A randomized, double-blind, parallel-group, 6-week study was undertaken to compare the efficacy and tolerability of once or twice daily administration of the selective serotonin reuptake inhibitors paroxetine and fluoxetine. After a 1-week placebo wash-out, patients suffering from DSM-III major depression and with a score of 18 or more on the 21-item Hamilton Rating Scale for Depression (HRSD) received either paroxetine or fluoxetine. The patients were assessed for efficacy using the HRSD, Montgomery-Asberg Depression Rating Scale and Clinical Global Impression; for tolerability, adverse events were elicited by the use of a non-leading question and a side effects checklist. The groups of patients were comparable on entry to the study. One hundred patients were recruited into the study, of whom 78 were evaluable for the efficacy analysis. Paroxetine and fluoxetine showed comparable efficacy at the end of the 6-week treatment period, but a statistically significant difference in the number of responders at week 3 in favour of paroxetine was observed. This could suggest an earlier onset of action with paroxetine. Also, associated anxiety symptoms were significantly reduced on paroxetine compared with fluoxetine at week 3. Patients on paroxetine reported fewer adverse events than those on fluoxetine. The most commonly reported adverse events were nausea and vomiting in both groups.
In a double-blind multicentre trial in patients with major depression, the efficacy and the tolerability of sertraiine were compared with those of fluoxetine, during an eight-week acute treatment phase followed by a 24-week continuation treatment phase in treatment responders.A total of 165 patients who met DSM III-R criteria for moderate to severe major depression were randomized to receive either sertraline or fluoxetine for short-term and continuation treatment with initial daily dosages of either 50 mg of sertraline or 20 mg of fluoxetine. In the event of an inadequate response after 4 weeks of double-blind therapy these doses could be doubled.Both treatment groups demonstrated similar improvements on both the Hamilton Rating Scale for Depression (HAM-D) and the Montgomery and Asberg Depression Rating Scale (MADRS), during the acute phase as well as during the continuation phase. Both sertraline and fluoxetine were well tolerated, the most common side-effects being gastrointestinal symptoms. Significantly more patients in the fluoxetine-treatment group experienced activating adverse events.The study demonstrates similar antidepressant efficacy and tolerability for sertraline and fluoxetine in acute and continuation treatment and equivalence of sertraline 50 rng daily with fluoxetine 20 mg daily in the treatment of depression.
The efficacy and the tolerance of milnacipran (100 mg/day), a second generation antidepressant which equipotently inhibits both noradrenaline and serotonin reuptake, was compared to fluoxetine (20 mg/day), a selective serotonin reuptake inhibitor, in two parallel groups of, respectively, 97 and 93 major depressive outpatients. The duration of the study was 6 weeks, with assessments every 2 weeks by means of the Montgomery and Asberg depression scale (MADRS), the Hamilton depression scale, the clinical global impressions (CGI), and a checklist of symptoms and side-effects. Results showed significant superiority of fluoxetine over milnacipran on most rating instruments: MADRS (P = 0.01) including five individual items, Hamilton depression scale (P = 0.002) including ten individual items, CGI of severity (P = 0.01) and therapeutical index (P = 0.002). On visual analogue scales assessing the clinical profile of the compounds, fluoxetine was rated as exhibiting more psychostimulating activity than milnacipran (P = 0.0008). The tolerance of the two antidepressants was very similar, with the exception of symptoms of dizziness which were more frequently reported with milnacipran (P = 0.01). These differences in efficacy favoring fluoxetine could result from the selection of a dose of milnacipran below the optimal therapeutic dose for this type of psychiatric patients or to the administration of the compounds in single daily intakes, whereas milnacipran possesses a plasma elimination half-life of only 7 h.
A multicentre study compared the antidepressant efficacy and the tolerance of two selective serotonin reuptake inhibitors, paroxetine (20–30 mg/d) and fluvoxamine (50–200 mg/d) in two parallel groups of respectively 56 and 64 patients with major depression, as defined by DSM‐III‐R criteria. The duration of the study was six weeks, with assessments at baseline and at the end of weeks 1, 2, 4, and 6. For efficacy the Hamilton depression, the Hamilton anxiety scales and the clinical global impressions were used; adverse events were assessed by means of a non‐leading question. Results showed a similar improvement in both groups on all rating instruments. The total number of patients reporting adverse events did not significantly differ between paroxetine (52 per cent) and fluvoxamine (64 per cent); severe adverse events were however significantly less frequently reported with paroxetine than with fluvoxamine (13 per cent versus 28 per cent), and resulted less frequently in the discontinuation of treatment (5 per cent versus 17 per cent).
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