Mirtazapine

Generic Name: Mirtazapine

Brand Names: Remeron

Drug Type: Small Molecule

Chemical Formula: C_₁₇H_₁₉N_₃

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

Clinical Trials

Pilot Study to Evaluate Individualized Choice of Antidepressants in Patients With Cancer

Early Phase 1

Completed

Conditions: Neoplasms
Major Depressive Disorder

Interventions: Drug: Mirtazapine
Drug: Citalopram

First Posted Date: 2012-11-12

Last Posted Date: 2017-03-13

Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

Target Recruit Count: 21

Registration Number: NCT01725048

Locations: 🇺🇸
University of North Carolina Hospital, Chapel Hill, North Carolina, United States

LEPR Polymorphism Weight Gain by Mirtazapine in Late Life Depression

Phase 4

Completed

Conditions: Major Depressive Disorder

Interventions: Drug: Mirtazapine

First Posted Date: 2012-05-17

Last Posted Date: 2016-04-21

Lead Sponsor: Lawson Health Research Institute

Target Recruit Count: 19

Registration Number: NCT01601002

Locations: 🇨🇦
London Health Sciences Centre, London, Ontario, Canada

Mirtazapine Plus Gemcitabine Versus Gemcitabine in Metastasis Pancreatic Cancer

Phase 2

Withdrawn

Conditions: Pancreatic Cancer

Interventions: Drug: Gemcitabine, placebo
Drug: Mirtazapine plus gemcitabine

First Posted Date: 2012-05-15

Last Posted Date: 2015-09-28

Lead Sponsor: Tianjin Medical University Cancer Institute and Hospital

Registration Number: NCT01598584

Locations: 🇨🇳
TianjinCIH, Tianjin, Tianjin, China

Mirtazapine in Alzheimer-associated Weight Loss

Completed

Conditions: Alzheimer's Disease
Weight Loss
Mixed Dementia
Dementia

First Posted Date: 2012-01-06

Last Posted Date: 2012-01-06

Lead Sponsor: Brugmann University Hospital

Target Recruit Count: 22

Registration Number: NCT01505504

Locations: 🇧🇪
CHU Brugmann, Brussels, Belgium

Megestrol Acetate With or Without Mirtazapine in Treating Cancer Patients With Weight Loss or Loss of Appetite

Phase 2

Withdrawn

Conditions: Anorexia

Interventions: Drug: Megestrol Acetate
Drug: Mirtazapine

First Posted Date: 2011-12-29

Last Posted Date: 2014-02-03

Lead Sponsor: Washington University School of Medicine

Registration Number: NCT01501396

Efficacy Study of Mirtazapine to Treat Interferon-related Depression During Antiviral Therapy for Hepatitis C

Phase 4

Terminated

Conditions: Depression

Interventions: Other: Supportive psychotherapy
Drug: Mirtazapine

First Posted Date: 2011-11-06

Last Posted Date: 2020-03-20

Lead Sponsor: Seoul National University Boramae Hospital

Target Recruit Count: 5

Registration Number: NCT01465919

Locations: 🇰🇷
SMG-SNU Boramae Medical Center, Seoul, Korea, Republic of

Effectiveness Study of Mirtazapine Combined With Paroxetine in Major Depressive Patients Without Early Improvement

Phase 4

Completed

Conditions: Major Depression

Interventions: Drug: mirtazapine
Drug: paroxetine 20mg QD

First Posted Date: 2011-10-25

Last Posted Date: 2017-08-31

Lead Sponsor: Capital Medical University

Target Recruit Count: 525

Registration Number: NCT01458626

Locations: 🇨🇳
Beijing Anding Hospital, Beijing, Beijing, China

Mirtazapine Treatment of Anxiety in Children and Adolescents With Pervasive Developmental Disorders

Phase 3

Completed

Conditions: Autism Spectrum Disorders

Interventions: Drug: Placebo
Drug: Mirtazapine

First Posted Date: 2011-02-24

Last Posted Date: 2018-11-07

Lead Sponsor: Massachusetts General Hospital

Target Recruit Count: 30

Registration Number: NCT01302964

Locations: 🇺🇸
Riley Child and Adolescent Psychiatry Clinic Riley Hospital, Indianapolis, Indiana, United States
🇺🇸
Lurie Center -MassGeneral Hospital, Lexington, Massachusetts, United States