Phase 2 N=16 Randomized Triple-blind Treatment

Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.

Major Depressive Disorder · Alcohol Use Disorder

Bottom Line

View on ClinicalTrials.gov: NCT02185131 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2017

Primary outcome: Primary: Drinks Per Drinking Day — 3.5; 4.4 Drinks per drinking day

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Mirtazapine (Drug); Placebo (Drug)
Age: Adult · 18+ yrs
Sex: All
Sponsor: University of Pittsburgh
Primary completion: Jul 2016

Outcome Measures

Outcome	Result	p-value
PRIMARY Drinks Per Drinking Day	3.5; 4.4	—
PRIMARY Level of Depressive Symptoms	27.6; 26.1	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02185131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.