Acute antimanic efficacy and safety of oxcarbazepine in an open trial with an on-off-on design

Bipolar Disord. 2002 Dec;4(6):412-7. doi: 10.1034/j.1399-5618.2002.02228.x.

Abstract

Rationale and objectives: Carbamazepine has shown reasonable antimanic properties, but its use has been limited because of enzyme-inducing effects. The keto-derivative oxcarbazepine (OXC) is very similar to carbamazepine, however, the metabolic pathway is different. OXC is not metabolized to the 10, 11-epoxide, which seems to be responsible for several undesirable side-effects of carbamazepine and furthermore OXC has less enzyme-inducing properties.

Methods: In this non-random open label study, patients were treated with OXC for 14 days, crossed over to no OXC for 7 days, and then crossed back over to OXC for the remaining 14 days. OXC was titrated to a final dose in a range of 900-2100 mg due to individual response. Treatment success was defined as a reduction of the original Young Mania Rating Scale (YMRS) score of more than 50% at the end of study period.

Results: Four of the 12 included patients (33%) met defined response criteria at the end of study period. Fifty percentage of the patients had to be prematurely excluded from the trial. The mean YMRS scores of the on-periods were obviously different from the off-period. Forty-two percentage of the patients experienced side-effects leading to premature discontinuation in two of 12 patients.

Conclusion: Antimanic activity of OXC was demonstrated in this pilot study only for patients with mild or moderate manic symptoms. Further studies are encouraged to clarify OXC's role as mood-stabilizer and assess whether it has a profile similar to that of carbamazepine.

Publication types

  • Clinical Trial
  • Comparative Study
  • Controlled Clinical Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Anticonvulsants / adverse effects
  • Anticonvulsants / therapeutic use*
  • Bipolar Disorder / drug therapy*
  • Carbamazepine / adverse effects
  • Carbamazepine / analogs & derivatives*
  • Carbamazepine / therapeutic use*
  • Cross-Over Studies
  • Dose-Response Relationship, Drug
  • Drug Administration Schedule
  • Female
  • Humans
  • Male
  • Middle Aged
  • Oxcarbazepine
  • Pilot Projects
  • Psychiatric Status Rating Scales
  • Psychometrics / methods
  • Time Factors
  • Treatment Outcome

Substances

  • Anticonvulsants
  • Carbamazepine
  • Oxcarbazepine