Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
Information source: University of Pittsburgh
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Major Depressive Disorder; Alcohol Use Disorder
Intervention: Mirtazapine (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: University of Pittsburgh Official(s) and/or principal investigator(s): Jack R Cornelius, M.D., M.P.H., Principal Investigator, Affiliation: University of Pittsburgh
Overall contact: Jack R Cornelius, M.D., M.P.H., Phone: 412-246-5149, Email: corneliusjr@upmc.edu
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.
Clinical Details
Official title: Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Number of drinks per weekLevel of Depressive Symptoms
Detailed description:
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.
Eligibility
Minimum age: 18 Years.
Maximum age: 55 Years.
Gender(s): Both.
Criteria:
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
Locations and Contacts
Jack R Cornelius, M.D., M.P.H., Phone: 412-246-5149, Email: corneliusjr@upmc.edu
Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania 15213, United States; Recruiting Maribeth A Wesesky, C.M.A., Phone: 412-246-6906, Email: weseskyma@upmc.edu Jack R Cornelius, M.D., M.P.H., Phone: 412-246-5149, Email: corneliusjr@upmc.edu Jack R. Cornelius, M.D., M.P.H., Principal Investigator
Additional Information
Related publications: Cornelius JR, Douaihy AB, Clark DB, Chung T, Wood DS, Daley D. Mirtazapine in Comorbid Major Depression and Alcohol Dependence: An Open-Label Trial. J Dual Diagn. 2012 Sep 1;8(3):200-204. Epub 2012 Aug 8.
Starting date: September 2013
Last updated: July 3, 2014
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