Efficacy and Tolerability of Reboxetine Compared with Citalopram: A Double-blind Study in Patients with Major Depressive Disorder


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Abstract

The objective of this study was to compare efficacy and tolerability of the selective noradrenalin reuptake inhibitor reboxetine with the selective serotonin reuptake inhibitor citalopram, in the treatment of major depressive disorder (MDD). In total, 357 outpatients with MDD were randomized to treatment with reboxetine 8-10 mg or citalopram 20-40 mg per day during 24 weeks. Primary end-point was change from baseline in the Hamilton Depression Rating Scale (HAM-D, 21 items). Sexual function/dysfunction was measured by the Sexual Function scale (SF). Observed case analysis showed that both treatments yielded a gradual reduction of HAM-D scores: reboxetine with -21.4 and citalopram with -22.1 points (NS). LOCF analysis showed a greater reduction of the HAM-D scores with citalopram compared with reboxetine (-19.6 vs. -17.8; P = 0.034). The response rate was 90.3% for reboxetine and 92.7% for citalopram (NS). The most common side effect in the reboxetine group was dry mouth, and in the citalopram group sexual dysfunction. At week 24, anorgasmia was reported by 5.9% of the sexually active women in the reboxetine group vs 39% in the citalopram group.The dropout number was 91 in the reboxetine group, and 54 in the citalopram group. To summarize, both treatments gave a satisfactory antidepressant effect. The side effect profile differed between the groups, with a notably high prevalence of sexual dysfunctions in the citalopram group. The high number of dropouts in the reboxetine group, is considered as a result of the non-titration starting dose of 8 mg reboxetine per day, which gave a high incidence of early side-effects.Depressive disorders including major depression (MDD) is very common, with a lifetime prevalence of at least 15% in men and 25% in women.1,2 Depression can be treated effectively by a range of antidepressant agents. Recent reviews have suggested that the selective serotonin reuptake inhibitors (SSRIs) offer equal efficacy to the older antidepressant agents, such as tricyclic antidepressants, with the advantage of greater tolerability.3-5 Other reviewers have reported that non-SSRI antidepressants, such as clomipramine, have been found to be significantly more effective than fluoxetine for the treatment of patients with severe depression.6Reboxetine (reboxetine mesylate, Edronax; Pfizer, New York) is a highly selective noradrenaline reuptake inhibitor, and the efficacy of reboxetine has been independently demonstrated in multiple randomized, double-blind, placebo-controlled studies.7-9 In addition to improvements in depressive symptoms, treatment-associated improvements in social behavior (measured using the Social Adaptation Self-evaluation Scale [SASS]),10 were noticed in one of these studies.8 In this study, reboxetine was statistically and clinically superior to both placebo and fluoxetine in improving social functioning.The primary objective of the current study was to assess efficacy and tolerability of reboxetine in comparison with those of citalopram (Cipramil; H. Lundbeck, Copenhagen, Denmark) in patients with MDD. Citalopram is a highly SSRI. The antidepressant mechanism is presumed to be a result of stimulation of serotonergic neurotransmission in the central nervous system as a consequence of higher serotonin levels resulting from inhibition of the serotonin transporter. The therapeutic efficacy of citalopram in patients with MDD has been investigated in several placebo-controlled studies and in long-term and extension studies.11 The underlying rationale for this comparison was to study 2 different drug profiles, 1 drug being pure "adrenergic" and the other pure "serotonergic." A secondary objective was to analyze the correlation between the types of depression (ie, degree of melancholia and the efficacy of the 2 drugs).

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