femoxetine and Depressive-Disorder

Fifty-two patients with depressive illness characterized by four symptoms (periodical course, psychomotor retardation, diurnal variation, unrealistic self-depreciation) and a score of at least 18 on the Hamilton Depression Scale 1-17 (HDS) were allocated to a double-blind randomized study with femoxetine and imipramine. Patients were diagnosed according to RDC and further classified according to the Newcastle-II index. During the six weeks of treatment, efficacy was evaluated by means of HDS and a global evaluation. Side-effect symptoms were recorded on a check-list by questioning. After six weeks of treatment with femoxetine or imipramine (recommended daily standard dosages are 600 mg femoxetine and 150 mg imipramine (b.i.d.); in the present study, dosages were flexible and could be adjusted according to effect/side-effects) evaluation of efficacy based on HDS, a six-item subscale, groups of HDS items as well as single items showed no statistically significant differences between the treatment groups except with regard to the factor for sleep disturbances in the HDS, where greatest reduction was seen in the femoxetine group. No statistically significant differences regarding side-effect profile were seen. However, in the imipramine group, higher frequencies of such moderate to severe symptoms as dry mouth, constipation and urination difficulties were observed (the greatest difference was seen for dry mouth, p 0.1, while p-values for the remaining two symptoms were greater than 0.1). Moreover, based on the patients' own opinion on side-effects, femoxetine seemed to be better tolerated. One patient took an overdosage of approx. 26 g femoxetine; half of the intake was removed by gastric emptying at the hospital.(ABSTRACT TRUNCATED AT 250 WORDS)

Topics: Adolescent; Adult; Antidepressive Agents; Clinical Trials as Topic; Depressive Disorder; Double-Blind Method; Female; Half-Life; Humans; Imipramine; Male; Middle Aged; Piperidines; Psychiatric Status Rating Scales; Random Allocation; Time Factors

Patients with a depressive illness with 4 major symptoms of depression and a score of at least 17 on the Hamilton Depression Scale (1-17) (HDS) were allocated to a randomized double-blind group comparative study in general practice. After retrospective analysis, all 81 patients except one were characterized as suffering from a 'Definite Major Depressive Disorder', as defined by Spitzer et al. (1978). After 6 weeks of treatment with a daily dosage of 600 mg femoxetine or 150 mg amitriptyline, no statistically significant differences between the 2 treatment groups were observed, either when using the HDS or the clinical global assessment scale. Confidence limits of 95% for differences between therapeutic effect showed a non-significant tendency in favour of amitriptyline. During treatment, there were statistically significant differences in the reduction of HDS score between the 2 treatments in week 2. These differences were the result of amitriptyline's significantly greater effect on the 3 sleep items at week 2, as indicated by the results of single item analysis. Drop out rates due to side effects were between 14-15% in both treatment groups. Of the patients treated with femoxetine, 38% experienced no side effects, compared to 14% of patients treated with amitriptyline. Nausea was the side effect most commonly reported by patients treated with femoxetine, whereas a significantly greater frequency of anticholinergic side effects was recorded during treatment with amitriptyline (P less than 0.05). Unlike amitriptyline, femoxetine did not increase body weight. Treatment with the active drug was continued after the trial period in 14 and 18 patients in the femoxetine and amitriptyline groups respectively.

Topics: Adolescent; Adult; Aged; Amitriptyline; Antidepressive Agents; Body Weight; Depressive Disorder; Double-Blind Method; Female; Humans; Male; Middle Aged; Piperidines; Random Allocation; Serotonin

The antidepressant and biochemical effects of femoxetine, a selective serotonin uptake inhibitor, and desipramine, a selective nor-adrenaline uptake inhibitor, have been compared in a double-blind study in 42 outpatients with depressive illness. The patients were allocated at random to treatment with either 600 mg femoxetine or 150 mg desipramine daily for 6 weeks. The total depression score showed a significant decrease in both groups, indicating an overall improvement in depressive symptoms. The patients treated with femoxetine reported significantly less severe anticholinergic effects during the whole treatment period than the desipramine patients. Both drugs, decreased the level of 5-HIAA in CSF, whereas no consistent changes were found in the MHPG and HVA levels. The pretreatment level of the metabolites had no predictive value for the outcome of the treatment with either drug. No significant correlation was found between therapeutic effect and the plasma concentration of the active compounds.

Topics: Adult; Aged; Antidepressive Agents; Depressive Disorder; Desipramine; Double-Blind Method; Female; Glycols; Homovanillic Acid; Humans; Hydroxyindoleacetic Acid; Male; Methoxyhydroxyphenylglycol; Middle Aged; Phenylacetates; Piperidines

The new selective serotonin (5-HT)-uptake inhibitor femoxetine was compared with amitriptyline in a double-blind clinical trial comprising 77 depressed patients. The depressive symptoms were evaluated with the Hamilton rating scale, and a global clinical evaluation. Both drugs showed an antidepressive effect and no significant differences were found. Femoxetine induced a significantly lower frequency of dry mouth and blurred vision; this difference is presumably due to the weak anticholinergic effect of this substance. A small but significant weight loss was observed in the femoxetine group but not in the amitriptyline group.

Topics: Amitriptyline; Antidepressive Agents; Clinical Trials as Topic; Depressive Disorder; Double-Blind Method; Female; Humans; Male; Middle Aged; Piperidines; Psychiatric Status Rating Scales