Status:
COMPLETED
Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
National Institute on Alcohol Abuse and Alcoholism (NIAAA)
Conditions:
Major Depressive Disorder
Alcohol Use Disorder
Eligibility:
All Genders
18-55 years
Phase:
PHASE2
Brief 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 f...
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 significa...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2016
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT02185131
Start Date
September 1 2013
End Date
July 1 2016
Last Update
May 5 2017
Active Locations (1)
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1
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, United States, 15213