This proposal is written in response to PA-10-252 entitled, "Treatment of Co-Occurring Alcohol Use Disorders and Depression/Anxiety Disorders (R21)". Alcohol dependence (AD) and Major Depressive Disorder (MDD) are among the most frequent psychiatric disorders in the general population, and the co-occurrence of those disorders represents a significant public health problem. Levels of alcohol use have been shown to be associated with levels of depressive symptoms among comorbid populations. Previous medication trials with SSRI antidepressants in this comorbid population have produced disappointing results. Mirtazapine is a non-SSRI 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. Our own recent open label pilot study suggested robust within-group efficacy for mirtazapine for decreasing both the drinking and the depressive symptoms of AD/MDD subjects. 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 pilot study to provide a preliminary assessment of 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 study 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 versus placebo in this comorbid population.

Public Health Relevance

Mirtazapine is a non-SSRI 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.

Agency
National Institute of Health (NIH)
Institute
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Type
Exploratory/Developmental Grants (R21)
Project #
1R21AA022123-01A1
Application #
8620304
Study Section
Special Emphasis Panel (ZAA1-DD (03))
Program Officer
Roach, Deidra
Project Start
2013-09-26
Project End
2015-08-31
Budget Start
2013-09-26
Budget End
2014-08-31
Support Year
1
Fiscal Year
2013
Total Cost
$181,391
Indirect Cost
$62,641
Name
University of Pittsburgh
Department
Psychiatry
Type
Schools of Medicine
DUNS #
004514360
City
Pittsburgh
State
PA
Country
United States
Zip Code
15213
Cornelius, Jack R; Chung, Tammy; Douaihy, Antoine B et al. (2016) Mirtazapine in comorbid major depression and an alcohol use disorder: A double-blind placebo-controlled pilot trial. Psychiatry Res 242:326-30
Cornelius, Jack R; Kirisci, Levent; Reynolds, Maureen et al. (2015) Does the Transmissible Liability Index (TLI) assessed in late childhood predict suicidal symptoms at young adulthood? Am J Drug Alcohol Abuse 41:264-8
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The "S" Allele of the Serotonin Transporter Is Not Associated with Major Depression in a Sample OF Veterans. Adv Genet Res 12:1-10
Cornelius, Jack R; Haas, Gretchen L; Goldstein, Gerald et al. (2014) The "S" Allele of the Serotonin Transporter Is Not Associated with Major Depression or Alcohol Use Disorders in a Veteran Sample. Int J Med Biol Front 20:103-111
Cornelius, Jack; Kirisci, Levent; Reynolds, Maureen et al. (2014) Does stress mediate the development of substance use disorders among youth transitioning to young adulthood? Am J Drug Alcohol Abuse 40:225-9
Cornelius, Jack R; Kirisci, Levent (2013) Assessing TLI as a Predictor of Treatment Seeking for SUD among Youth Transitioning to Young Adulthood. Adv Psychol Res 98:85-94
Cornelius, Jack R; Douaihy, Antoine B; Kirisci, Levent et al. (2013) LONGER-TERM EFFECTIVENESS OF CBT IN TREATMENT OF COMORBID AUD/MDD ADOLESCENTS. Int J Med Biol Front 19:
Cornelius, Jack R (2013) Editorial Regarding the New DSM-5 Diagnosis of PTSD in Veterans and Non-veterans. J Depress Anxiety 2:139-141
Cornelius, Jack R; Douaihy, Antoine B; Clark, Duncan B et al. (2013) Mirtazapine in Comorbid Major Depression and Alcohol Use Disorder: A Long-Term Follow-Up Study. J Addict Behav Ther Rehabil 3:
Cornelius, Jack R; Aizenstein, Howard J; Chung, Tammy A et al. (2013) Paradoxical Decrease in Striatal Activation on an fMRI Reward Task Following Treatment in Youth with Co-morbid Cannabis Dependence/Major Depression. Adv Psychol Res 93:123-130