NCT02185131

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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for phase_2 major-depressive-disorder

Timeline
Completed

Started Sep 2013

Typical duration for phase_2 major-depressive-disorder

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

June 26, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

July 9, 2014

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
10 months until next milestone

Results Posted

Study results publicly available

May 5, 2017

Completed
Last Updated

May 5, 2017

Status Verified

March 1, 2017

Enrollment Period

2.8 years

First QC Date

June 26, 2014

Results QC Date

August 17, 2016

Last Update Submit

March 24, 2017

Conditions

Major Depressive DisorderAlcohol Use Disorder

Keywords

Major Depressive DisorderAlcohol Use Disorder

Outcome Measures

Primary Outcomes (2)

  • Drinks Per Drinking Day

    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

    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

Study Arms (2)

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.

Drug: MirtazapineDrug: 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.

Drug: MirtazapineDrug: Placebo

Interventions

MirtazapineDRUG

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.

Also known as: Remeron
MirtazapinePlacebo
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.

MirtazapinePlacebo

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Western Psychiatric Institute and Clinic

Pittsburgh, Pennsylvania, 15213, United States

Location

Related Publications (2)

  • 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.

    PMID: 23230395BACKGROUND

  • 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.

    PMID: 27327217BACKGROUND

MeSH Terms

Conditions

Depressive Disorder, MajorAlcoholism

Interventions

Mirtazapine

Condition Hierarchy (Ancestors)

Depressive DisorderMood DisordersMental DisordersAlcohol-Related DisordersSubstance-Related DisordersChemically-Induced Disorders

Intervention Hierarchy (Ancestors)

DibenzazepinesHeterocyclic Compounds, 3-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Results Point of Contact

Title
Jack R. Cornelius, M.D., M.P.H.
Organization
University of Pittsburgh
corneliusjr@upmc.edu
412-246-5149

Study Officials

  • Jack R Cornelius, M.D., M.P.H.

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

June 26, 2014

First Posted

July 9, 2014

Study Start

September 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

May 5, 2017

Results First Posted

May 5, 2017

Record last verified: 2017-03

Data Sharing

IPD Sharing
Will not share

No individual subject data will be shared.

Locations

US(1)