A 12-week study comparing moclobemide and sertraline in the treatment of outpatients with atypical depression

Abstract

One hundred and ninety-seven outpatients with atypical depression [Atypical Depression Diagnostic Scale (ADDS) score=4] were randomized to 12 weeks of double-blind treatment with sertraline or moclobemide in a multicentre, parallel-group clinical trial. Patients were started on either 50 mg/day sertraline or 300 mg/day moclobemide. If the therapeutic response was not satisfactory after 4 weeks, the dose could be increased to either 100 mg/day sertraline or 450 mg/day moclobemide. Primary efficacy evaluations were the 29-item Hamilton Psychiatric Rating Scale for Depression (HAM-D) and the Clinical Global Impression of Improvement (CGI-I) response rate (much or very much improved) at study endpoint. Secondary efficacy evaluations included the ADDS, the Hamilton Anxiety Scale (HAMA), the Leeds Sleep Scale, and the Battelle Quality of Life Battery (BQOLB). In the analysis of the 172 patient efficacy-evaluable population, there was significant baseline to endpoint improvement in all primary and secondary efficacy assessments after treatment with either sertraline or moclobemide. At the endpoint, the proportion of responders on CGI-I, was 77.5% in the sertraline group and 67.5% in the moclobemide group (p=0.052). The baseline to endpoint mean 29-item HAM-D score decreased from 35.9 to 14.5 in the sertraline group and from 36.3 to 16.1 in the moclobemide group. Sertraline also resulted in a significantly (p < 0.05) greater degree of improvement at the endpoint, compared with moclobemide, in the proportion of remitters on the HAMA (total score < or = 7), ADDS Category IID (Rejection Sensitivity), Leeds Sleep Factor 4 (Integrity of Behaviour Following Awakening), and on three dimensions of the BQOLB (Energy/Vitality, Social Interaction and Life Satisfaction). There were no other significant differences between treatment groups. Overall, both medications were well tolerated. In this study, both sertraline and moclobemide improved the symptoms of atypical depression.

An Open-Label, Rater-Blinded, Flexible-Dose, 8-Week Trial of Escitalopram in Patients With Major Depressive Disorder With Atypical Features

“…The CGIbased response rate in our study is comparable to the CGI-based response rates seen in randomized controlled clinical trials with fluoxetine (51%), imipramine (53%), phenelzine (61%-85%), sertraline (77.5%), and moclobemide (67.5%) in MDD with atypical features. 3,[15][16][17][18] Interestingly, the magnitude of improvement in primary outcome measure and responder rate was consistent with the results from registration clinical trials of escitalopram for MDD. [36][37][38] In addition, our responders continued to maintain their response until the end of study, without fluctuation of the response.…”

“…16 These 2 studies support the use of SSRIs for atypical depression, but conclusions are limited by small sample sizes and lack of placebo arms. A randomized, parallel group, 12-week study comparing moclobemide and sertraline in the treatment of outpatients with MDD with atypical features (N = 197) also demonstrated that both medications produced comparable improvement 17 ; this larger study provides useful data, although it too is limited by the lack of a placebo arm and has been criticized 14 due to the suboptimal dose used in the moclobemide arm (mean dose of 410.2 mg/day). A 10-week, randomized, placebo-controlled study of MDD with atypical features (N = 154) showed that fluoxetine was superior to placebo, was comparable to imipramine in terms of efficacy, and was better tolerated than imipramine.…”

Atypical Depression: Useful Concept, but it's Time to Revise the DSM-IV Criteria

“…As moclobemide, a selective and reversible inhibitor of MAO A (RIMA), appears to be less effective than older MAOIs such as phenelzine and DSM-IV criteria for atypical depression ME Thase tranylcypromine (Lotufo-Neto et al, 1999), the metaanalysis may have overestimated the relative effectiveness of the SSRIs. Consistent with this, strong trends favored sertraline over moclobemide in the larger of the two studies of the RIMA (Sogaard et al, 1999). Nevertheless, it is true that in the only study to contrast an SSRI, fluoxetine (n ¼ 20), with phenelzine (n ¼ 20), both treatments were highly effective and tolerability indices favored the newer medication (Pande et al, 1996).…”

Atypical Depression

“…Ancak son 10 yıl içerisinde yapılmış olan çalışmalar atipik depresyon tanı ölçütlerinin geçerliliğini yeniden tartışmaya açmıştır. [41][42][43][44][45][46][47][48][49] DSM-IV sonrası yapılan çalışmalar depresyonda atipik özelliğin major depresyona ve distimiye dahil edilmesini destek-lemiştir, ancak bu çalışmalar atipik depresyonlu hastaların hastalık seyri, biyoloji, tedavi yanıt beklentisi ve ailesel yüklülük açısından farklı olduğunu dü-şündürmüştür. [44] Bugün için en tartışmalı olduğu iddia edilen tanı ölçütü duygudurumda tepkisellik olmuştur.…”

“…Sogaard ve arkadaşları sertralin'in atipik depresyon tedavisinde moklobemid'den anlamlı olarak daha etkin olduğunu bildirmişlerdir. [41] Pande ve arkadaşları 42 atipik depresyon olgusunda fluoksetin'i, fenelzin kadar etkili olduğunu bulmuşlardır. Fluoksetin daha az yan etki göstermiş ve daha iyi tolere edilmiştir.…”