- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185131
Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD. (PT-MAD)
March 24, 2017 updated by: Jack Cornelius, University of Pittsburgh
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, United States, 15213
- Western Psychiatric Institute and Clinic
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 53 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Mirtazapine
Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m.
Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
|
Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m.
Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Other Names:
Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m.
Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
|
Active Comparator: Placebo
Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m.
Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
|
Gelatin capsules mirtazapine 15 mg, 1 capsule every a.m.
Medication will be increased by one capsule, to a dose of 2 capsules barring side effects, at Week 2.
Other Names:
Gelatin capsules Placebo capsules, identical to mirtazapine capsules, 1 capsule every a.m.
Medication will be increased by one capsule to 2 capsules at Week 2, barring any side effects.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Drinks Per Drinking Day
Time Frame: 12 Weeks
|
Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.
|
12 Weeks
|
Level of Depressive Symptoms
Time Frame: 12 Weeks
|
Level of depressive symptoms, as indicated by the score on the Beck Depression Inventory.
The Beck Depression Inventory II scoring range is as follows: 0-13 minimal depressive symptoms, 14-19 mild depressive symptoms, 20-28 moderate depressive symptoms and 29-63 severe depressive symptoms.
|
12 Weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Jack R Cornelius, M.D., M.P.H., University of Pittsburgh
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Cornelius JR, Chung T, Douaihy AB, Kirisci L, Glance J, Kmiec J, FitzGerald D, Wesesky MA, Salloum I. Mirtazapine in comorbid major depression and an alcohol use disorder: A double-blind placebo-controlled pilot trial. Psychiatry Res. 2016 Aug 30;242:326-330. doi: 10.1016/j.psychres.2016.06.005. Epub 2016 Jun 15.
- 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. doi: 10.1080/15504263.2012.696527. Epub 2012 Aug 8.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2013
Primary Completion (Actual)
July 1, 2016
Study Completion (Actual)
July 1, 2016
Study Registration Dates
First Submitted
June 26, 2014
First Submitted That Met QC Criteria
July 3, 2014
First Posted (Estimate)
July 9, 2014
Study Record Updates
Last Update Posted (Actual)
May 5, 2017
Last Update Submitted That Met QC Criteria
March 24, 2017
Last Verified
March 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Chemically-Induced Disorders
- Pathologic Processes
- Drinking Behavior
- Alcohol-Related Disorders
- Substance-Related Disorders
- Mood Disorders
- Alcohol Drinking
- Alcoholism
- Depression
- Depressive Disorder
- Disease
- Depressive Disorder, Major
- Physiological Effects of Drugs
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Central Nervous System Depressants
- Tranquilizing Agents
- Psychotropic Drugs
- Serotonin Agents
- Antidepressive Agents
- Serotonin 5-HT2 Receptor Antagonists
- Serotonin Antagonists
- Anti-Anxiety Agents
- Serotonin 5-HT3 Receptor Antagonists
- Histamine H1 Antagonists
- Histamine Antagonists
- Histamine Agents
- Adrenergic alpha-Antagonists
- Adrenergic alpha-2 Receptor Antagonists
- Mirtazapine
Other Study ID Numbers
- R21AA022123 (U.S. NIH Grant/Contract)
- 5R21AA022123-02 (U.S. NIH Grant/Contract)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
No individual subject data will be shared.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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