Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Depression, Depression, Major Depression Disorder (MDD), Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 18 - 55 |
| Updated: | 4/21/2016 |
| Start Date: | September 2013 |
| End Date: | March 2016 |
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.
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.
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.
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.
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
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