Twenty patients who had become accustomed to a stable oral carbamazepine dose participated in an open, randomized, two-centre, cross-over study, in which ordinary tablets and Divitabs (a new sustained release preparation) were compared. Pharmacokinetic parameters, seizure control, effects on the behavioral state, and tolerability were considered. A smaller Area Under the Curve (AUC) during the Divitabs period was the only pharmacokinetic parameter with a significant difference (p less than 0.05). However, all patients with peak/trough carbamazepine serum level ratios of at least 1.30 after the intake of the normal tablet-form (n = 9) showed a smaller peak/trough ratio during the Divitabs period. No remarkable differences were found between the normal carbamazepine preparation and Divitabs regarding seizure frequency and tolerability. The behavioral state improved in four patients during the Divitabs period, whereas no enhancement was noticed during the normal-tablet period in any of the subjects. Although this study produced no evidence that carbamazepine Divitabs were at all advantageous for the trial population in general, some of the pharmacokinetic results suggest that a subgroup of the patients would benefit from changing from the normal tablet-form to Divitabs. However, even in this subgroup, the usage of Divitabs was not shown to result in obvious clinical benefits.
Patients treated with carbamazepine (Tegretol | sometimes suffer from cognitive sideeffects that may be caused by high serum levels and/or large fluctuations in serum levels of carbamazepine [1]. Cognitive side-effects might occur less frequently when Divitabs | a slowrelease formulation of carbamazepine, are used.In a single-blind cross-over study, Aldenkamp et al. found that patients performed better on psychological tests of memory and accuracy of visual information processing during the Divitabs | period than during the 'normal formulation' period [2]. In an open, randomized, crossover study, in which ordinary carbamazepine tablets and Divitabs | were compared with regard to pharmacokinetic parameters, seizure control, effects on the behavioural state and general tolerance in 20 patients, Divitabs | were not generally found to be advantageous for our trial population [Nijdam JR, Doorschot CH, Van Bavel LP, Loonen AJM, unpublished observations]. However, in all patients who had a peak/trough ratio (Cmax/Cmin) of carbamazepine serum concentrations exceedings 1.30 during the 'normal formulation' period, these ratios were lower after the intake of Divitabs | suggesting that a subgroup of our patients might benefit from Divitabs | Therefore, we embarked on a double-blind randomized cross-over trial to compare the conventional formulation of carbamazepine to carbamazepine Divitabs | with regard to pharmacokinetic parameters and cerebral effects. This was carried out in patients whose Cmax/Cmin of carbamazepine was greater than 1.30 and whose trough level (Cml,) exceeded 5.0 mg/1 during a baseline period on carbamazepine 'normal formulation' tablets of four weeks. As
Several studies have demonstrated that psychomotor retardation is an important sign of the major depressive episode, both from a diagnostic point of view and as a predictor of treatment outcome. However, it is uncertain to what extent psychomotor retardation is specific for the major depressive episode. A heterogeneous group of psychiatric patients (n=26) was studied using a rating scale developed specifically to assess psychomotor retardation (RRS). The 13 patients suffering from a major depressive episode had a significantly higher RRS score than patients with another diagnosis. Furthermore, in the depressive subjects the severity of the depression (measured by means of Hamilton's depression rating scale) appeared to correlate with the severity of the psychomotor retardation. Cognitive features of psychomotor retardation were mainly responsible for the more severe psychomotor retardation in the depressive patients. Surprisingly. Hamilton's depression scale which was used in this study does not pay much attention to these aspects.
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