Mirtazapine in comorbid major depression and alcohol use disorder: A long-term follow-up study.

To date, pharmacotherapy trials of people with both major depression disorder and alcohol use disorder (MDD/AUD) have focused on SSRI medications, with disappointing results, so effective treatments for that comorbid population are lacking. Mirtazapine is an FDA-approved medication for treating MDD with a unique pharmacological profile whose efficacy may exceed that of SSRIs. Results from a previous CTN platform study suggested acute phase efficacy for mirtazapine for decreasing both the depression and the drinking of the study population. However, to date, no studies have evaluated the longer-term efficacy of mirtazapine in those with MDD/AUD. This article reports on findings from a first long-term (two-year) naturalistic follow-up evaluation involving subjects from the acute phase trial, with the hypothesis that improvements would persist through follow-up.

The original CTN platform study was an eight-week open label study of mirtazapine and motivation therapy, conducted with persons age 18-55 with DSM-IV diagnoses of comorbid MDD/AUD. Two years after entry into the acute phase of the study, a long-term evaluation was conducted using the same instruments that had been used at baseline to assess whether the improvements seen during the acute phase trial had persisted.

Ten of the 12 patients who entered the acute phase study participated in the follow-up study. The large magnitude improvements in depressive symptoms, drinking, and sleep disturbances persisted at the follow-up evaluation. Two of the subjects demonstrated MDD on structured interview at follow-up, while all 10 had demonstrated MDD at baseline. Six of the 10 used antidepressants during the follow-up period. At baseline, 3 were employed, while at follow-up 7 were.

Conclusions: These findings suggest long-term efficacy for mirtazapine for decreasing the drinking and depression of depressed alcoholics. The magnitude of the improvements in depressive symptoms, in level of drinking, and in level of sleep problems noted in this study were consistently greater than the improvements in those symptoms noted in the authors’ previous studies using the SSRI antidepressant fluoxetine in comorbid populations. Double-blind, placebo-controlled studies are warranted to clarify the efficacy of mirtazapine in depressed alcoholics.