MedPath

Mirtazapine

Generic Name
Mirtazapine
Brand Names
Remeron
Drug Type
Small Molecule
Chemical Formula
C17H19N3
CAS Number
85650-52-8
Unique Ingredient Identifier
A051Q2099Q
Background

Mirtazapine is a tetracyclic piperazino-azepine antidepressant agent that was initially approved for the treatment of major depressive disorder (MDD) in the Netherlands in 1994. This drug was first manufactured by Organon Inc., and received FDA approval in 1997 for the treatment of major depressive disorder. The effects of this drug may be observed as early as 1 week after beginning therapy.

In addition to its beneficial effects in depression, mirtazapine has been reported to be efficacious in the off-label management of various other conditions. It may improve the symptoms of neurological disorders, reverse weight loss caused by medical conditions, improve sleep, and prevent nausea and vomiting after surgery.

Indication

This drug is indicated for the treatment of major depressive disorder and its associated symptoms.

Mirtazapine has been used off-label for a variety of conditions including panic disorder, generalized anxiety disorder, dysthymia, tension headaches, hot flushes, post-traumatic stress disorder (PTSD), sleep disorders, substance abuse disorders, and sexual disorders, among others.

Associated Conditions
Cancer Pain, Depression, Fibromyalgia, Generalized Anxiety Disorder, Hot Flashes, Insomnia, Major Depressive Disorder (MDD), Obsessive Compulsive Disorder (OCD), Panic Disorder, Persistent Depressive Disorder (Dysthymia), Post Operative Nausea and Vomiting (PONV), Poststroke depression, Sleep disorders and disturbances, Substance Abuse Disorders, Tension Headache

Combined Mirtazapine and SSRI Treatment of PTSD: A Placebo-Controlled Trial

Phase 4
Completed
Conditions
Posttraumatic Stress Disorder
Interventions
First Posted Date
2010-08-10
Last Posted Date
2016-04-08
Lead Sponsor
Research Foundation for Mental Hygiene, Inc.
Target Recruit Count
38
Registration Number
NCT01178671
Locations
🇺🇸

Anxiety Disorders Clinic, New York State Psychiatric Institute, New York, New York, United States

A Study of Quetiapine and Mirtazapine for the Treatment of Alcohol Dependency

Phase 2
Completed
Conditions
Alcohol Dependence
Interventions
First Posted Date
2010-07-20
Last Posted Date
2018-04-09
Lead Sponsor
Dartmouth-Hitchcock Medical Center
Target Recruit Count
20
Registration Number
NCT01165541
Locations
🇺🇸

Dartmouth Medical School Department of Psychiatry's Addition Research Center, Bedford, New Hampshire, United States

🇺🇸

Dartmouth Medical School Department of Psychiatry's Addiction Research Center, Hanover, New Hampshire, United States

Strategic Use of New Generation Antidepressants for Depression

Phase 4
Completed
Conditions
Unipolar Major Depressive Episode
Interventions
First Posted Date
2010-04-23
Last Posted Date
2016-10-03
Lead Sponsor
Kyoto University
Target Recruit Count
2011
Registration Number
NCT01109693
Locations
🇯🇵

Nagoya City University Hospital, Nagoya, Aichi, Japan

🇯🇵

Kochi Medical School Hospital, Nangoku, Kochi, Japan

Pharmacogenetic Study of Mirtazapine Response in Depressed Patients

Not Applicable
Conditions
Depression
Interventions
First Posted Date
2009-12-25
Last Posted Date
2015-12-31
Lead Sponsor
Samsung Medical Center
Target Recruit Count
100
Registration Number
NCT01039740
Locations
🇰🇷

Samsung Medical Center, Kangnam, Seoul, Korea, Republic of

Mirtazapine Reduces ICD Shocks in ICD Patients With Depression and Anxiety

Not Applicable
Completed
Conditions
Depression
Anxiety
Interventions
First Posted Date
2009-08-18
Last Posted Date
2009-08-18
Lead Sponsor
Universidad Nacional de Rosario
Target Recruit Count
40
Registration Number
NCT00960830
Locations
🇦🇷

Cl Sn Nicol, San Nicolas, Bs As, Argentina

Study of Indoleamine 2,3-dioxygenase Activity, Serum Levels of Cytokines, BDNF, BH4 and Mirtazapine Efficacy in Fibromyalgia Syndrome

Phase 2
Completed
Conditions
Fibromyalgia Syndrome
Interventions
Drug: placebo
First Posted Date
2009-06-12
Last Posted Date
2012-07-25
Lead Sponsor
Mahidol University
Target Recruit Count
80
Registration Number
NCT00919295
Locations
🇹🇭

Siriraj Hospital, Mahidol University, Bangkoknoi, Bangkok, Thailand

Short-term Metabolic Effects of Mirtazapine in Healthy Subjects

Phase 1
Completed
Conditions
Healthy
Interventions
First Posted Date
2009-04-09
Last Posted Date
2010-09-16
Lead Sponsor
Max-Planck-Institute of Psychiatry
Target Recruit Count
12
Registration Number
NCT00878540
Locations
🇩🇪

Max Planck Institue of Psychiatry, Munich, Germany

The Effects of Mirtazapine Versus Placebo on Alcohol Consumption in Male Alcohol High Consumers

Phase 2
Completed
Conditions
Alcohol Dependence
Interventions
Drug: placebo
First Posted Date
2009-04-02
Last Posted Date
2009-04-02
Lead Sponsor
Sahlgrenska University Hospital, Sweden
Target Recruit Count
59
Registration Number
NCT00874003
Locations
🇸🇪

Addiction Biology Unit, Gothenburg, Sweden

A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Fasting Conditions

First Posted Date
2009-03-19
Last Posted Date
2010-08-17
Lead Sponsor
Actavis Inc.
Target Recruit Count
32
Registration Number
NCT00865696
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

A Relative Bioavailability Study of Mirtazapine 15 mg Tablets Under Non-fasting Conditions

First Posted Date
2009-03-19
Last Posted Date
2010-08-17
Lead Sponsor
Actavis Inc.
Target Recruit Count
24
Registration Number
NCT00865384
Locations
🇺🇸

PRACS Institute, Ltd., Fargo, North Dakota, United States

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