title: Combination treatment with aripiprazole and valproic acid for acute mania: an 8-week, single-blind, randomized controlled trial.
abstract: OBJECTIVE
  Despite the fact that combination treatment for patients with acute bipolar is prevalent in clinical practice, the outcomes of adjunct treatment with aripiprazole and a mood stabilizer have rarely been reported. The aim of this single-blind, randomized, controlled trial was to investigate treatment efficacy and safety of aripiprazole as an adjunct to valproic acid (Ari+Val), compared with haloperidol plus valproic acid (Hal+Val), in acute manic patients.
  
  
  METHODS
  Treatment efficacy was prospectively assessed for 8 weeks in 42 patients with acute mania using the Young Mania Rating Scale and the Clinical Global Impression-Severity of illness scale. Emergent adverse events were assessed by the Drug-Induced Extrapyramidal Symptoms Scale and the Liverpool University Neuroleptic Side Effect Rating Scale.
  
  
  RESULTS
  Both Ari+Val and Hal+Val produced a high rate of response (85.7% and 92.9%, respectively) and remission (82.1% and 85.7%, respectively) after the 8-week trial. Changes in the Young Mania Rating Scale and the Clinical Global Impression-Severity of illness scale over the study period and time to remission and response were not significantly different between the 2 groups. Patients treated with Ari+Val showed significantly fewer extrapyramidal adverse events than those treated with Hal+Val (t = -2.048, F = 40, P = 0.048). However, significant weight gain was more prevalent in the Ari+Val group than the Hal+Val group (t = 2.055, F = 40, P = 0.046).
  
  
  CONCLUSIONS
  Our findings suggest that both combination strategies with Ari+Val and Hal+Val are beneficial for acute manic episode. Although patients receiving Ari+Val showed fewer extrapyramidal symptoms than those taking Hal+Val, careful consideration of adverse events such as weight gain and sedation is warranted.
authors.affiliation: Department of Psychiatry, Korea University Guro Hospital, Korea University College of Medicine, Seoul, Korea.
authors.forename: Hyun-Ghang
authors.initials: HG
authors.lastname: Jeong
authors.forename: Moon-Soo
authors.initials: MS
authors.lastname: Lee
authors.forename: Young-Hoon
authors.initials: YH
authors.lastname: Ko
authors.forename: Changsu
authors.initials: C
authors.lastname: Han
authors.forename: In-Kwa
authors.initials: IK
authors.lastname: Jung
mesh_terms: D000208:Acute Disease; D000328:Adult; D018692:Antimanic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D014150:Antipsychotic Agents / Q000008:administration & dosage* / Q000009:adverse effects; D000068180:Aripiprazole; D001714:Bipolar Disorder / Q000188:drug therapy* / Q000523:psychology; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010879:Piperazines / Q000008:administration & dosage* / Q000009:adverse effects; D011446:Prospective Studies; D015363:Quinolones / Q000008:administration & dosage* / Q000009:adverse effects; D016037:Single-Blind Method; D016896:Treatment Outcome; D014635:Valproic Acid / Q000008:administration & dosage* / Q000009:adverse effects; D015430:Weight Gain / Q000187:drug effects; D055815:Young Adult
chemical_list: D018692:Antimanic Agents; D014150:Antipsychotic Agents; D010879:Piperazines; D015363:Quinolones; D014635:Valproic Acid; D000068180:Aripiprazole