title: Efficacy and safety of combination of risperidone and haloperidol with divalproate in patients with acute mania.
abstract: OBJECTIVE
  The current study evaluated the efficacy and safety of risperidone and haloperidol as an adjunctive agent in combination with divalproate in patients with an episode of acute mania.
  
  
  METHODS
  This 6-week randomized, single-blind study was conducted in psychiatric wards of a mental hospital. A total of 41 patients were randomly assigned to the risperidone (risperidone plus divalproate) or haloperidol groups (haloperidol plus divalproate). Efficacy was assessed by changes in symptom rating scales [Young Mania Rating Scale (YMRS), Brief Psychiatric Rating Scale (BPRS), and Clinical Global Impression (CGI) scores]. Safety and tolerability were assessed by monitoring the Extrapyramidal Symptom Rating Scale (ESRS) and Hamilton Rating Scale for depression.
  
  
  RESULTS
  Mean doses at baseline, and at weeks 4 and 6 were 3.77, 4.95 and 5.00 mg/day of risperidone and 5.89, 9.95 and 8.58 mg/day of haloperidol, respectively. Risperidone was shown to have significant anti-manic effects which was observed as early as week 1, following start of treatment. The BPRS scores were in favor of risperidone at week 2. Patients receiving risperidone exhibited significant greater global improvement on the CGI, as early as week 2 and over the entire treatment period, than haloperidol after 4 weeks of treatment. The ESRS at endpoint were significantly higher in the haloperidol patients.
  
  
  CONCLUSIONS
  Risperidone plus divalproate was more efficacious than haloperidol plus divalproate for treatment of acute mania, and was well tolerated due to its evidence showing rapid anti-manic action, effective and sustained control of manic and psychotic symptoms and a favorable safety and tolerability profile in acute mania.
authors.affiliation: Department of Geriatric Psychiatry, Jianan Mental Hospital, Taiwan. d88904@mail.cnpc.gov.tw
authors.forename: Wen-Chen
authors.initials: WC
authors.lastname: Ouyang
authors.forename: Mei-Chi
authors.initials: MC
authors.lastname: Hsu
authors.forename: I-Ning
authors.initials: IN
authors.lastname: Yeh
authors.forename: Chien-Cheng
authors.initials: CC
authors.lastname: Kuo
mesh_terms: D000208:Acute Disease; D000293:Adolescent; D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014150:Antipsychotic Agents / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D001835:Body Weight / Q000187:drug effects; D002648:Child; D004359:Drug Therapy, Combination; D004409:Dyskinesia, Drug-Induced / Q000453:epidemiology; D005260:Female; D006220:Haloperidol / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D006778:Hospitals, Psychiatric; D006801:Humans; D008297:Male; D008875:Middle Aged; D011569:Psychiatric Status Rating Scales; D018967:Risperidone / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D055815:Young Adult
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents; D014635:Valproic Acid; D006220:Haloperidol; D018967:Risperidone