Comparison of clinical efficacy of carbamazepine and haloperidol as adjuncts to lithium in patients with acute manic phase: A double-blind clinical trial

Abstract

There is abundant evidence that the efficacy of the carbamazepine-lithium combination in acute manic episodes is comparable to that of other custom medications (e.g., a haloperidol-lithium combination). The aim of the current investigation was to compare the clinical efficacy and side effects of lithium combined with carbamazepine versus lithium combined with haloperidol and biperiden in patients with bipolar disorder. In the present study, 24 patients in an acute manic phase were randomly assigned to receive either lithium-carbamazepine (Li-CBZ) or lithium-haloperidol (Li-Hal) combinations for 8 weeks. Clinical (including ESRS, MRS, CBZ side effect profile, and HAM-D) and laboratory measurements were regularly performed on all patients. Both therapeutic regimens were effective in alleviating manic symptoms, whether psychotic features were present or not (p<.001). However, there was a faster response to treatment for the Li-CBZ group compared to the Li-Hal group, as revealed by a lower mean MRS score on day 14 in the former group (p=.018). HAM-D scores revealed significantly better outcomes for the Li-CBZ group. A higher mean HAM-D score on day 56, as well as a higher mean alteration in HAM-D scores throughout the study period, were noted in the Li-Hal group (p=.008 and p=.011, respectively). Dropouts in the Li-Hal group were considerable due to noncompliance resulting from neuroleptic-induced side effects (depressive and extrapyramidal). Similarly, several subjects in the Li-CBZ group had to end the study prematurely as a result of developing side effects for which drug discontinuation is indicated. It may be prudent to reevaluate neuroleptic medications in manic patients, specifically for long-term management.