the antiaggressive efficacy of risperidone monotherapy versus risperidone plus valproate in patients with schizophrenia. This was an 8-week open-label randomized parallel group clinical trial in hospitalized adults diagnosed with schizophrenia and with hostile behavior. Patients were randomly assigned to receive risperidone alone (n=16) or risperidone plus valproate (n=17). To minimize bias, raters were blinded to the assigned treatment arm. Outcome measures included the Positive and Negative Syndrome Scale (PANSS), Buss-Durkee Hostility Inventory (BDHI), Barratt Impulsiveness Scale (BIS), Nurses Observation Scale for Inpatient Evaluation (NOSIE), and the Overt Aggression Scale (OAS). Although significantly fewer patients randomized to monotherapy completed the study (chi(2)=8.62, d.f.=1, P=0.003), no significant differences between monotherapy or combination treatment were observed in change of the BDHI, BIS, NOSIE, PANSS total scores, OAS measures of aggressive behavior or the hostility item of the PANSS. In conclusion, although patients receiving combination treatment were more likely to complete the study, we were unable to detect a meaningful advantage for combination therapy as measured by rating scales.
authors.affiliation: Nathan S Kline Institute for Psychiatric Research, Orangeburg, New York 10962, USA. citrome@nki.rfmh.org
authors.forename: Leslie
authors.initials: L
authors.lastname: Citrome
authors.forename: Constance B
authors.initials: CB
authors.lastname: Shope
authors.forename: Karen A
authors.initials: KA
authors.lastname: Nolan
authors.forename: Pal
authors.initials: P
authors.lastname: Czobor
authors.forename: Jan
authors.initials: J
authors.lastname: Volavka
mesh_terms: D000328:Adult; D000374:Aggression / Q000187:drug effects / Q000523:psychology; D000927:Anticonvulsants / Q000009:adverse effects / Q000627:therapeutic use; D014150:Antipsychotic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003967:Diarrhea / Q000139:chemically induced; D004359:Drug Therapy, Combination; D005260:Female; D006791:Hostility; D006801:Humans; D016014:Linear Models; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000009:adverse effects / Q000627:therapeutic use*; D012559:Schizophrenia / Q000175:diagnosis / Q000188:drug therapy*; D013608:Tablets, Enteric-Coated; D016896:Treatment Outcome; D014635:Valproic Acid / Q000009:adverse effects / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced
chemical_list: D000927:Anticonvulsants; D014150:Antipsychotic Agents; D013608:Tablets, Enteric-Coated; D014635:Valproic Acid; D018967:Risperidone