Major Depressive DisorderPhase 2PT-MADNCT02185131
Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
A Phase 2 study testing Mirtazapine in people with Major Depressive Disorder and Alcohol Use Disorder, run by University of Pittsburgh at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Major Depressive Disorder, Alcohol Use Disorder
- What is being tested?
- Mirtazapine
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2013to Jul 2016
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Western Psychiatric Institute and Clinic
Pittsburgh, Pennsylvania, 15213
About this study
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.
Read the 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.
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Being tested
- Mirtazapine, Placebo
- Keywords
- Major Depressive Disorder, Alcohol Use Disorder
- Medical subject headings
- Depressive Disorder, Major, Alcoholism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirtazapineDrug
Also called Remeron
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.
PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Mirtazapine | Active comparator | 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. Receives: Drug: Mirtazapine; Drug: Placebo |
| Placebo | Active comparator | 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. Receives: Drug: Mirtazapine; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Drinks Per Drinking Day
Level of drinking, as indicated by the number of drinks per day as recorded on the Timeline Follow-Back calendar.
Measured: 12 Weeks
Level of Depressive Symptoms
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.
Measured: 12 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startSep 2013
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Responsible party
- Principal investigator, Jack Cornelius, University of Pittsburgh
- Investigators
- Jack R Cornelius, M.D., M.P.H., Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185131
- Sponsor's protocol ID
- R21AA022123
- Other IDs
- 5R21AA022123-02
- Acronym
- PT-MAD
- Status last verified
- Mar 2017
- First submitted
- 26 Jun 2014
- Last updated
- 5 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No: No individual subject data will be shared.
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. doi: 10.1080/15504263.2012.696527. Epub 2012 Aug 8.
PubMed 23230395Cornelius 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.
PubMed 27327217
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.
- ClinicalTrials.gov ID
- NCT02185131
- Acronym / sponsor ID
- PT-MAD / R21AA022123
- Conditions
- Major Depressive Disorder, Alcohol Use Disorder
- Keywords
- Major Depressive Disorder, Alcohol Use Disorder
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Collaborators
- National Institute on Alcohol Abuse and Alcoholism (NIAAA)
- Study start
- Sep 2013
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 9 Jul 2014 (estimated)
- Results
- Posted 5 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mirtazapine | Active comparator | Drug: Mirtazapine, Drug: PlaceboGelatin 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. |
| Placebo | Active comparator | Drug: Mirtazapine, Drug: PlaceboGelatin 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. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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)
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MirtazapineAlso: RemeronGelatin 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. | Drug | Mirtazapine, Placebo |
| PlaceboGelatin 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. | Drug | Mirtazapine, Placebo |
Primary outcome
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.
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23230395Cornelius 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.
- Background: PubMed 27327217Cornelius 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.
- Individual participant dataSharing planned: No. No individual subject data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jack R Cornelius, M.D., M.P.H. principal investigator
University of Pittsburgh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Mirtazapine in people with Major Depressive Disorder and Alcohol Use Disorder, run by University of Pittsburgh at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Drinks Per Drinking Day (time frame: 12 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02185131, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2017.