title: An evaluation of efficacy and safety of reboxetine in elderly patients affected by "retarded" post-stroke depression. A random, placebo-controlled study.
abstract: Depression occurs frequently in post-stroke patients and appears to be associated with an impairment in their rehabilitation and functional recovery. Although selective serotonin reuptake inhibitors (SSRI) are often used in post-stroke depression (PSD), it has been observed that only a subset of patients is responsive to this treatment. Other patients respond to tricyclic antidepressants or MAO inhibitors, which, however, may not have a favorable profile of safety and tolerability in post-stroke patients. In this double-blinded, placebo-controlled study, we evaluated the efficacy and tolerability of the noradrenaline reuptake inhibitor, reboxetine, in a subset of PSD patients classified as affected by "retarded" depression. Reboxetine (4 mg, twice daily, for 16 weeks) was administered to patients that developed depression after a single ischaemic or hemorrhagic stroke. We assessed the severity of depressive symptoms by the Beck Depression Inventory (BDI) and Hamilton Depression Rating Scale (HDRS). HDRS and BDI scores (mean+/-S.D.) at baseline were, respectively, 24+/-1.31 and 19.87+/-1.46 in the placebo group, 24.06+/-1.52 and 20.56+/-2.16 in the reboxetine group. After 16 weeks, HDRS and BDI mean scores were respectively 22.73+/-2.4 and 18.4+/-3.33 in the placebo group, 9.26+/-2.15 and 8.06+/-3.43 in the reboxetine group [p<0.01 versus the respective baseline (paired t-test); (#)p<0.01 versus retarded depressed patients treated with placebo (one-way analysis of variance (ANOVA) applied to the difference from baseline, associated with Dunnett's t-test to isolate the differences)]. Reboxetine showed a good efficacy, safety and tolerability in PSD patients affected by "retarded" depression. We conclude that reboxetine is well tolerated and may be a useful therapeutic option in PSD patients with "retarded" depression.
authors.affiliation: Department of Neurosciences, University of Catania, Azienda Policlinico-Neurologia, Via S. Sofia 78, Catania I-95125, Italy. rampello@unict.it
authors.forename: Liborio
authors.initials: L
authors.lastname: Rampello
authors.forename: Alessandro
authors.initials: A
authors.lastname: Alvano
authors.forename: Santina
authors.initials: S
authors.lastname: Chiechio
authors.forename: Rocco
authors.initials: R
authors.lastname: Raffaele
authors.forename: Ignazio
authors.initials: I
authors.lastname: Vecchio
authors.forename: Mariano
authors.initials: M
authors.lastname: Malaguarnera
mesh_terms: D000368:Aged; D000928:Antidepressive Agents / Q000009:adverse effects / Q000627:therapeutic use*; D003863:Depression / Q000145:classification / Q000188:drug therapy* / Q000209:etiology; D004311:Double-Blind Method; D004341:Drug Evaluation; D005260:Female; D006801:Humans; D008297:Male; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D000077593:Reboxetine; D012720:Severity of Illness Index; D020521:Stroke / Q000150:complications
chemical_list: D000928:Antidepressive Agents; D009025:Morpholines; D000077593:Reboxetine