Treatment of Young Adults With Comorbid AUD/MDD: A Pilot Medication Trial
| Status: | Recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 30 |
| Updated: | 4/21/2016 |
| Start Date: | June 2015 |
| End Date: | February 2017 |
| Contact: | Jack R Cornelius, M.D., M.P.H. |
| Email: | corneliusjr@upmc.edu |
| Phone: | 412-246-5149 |
Recent reports have shown that alcohol misuse is a particularly serious problem among the 18
to 25 year old age group. Previous medication trials with SSRI antidepressants among young
adults with co-occurring depressive disorders, including our own recent trials with SSRI
medications, have produced disappointing results, especially for decreasing the level of
alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and
mechanism of action. Recent study results suggest that mirtazapine is more effective than
other antidepressants for treating non-comorbid depression. A few recent studies with
mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have
demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol
craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of
alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use
of that comorbid population. The results of our own very recent open label pilot study
suggest robust within-group efficacy for mirtazapine for decreasing both the level of
alcohol use and the depressive symptoms of comorbid subjects. However, that pilot study did
not include a placebo control group, so the efficacy of mirtazapine versus placebo for
decreasing the level of alcohol use among persons with comorbid AUD/MDD remains unclear.
This 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 both the alcohol use and depressive symptoms of young adults with comorbid
AUD/MDD. If results (effect sizes) from the proposed study are found to be promising
concerning outcome differences between the mirtazapine and placebo groups, then we will use
those findings to apply for an R01 study to definitively assess the efficacy of mirtazapine
for treating young adults with AUD/MDD.
to 25 year old age group. Previous medication trials with SSRI antidepressants among young
adults with co-occurring depressive disorders, including our own recent trials with SSRI
medications, have produced disappointing results, especially for decreasing the level of
alcohol consumption. Mirtazapine is a non-SSRI medication with a unique structure and
mechanism of action. Recent study results suggest that mirtazapine is more effective than
other antidepressants for treating non-comorbid depression. A few recent studies with
mirtazapine have been conducted among subjects with comorbid AUD/MDD, and those studies have
demonstrated efficacy for mirtazapine for decreasing the depressive symptoms and the alcohol
craving of subjects with comorbid AUD/MDD. However, those studies did not measure level of
alcohol consumption, so it is unclear whether mirtazapine decreases the level of alcohol use
of that comorbid population. The results of our own very recent open label pilot study
suggest robust within-group efficacy for mirtazapine for decreasing both the level of
alcohol use and the depressive symptoms of comorbid subjects. However, that pilot study did
not include a placebo control group, so the efficacy of mirtazapine versus placebo for
decreasing the level of alcohol use among persons with comorbid AUD/MDD remains unclear.
This 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 both the alcohol use and depressive symptoms of young adults with comorbid
AUD/MDD. If results (effect sizes) from the proposed study are found to be promising
concerning outcome differences between the mirtazapine and placebo groups, then we will use
those findings to apply for an R01 study to definitively assess the efficacy of mirtazapine
for treating young adults with AUD/MDD.
MDD and AUD are each highly prevalent among young adults, and the comorbidity of those two
disorders occurs more often than would be expected by chance alone. The presence of this
comorbidity is associated with increased risk for motor vehicle accidents, relapse to
alcohol use, suicide, recurrence of depressive illness, increased morbidity, and costly
hospitalization. Thus, the comorbidity of AUD/MDD is a highly significant public health
problem among young adults, with considerable unmet treatment needs. Previous medication
trials with SSRI antidepressants involving those co-occurring conditions, including our own
recent trials with SSRI medications, have produced disappointing results, especially for
decreasing the level of alcohol consumption. Mirtazapine is an FDA-approved medication for
treating MDD with a unique pharmacological profile, unrelated to SSRIs. Recent study results
suggest that mirtazapine is more effective than other antidepressants for treating
non-comorbid depression. A few recent studies have demonstrated efficacy for mirtazapine for
decreasing the depressive symptoms and the alcohol craving of subjects with comorbid
AUD/MDD, but those studies did not measure level of alcohol consumption. Therefore, it is
unclear whether mirtazapine decreases the level of alcohol use of that comorbid population.
Our own recent pilot data suggest within-group efficacy for mirtazapine for decreasing both
the excessive alcohol use and the depressive symptoms of persons with comorbid AD/MDD.
However, that pilot study did not include a placebo control group, so the efficacy of
mirtazapine for decreasing the level of alcohol use among persons with comorbid AUD/MDD
remains unclear. To date, no double-blind, placebo-controlled study has even been conducted
to assess whether mirtazapine decreases both the level of drinking and the depressive
symptoms of young adults with comorbid AD/MDD. In this submission, we propose a proof of
concept, double-blind, placebo-controlled pilot trial to provide a preliminary assessment of
the efficacy of the medication mirtazapine vs. placebo in the treatment of young adults with
co-occurring alcohol use disorders (AUD) and major depression (MDD). If results (effect
sizes) from the proposed study are found to be promising concerning outcome differences
between the mirtazapine and placebo groups, then we will use those findings to apply for an
R01 study to definitively assess the efficacy of mirtazapine for treating young adults with
AUD/MDD.
disorders occurs more often than would be expected by chance alone. The presence of this
comorbidity is associated with increased risk for motor vehicle accidents, relapse to
alcohol use, suicide, recurrence of depressive illness, increased morbidity, and costly
hospitalization. Thus, the comorbidity of AUD/MDD is a highly significant public health
problem among young adults, with considerable unmet treatment needs. Previous medication
trials with SSRI antidepressants involving those co-occurring conditions, including our own
recent trials with SSRI medications, have produced disappointing results, especially for
decreasing the level of alcohol consumption. Mirtazapine is an FDA-approved medication for
treating MDD with a unique pharmacological profile, unrelated to SSRIs. Recent study results
suggest that mirtazapine is more effective than other antidepressants for treating
non-comorbid depression. A few recent studies have demonstrated efficacy for mirtazapine for
decreasing the depressive symptoms and the alcohol craving of subjects with comorbid
AUD/MDD, but those studies did not measure level of alcohol consumption. Therefore, it is
unclear whether mirtazapine decreases the level of alcohol use of that comorbid population.
Our own recent pilot data suggest within-group efficacy for mirtazapine for decreasing both
the excessive alcohol use and the depressive symptoms of persons with comorbid AD/MDD.
However, that pilot study did not include a placebo control group, so the efficacy of
mirtazapine for decreasing the level of alcohol use among persons with comorbid AUD/MDD
remains unclear. To date, no double-blind, placebo-controlled study has even been conducted
to assess whether mirtazapine decreases both the level of drinking and the depressive
symptoms of young adults with comorbid AD/MDD. In this submission, we propose a proof of
concept, double-blind, placebo-controlled pilot trial to provide a preliminary assessment of
the efficacy of the medication mirtazapine vs. placebo in the treatment of young adults with
co-occurring alcohol use disorders (AUD) and major depression (MDD). If results (effect
sizes) from the proposed study are found to be promising concerning outcome differences
between the mirtazapine and placebo groups, then we will use those findings to apply for an
R01 study to definitively assess the efficacy of mirtazapine for treating young adults with
AUD/MDD.
Inclusion Criteria:
- DSM-IV-TR diagnosis of current alcohol dependence, confirmed by the Mini
International Neuropsychiatric Interview (MINI)
- DSM-IV-TR diagnosis of current major depressive disorder, confirmed by the Mini
International Neuropsychiatric Interview (MINI)
Exclusion Criteria:
- Any person who meets criteria for alcohol-induced depression
- Any psychotic disorder bipolar disorder, mental retardation, impaired cognitive
functioning, or use of any psychotropic medication in the previous month
- Current Diagnostic and Statistical Manual (DSM-IV) criteria for dependence on
substances other than alcohol, cannabis, nicotine, or caffeine
- Significant neurological conditions or medical conditions
- Persistent elevation of liver function enzymes indicating active liver disease
(elevated t. bilirubin or elevation to three-time normal range of liver enzymes,
SGOT, SGPT, or g-GTP)
- The presence of renal function impairment defined as serum creatinine >2x upper limit
of normal
- Pregnancy, inability or unwillingness to use contraceptive methods
- Use of any antidepressant medication in the prior two months, or any lifetime use of
mirtazapine
- Inability to read or understand study forms and agree to informed consent
We found this trial at
1
site
Pittsburgh, Pennsylvania 15213
Principal Investigator: Jack R. Cornelius, M.D., M.P.H.
Phone: 412-246-6906
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