Fluvoxamine and imipramine in the treatment of depressive patients: a double-blind controlled study.

A double-blind, controlled study was carried out in 20 patients diagnosed as suffering from depressive disorder according to DSM-III criteria to compare the effectiveness and tolerability of fluvoxamine, a serotonin re-uptake inhibitor, with that of imipramine. Patients were allocated at random to receive one or other drug for a period of 4 weeks, dosage starting at 50 mg for the first 3 days and increasing to 100 mg daily for a further 3 days. Dosage was continued at this level for the remainder of the trial but was increased, if necessary, to 150 mg daily in two divided doses. Assessments of symptom severity were made on entry and response after 1, 2 and 4 weeks of treatment using the Hamilton Rating Scale for Depression, the Clinical Global Impression and a Visual Analogue Scale. Tolerability was assessed using the Dosage Record and Treatment Emergent Symptom Scale. The results showed that at the end of the trial there was a significant reduction in depressive symptoms severity in both groups and that fluvoxamine was significantly more effective than imipramine in reducing suicidal ideas and anxiety/somatic symptoms. Both drugs were relatively well tolerated but the side-effect profiles were different, being mainly of the anticholinergic type with the tricyclic and gastro-intestinal with fluvoxamine.

RCT Entities:   Population Interventions Outcomes