ABSTRACT
In a double-blind, 4-week, prospective, randomized multicenter (17 centers) study we checked on the efficacy, tolerability and safety of moclobemide (300-600 mg/d) compared to imipramine (100-200 mg/d) in parallel groups of patients with a Major Depressive Episode (DSM III). The mean % reduction of the HAMD at the end of treatment was 51.7 in the moclobemide group and 52.1 in the imipramine group. The percentage of patients in whom efficacy was globally judged as "good" or "very good" was 62% in the moclobemide group and 60% in the imipramine group. There was no statistically significant difference in the efficacy in both groups but in some factors there was a trend for a better amelioration favoring moclobemide. The final overall physician's judgement of tolerability was "good" or "very good" in 83% of moclobemide patients and in 74% of imipramine patients. Adverse events were reported or observed in 56% of moclobemide patients and in 69% of imipramine patients. The number of mild, moderate and severe adverse events was higher in the imipramine group with a total of 286 versus 189. There was a statistically high significant difference considering the tolerability favoring moclobemide again. In this project the basic goal to find a substance with at least the same efficacy but a much better tolerability for sure got fulfilled.
Subject(s)
Benzamides/therapeutic use , Depressive Disorder/drug therapy , Imipramine/therapeutic use , Monoamine Oxidase Inhibitors/therapeutic use , Adolescent , Adult , Aged , Aged, 80 and over , Austria , Benzamides/adverse effects , Depressive Disorder/psychology , Double-Blind Method , Female , Humans , Imipramine/adverse effects , Male , Middle Aged , Moclobemide , Prospective Studies , Psychiatric Status Rating ScalesABSTRACT
The antidepressant efficacy, tolerability, and safety of moclobemide, a reversible, monoamine oxidase-A inhibitor, were compared with those of imipramine in parallel groups of patients with a major depressive episode, in a 4-week, multicentre (17 centres), randomised study. A total of 381 patients were randomly allocated to either treatment; they were not required to avoid tyramine-rich foods. Drop-out rates were comparable in both groups at about 17%. Judged primarily on the HRSD, no significant differences in efficacy were observed between the groups, but the number of patients presenting with adverse events, as well as the total number of adverse events, was greater with imipramine. Cardiovascular tolerability was satisfactory and physical examination, body weight, and laboratory values were essentially unaffected in both groups.
Subject(s)
Adjustment Disorders/drug therapy , Benzamides/therapeutic use , Bipolar Disorder/drug therapy , Depressive Disorder/drug therapy , Imipramine/therapeutic use , Monoamine Oxidase Inhibitors/therapeutic use , Adult , Aged , Aged, 80 and over , Austria , Benzamides/adverse effects , Double-Blind Method , Female , Humans , Imipramine/adverse effects , Male , Middle Aged , Moclobemide , Monoamine Oxidase Inhibitors/adverse effects , Multicenter Studies as Topic , Prospective Studies , Psychiatric Status Rating Scales , Randomized Controlled Trials as TopicABSTRACT
Socio-psychiatric relevant data were excerpted from our own records of patients whose cases had been followed up for years and from 67 questionnaires on suicide prophylaxis established by the "Work Group for Preventive and Social Medicine" (Arbeitskreis für Vorsorge- und Sozialmedizin). The following items were dealt with: age and sex distribution, social status, habitation structure, kind of suicide attempt and, particularly, its diagnostic category. The analysis and evaluation of the data formed the basis for an attempt to work out a "new group" which would reach further than the classical diagnostic groups and which has not yet been reported in the literature. The new group is distinguished by loss of cognitive and emotional stability. This socio-psychiatric study closes with a discussion of the therapeutic aspects of prevention and intervention, the significance of which is emphasized by the high rate of repeated suicide attempts.
Subject(s)
Suicide Prevention , Adolescent , Adult , Aged , Child , Crisis Intervention , Divorce , Family Characteristics , Female , Housing , Humans , Male , Middle Aged , Suicide/psychology , Suicide, AttemptedABSTRACT
Fifty patients suffering principally from neurotic and psychosomatic disturbances were treated for 6 months with an average of 30 mg clobazam (Frisium) per day. For documentation of the efficacy and tolerance a set of assessment scales and procedures from the ECDEU system (Early Clinical Drug Evaluation Unit) was compiled. The results showed unanimously the anxiolytic efficacy and good tolerance of clobaza. After the second week of treatment there was a significant reduction in the anxiety symptoms in the judgement of the doctor and patient (p less than 0.01). Parallel to the reduction of anxiety symptoms the general condition also improved. The good tolerance of clobazam was shown in the overall clinical assessment and in the recording of specific side effects, which could never be called severe in any case. Moreover, there were no suggestions of changes in tolerance of of dependency.