Trimipramine is equivalent to combined treatment with amitriptyline and haloperidol in patients with delusional depression

Our recent study suggests that trimipramine (TR) monotherapy is effective in delusional depression. We tested this hypothesis in a randomized double-blind multicentre study.Participants were 94 inpatients (ICD–10 diagnoses F 31.5, 32.2 or 33.3) in 16 hospitals in Austria, Germany and Switzerland.Either TR (up to 400mg) or standard (ST, amitriptyline up to 200mg, combined with haloperidol up to 7.5mg) were given for 6 weeks. Possible comedications were 2g chloralhydrate and, until day 14, up to 7.5mg lorazepame. Psychometry including the Hamilton score (HAMD, 24 items) was assessed weekly. The hypothalamo-pituitary-adrenocortical (HPA) axis was examined by the dexamethasone-corticotropine-releasing hormone (DEX-CRH) test. The per-protocol population consisted of 57 patients (19 to 82 yrs). 18 women and 15 men received TR. ST was given to 16 women and 8 men.During the trial HAMD decreased significantly from 35.7±8.6 to 9.4±8.3 after TR or from 35.7±8.3 to 11.8±9.0 after ST. That means TR is not inferior to ST in reducing HAMD. After TR 84.8% of the patients were responders (HAMD reduced ≤ 50%) and 54.6% were remitted (HAMD ≤ 8). After ST these figures were 70.8% or 45.8%. Between baseline and day 42 HPA hormones at the Dex-CRH-test decreased in both groups.Side effects occurred in 73.5% of the TR and in 81.4% of the ST patients. Our data confirm that TR is an effective and safe treatment of delusional depression.HPA suppression is thought to contribute to its action.