Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
Status:
Completed
Trial end date:
2016-07-01
Target enrollment:
Participant gender:
Summary
Mirtazapine is a non-SSRI (selective serotonin reuptake inhibitor) medication with a unique
structure and mechanism of action. Recent study results suggest that mirtazapine may be more
effective and faster acting than other antidepressants. Levels of alcohol use have been shown
to be associated with levels of depressive symptoms among comorbid populations. Our own
recent open label pilot study suggested robust within-group efficacy for mirtazapine for
decreasing both the drinking and the depressive symptoms of persons with co-occurring alcohol
dependence/major depressive disorder (AD/MDD). However, no placebo control group was employed
in that study, so between-group efficacy versus placebo could not be assessed. The current
grant submission proposes to conduct a first double-blind, placebo-controlled study to
evaluate the efficacy of mirtazapine versus placebo for decreasing the alcohol use and
depressive symptoms of persons with comorbid AD/MDD. If the results of this proposed
double-blind pilot trial are promising, then the effect sizes found in this proposed study
will be used to help design an adequately-powered R01 treatment trial to definitively test
the efficacy of mirtazapine in this comorbid population.
Phase:
Phase 2
Details
Lead Sponsor:
University of Pittsburgh
Collaborator:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)