One hundred and twelve patients suffering from moderate to severe major depression (DSM III) were enrolled into a study to compare the antidepressant activity and side effect profiles of two dosage groups of minaprine (200 mg and 300 mg per day) and one of imipramine (150 mg per day) in psychiatric practice. Eight patients were withdrawn because of unwanted effects (four imipramine, one minaprine 200 mg, three minaprine 300 mg) and seventy-eight spontaneous reports of unwanted effects were made from the imipramine group compared with sixty-four from the minaprine 200 mg and forty-six from the minaprine 300 mg groups. The main efficacy analysis was carried out at 4 weeks on the 89 evaluable patients who completed 2 weeks active treatment, the last observation being carried forward in those patients who did not complete. A secondary analysis was also carried out at 6 weeks. The response in all three treatment groups showed a significant improvement from the severity at entry to the study, and the response rate to minaprine 200 mg daily was similar to that of imipramine (53% vs 54% achieving a reduction of 50% or more on the Hamilton Depression Rating Scale by week 6), although, given the small group sizes, similar efficacy cannot be claimed. In the intention to treat analysis there was a significant dose response relationship with significantly more patients in the lower minaprine 200 mg dose group achieving 50% or more reduction in the Hamilton Rating Scale than the minaprine 300 mg group at week 4 (p less than 0.05).(ABSTRACT TRUNCATED AT 250 WORDS)

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