1 A double-blind placebo-controlled study of fluvoxamine and imipramine was performed in a group of depressed patients. Twenty-two patients received fluvoxamine (mean dose 101 mg/day), 25 received imipramine (mean dose 127 mg/day) and 22 received placebo.

2 Apart from an increase in the SGOT and SGPT values of four imipramine patients, no statistically significant changes in haematology or urinalysis were judged to be medically relevant. Fluvoxamine exhibited fewer anticholinergic side effects than imipramine.

3 Both fluvoxamine treated patients and imipramine-treated patients exhibited a statistically significant improvement at the end of the 28-day treatment period with respect to the placebo patients, as measured using the Hamilton Rating Scale for Depression, and the Clinical Global Impression Scale. Evaluations of the results of the Beck Depression Inventory and the Profile of Mood States revealed a statistically significant improvement for imipramine patients with respect to placebo at week 4, but not for fluvoxamine patients. It is postulated on the basis of quantitative pharmaco-EEG findings, that the slight superiority of imipramine over fluvoxamine was due to underdosing of the latter.

A double-blind placebo-controlled study of fluvoxamine and imipramine in out-patients with primary depression.

Two major questions were asked in this study involving 3 comparable groups of ten healthy normal volunteers: first, whether it is possible to differentiate between the effect of orally administered single doses of placebo, minor and major tranquilizers utilizing quantitatively analyzed SEP's, and, second, whether or not one can classify, based on previously established drug profiles, the clinical effectiveness of a new compound. Placebo did not produce any relevant or significant alterations of the SEP pattern. Thirty-five mg of chlordiazepoxide induced a significant latency increase of peaks in the early part as well as a decrease in the late part of the secondary response. Concerning the amplitude measurements, a decrease in all peaks was observed, reaching a level of statistical significance in the late response. Five mg of diazepam produced similar changes, which, however, reached a level of statistical significance only in the amplitudes. In contrast to minor tranquilizers, 50 mg chlorpromazine prolonged the latency of all peaks; the later the peaks, the greater were the changes. The amplitudes were attenuated significantly in the late response, but showed a tendency to increase in the primary response. After determination of the drug profiles of these clinically known psychotropic drugs, the effects on the SEP of the new compound, SCH-12,041 were investigated. Based on the latency increase of the early part and latency decrease of the late part of the secondary response, as well as the decrease in amplitude, it was suggested that this new compound will act similar to chlordiazepoxide which was confirmed by clinical trials. The significance of the findings will be discussed.

Effect of minor and major tranquilizers on somatosensory evoked potentials.

Citalopram, a new phthalane derivative and a specific serotonin re-uptake inhibitor in animal pharmacological tests, was evaluated in a double-blind, crossover, quantitative pharmaco-EEG (QPEEGTM) study in healthy human volunteers. The CNS effects of citalopram are linear, dose- and time-related, can statistically be differentiated from placebo, and indicate a rapid onset of effects with short duration. According to the Computer Data Bank, citalopram has a mode of action similar to mood elevators (antidepressants) with fewer sedative properties. Thus the therapeutic action of citalopram is predicted to be similar to desipramine and protriptyline from the tricyclics, and fluvoxamine from non-tricyclics. According to data bank assessment, it is hypothesized that the single antidepressant dose of citalopram is to be more than 25 mg, which should be given t.i.d. in clinical trials.

CNS effects of citalopram, a new serotonin inhibitor antidepressant (a quantitative pharmaco-electroencephalography study).

The main purposes of this study were to examine the effects of one-day treatment of anxiety and to test whether significant relief of anxiety can be achieved in a short time period by frequency individual adjustment of doses. A double-blind crossover study of halazepam and placebo was carried out with 22 patients, 20 completing the study. Each treatment lasted for one day. Oral medication was administered starting with a dose of 40 mg and the dose adjusted every 2 hours. The total daily dose did not exceed 600 mg. Several rating and self-rating scales were used. All observer rating scales and several self-rating scales discriminated at a significant level. The design appeart to be suitable for the rapid screening for anti-anxiety properties of new drugs.

The effects of one-day treatment of anxiety with high doses of halazepam.

A single bedtime dose of 120 mg of halazepam was effective in the treatment of patients with mild to moderate anxiety. This dose was superior to both placebo and a 60 mg dose in this 2-week study, as shown by both physician and patient rating scales. The safety of single bedtime doses of halazepam was confirmed. All the reported side-effects were known adverse experiences to benzodiazepines in general.

A Double-Blind Parallel-Group Comparison of Single Bedtime Doses of Halazepam and Placebo

SCH-12,041, a new anti-anxiety agent (quantitative pharmaco-electroencephalography and clinical trials).

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SCH-12,041, a new anti-anxiety agent (quantitative pharmaco-electroencephalography and clinical trials).