A controlled multicenter clinical study of citalopram and placebo in elderly depressed patients with and without concomitant dementia.

A total of 149 patients in 7 centers in Denmark, Norway and Sweden entered a 6-week double-blind trial intended to assess the antidepressant effect and safety of citalopram vs placebo in depressed elderly patients (65 years of age or older) who might also suffer from somatic disorders and/or senile dementia. Results of ratings on the Hamilton Rating Scale for Depression, the Montgomery-Asberg Depression Rating Scale and the Clinical Global Impression Scale provided consistent evidence that the citalopram-treated patients improved more than the placebo-treated patients. Results of ratings on the Gottfries-Bråne-Steen dementia rating scale indicated that both cognitive and emotional functioning improved significantly more in the citalopram-treated subgroup of patients with dementia than in the placebo-treated subgroup.

Primary care treatment of depression in the elderly: a double-blind, multi-centre study of flupenthixol ('Fluanxol') and sustained-release amitriptyline.

A multi-centre general practice study was carried out to compare flupenthixol and a sustained-release preparation of amitriptyline in the primary care treatment of depression in the elderly. Fifty-one clinically depressed patients, aged 65 years or over, were allocated at random to one of the two treatment groups in this 4-week double-blind, double-dummy study. On entry, patients received either a 0.5 mg flupenthixol tablet in the morning and a placebo capsule at night (25 patients) or a 25 mg sustained-release amitriptyline capsule at night and a placebo tablet in the morning (26 patients), but at the end of the first or second weeks the dosage could be doubled according to the assessed clinical need. Fourteen patients in each treatment group had their dosages doubled. Patient assessment was undertaken on study entry and after 1, 2 and 4 weeks of treatment using a 0 to 3 scale global assessment and the Montgomery Asberg Depression Rating Scale; side-effects were recorded on the UKU Scale. After 4-weeks' treatment, over 80% of patients in each group had improved and in the flupenthixol group there was additionally a noticeable and highly significant reduction in symptom severity after only 1 week of treatment. Patients treated with flupenthixol had fewer and milder side-effects.

A double-blind comparison of citalopram (Lu 10-171) and amitriptyline in depressed patients.

In a controlled, clinical, multicentre trial comprising a total of 43 patients (17 men and 26 women) citalopram was compared double-blindly with amitriptyline. Nineteen patients of each group were classified as endogeneously depressed, whereas four patients of the citalopram group and one of the amitriptyline group were classified as non-endogenously depressed. The patients were seriously ill with a high frequency of previous depressive episodes and of mental disorders among their closest relatives. Thirteen of the patients in either group had received antidepressants without satisfactory effect before entry into the trial. Each patient was treated for a period of at least 3 weeks with daily citalopram doses of 30-60 mg or daily amitriptyline doses of 75-225 mg. A statistically significant reduction of MADRS scores (total scores as well as each of the 10 individual items) was recorded in both groups. The only difference between the groups was a trend towards a better effect on sleep disturbances in the amitriptyline group. Side-effects were recorded more frequently in the amitriptyline group than in the citalopram group, global assessment of side effects being significantly different in favour of citalopram. It is concluded that citalopram is an effective and safe drug in the treatment of endogenous depression - probably as efficacious as amitriptyline, but with fewer side effects.

Citalopram--a specific 5-HT-reuptake inhibitor--as an antidepressant drug: a phase II multicentre trail.

1. Twenty-nine inpatients with a long history of rather severe, affective psychosis were admitted for a 4 weeks treatment with citalopram, a very specific 5-Ht-reuptake inhibitor. 2. Twenty-six patients (15 men and 11 women) completed the study and among these 15 had been depressed for more than 10 years and 19 showed an entry total score of more than 25 points on the Hamilton Rating Scale for Depression (17 items). 3. When treated with a dose of 40-60 mg once daily, approximately one third of the patients showed a marked response and another third a moderate response to treatment. Fifteen of the patients showed a marked or moderate response already within the first two weeks of treatment. 4. Only a few and transient side effects (nausea and increased sweating) were recorded and, in particular, no anticholinergic or cardiovascular side effect were observed. 5. Taking into consideration the severity of illness as well as the long and serious anamneses, these results of treatment with citalopram must be considered most satisfactory.

Noxiptilin (Agedal)--a new tricyclic antidepressant with a faster onset of action? A double-blind, multicentre comparison with amitriptyline.

Five psychiatric hospitals in Norway took part in this double blind clinical trial, in which noxiptilin (Agedal) was compared with amitriptyline in hospitalized patients with primary depressive illness. According to total randomization, each patient received either noxiptilin or amitriptyline in semiflexible dosage, usually to a maximum dialy dose of 200-250 mg, for at least three, and possibly six weeks. Thirty patients received noxiptilin and 32 received amitriptyline for at least three weeks. The "total" improvement was assessed in two different ways: 1) By direct global assessment; according to this method, there was a non-significant tendency towards greater improvement on amitriptyline after three and sex weeks, in female and male patients alike. 2) By percentage reduction in total score on Hamilton's rating scale for depression; according to this method, there was a significantly greater improvement on noxiptilin after one week in female but not in male patients. After 2, 3 and 6 weeks there were no significant differences. Thus, this trial seems to support earlier claims that noxiptilin has a faster onset of action than amitriptyline. The two drugs did not differ significantly in their effect on any single symptom, nor in their effect on different types of depression. Both drugs had a better effect in patients with duration of present illness less than three months, than in patients with a duration longer than three months. Noxiptilin had a significantly better effect than amitriptyline in patients with insidious onset of present illness, whereas there was a strong (but non-significant) tendency for a better effect of amitriptyline in patients with a more acute onset of illness. No satisfactory explanation can be offered for this unexpected finding.