CARBAMAZEPINE VS HALOPERIDOL IN THE TREAT MENT OF THE ACUTE MANIC EPISODE - A CONTROLLED CLINICAL-TRIAL

Objective: To compare the efficiency of carbamazepine (CBZ) vs haloper idol (HLP) in the treatment of patients with a bipolar affective manic disorder. Method: we studied 20 inpatients with an acute manic disord er (DSM-III-R) between 18 and 55 years of age. Those who had received psychotropic drugs in the last two weeks, had a physical disorder or s howed dangerous and/or disruptive behavior, were excluded. At baseline , the patients were assessed with the Brief Psychiatric Rating Scale ( BPRS), the Bech and Rafaelsen Mania Assessment Scale (MAS) and the DiM ascio Extrapyramidal Symptoms Scale (DM), thereafter the patients were rated with these scales weekly during five weeks. The patients were r andomly assigned to one of two groups: CBZ or HLP. The daily drug dose s at the beginning of the study were three identical capsules, each co ntaining 200 mg of CBZ or 5 mg of HLP. If the patient showed a decreas e of < 25% in the weekly MAS and BPRS scores, the dose was increased b y one capsule per day until a dose of 8 capsules was reached or the th erapeutic response was obtained (an improvement in MAS and BPRS scores > 25%). Results: 75% of the subjects were females and the overall mea n age was 35.3 +/- 11.1 years. At the beginning of the study, the seve rity of the symptoms was similar in both groups (MAS: CBZ 30.7 +/- 3.3 vs HLP 27.3 +/- 7.1; BPRS: CBZ 24.2 +/- 8 vs HLP 20.45 +/- 6.8). The one factor ANOVA for repeated measures, showed that the therapeutic re sponse was similar for both groups in the MAS [F(1,13) = 1.02, p = n.s .], as in the BPRS (F < 1). Improvement throughout time, both in the M AS [F(5,5) = 29.98, p < 0.001], as in the BPRS [F(5,5) = 25.42, p < 0. 001] were significant. Changes were observed from the first week of tr eatment (MAS: CBZ 23% vs HLP 30% of improvement; BPRS: CBZ 30% vs HLP 2 3 % of improvement). In contrast, the DM scores showed differences b etween groups [F(1,13) = 63.16, p < 0.0011; also, the effect of time w as significant [F(5,5) = 4.71, p < 0.001]. The final DM scores were: C BZ 0.17 +/- 0.41 vs HLP 4.6 +/- 2.5). Besides, a higher frequency of p sychomotor agitation was observed in the CBZ group (50%) than in the H LP group (10%). Conclusions: data shows a similar antimanic effect of CBZ and HLP. This suggests that CBZ might be a first choice treatment in the management of acute manic episodes without significant psychomo tor agitation.