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

Non-interventional, Retrospective Cohort Study to Explore Antidepressant Treatment in Korea

Completed

Conditions: Major Depression

Interventions: Drug: Desvenlafaxine
Drug: Escitalopram
Drug: Paroxetine
Drug: Fluoxetine
Drug: Mirtazapine
Drug: Duloxetine
Drug: Sertraline
Drug: Venlafaxine
Drug: Tianeptine
Drug: Vortioxetine
Drug: Bupropion

First Posted Date: 2020-06-24

Last Posted Date: 2024-12-09

Lead Sponsor: Pfizer

Target Recruit Count: 370212

Registration Number: NCT04446039

Locations: 🇰🇷
Pfizer, Seoul, Korea, Republic of

Nutrition and Pharmacological Algorithm for Oncology Patients Study

Phase 4

Terminated

Conditions: Quality of Life
Pancreatic Cancer
Nutrition Poor
Head and Neck Cancer
Lung Cancer
Oncologic Complications

Interventions: Behavioral: Nutrition Intervention
Drug: Dexamethasone
Drug: Dronabinol
Drug: Mirtazapine

First Posted Date: 2019-11-07

Last Posted Date: 2022-11-16

Lead Sponsor: Montefiore Medical Center

Target Recruit Count: 1

Registration Number: NCT04155008

Locations: 🇺🇸
Montefiore Hospital, Bronx, New York, United States

Effects of Aprepitant/Dexamethasone Versus Mertazepine /Dexamethasone on Postoperative Nausea and Vomiting

Phase 4

Completed

Conditions: Nausea and Vomiting, Postoperative

Interventions: Drug: Aprepitant and Dexamethasone
Drug: Mirtazapine and Dexamethasone
Drug: Dexamethasone

First Posted Date: 2019-07-09

Last Posted Date: 2020-01-03

Lead Sponsor: Ain Shams University

Target Recruit Count: 90

Registration Number: NCT04013386

Locations: 🇪🇬
Ain-Shams University Hospitals, Cairo, Egypt

Pilot Study of Mirtazapine for the Dual Tx of Depression and CINV in High-Grade Glioma Pts on TMZ

Phase 2

Active, not recruiting

Conditions: Glioma of Brain

Interventions: Drug: Mirtazapine (Remeron)

First Posted Date: 2019-05-02

Last Posted Date: 2024-05-14

Lead Sponsor: University of California, Irvine

Target Recruit Count: 120

Registration Number: NCT03935685

Locations: 🇺🇸
UC Irvine Health/Chao Family Comprehensive Cancer Center, Orange, California, United States

5HT2CR Balance in Brain Connectivity in Cocaine Dependence

Phase 1

Completed

Conditions: Cocaine Dependence

Interventions: Drug: Mirtazapine 15 MG Oral Tablet

First Posted Date: 2019-04-19

Last Posted Date: 2021-11-22

Lead Sponsor: Virginia Commonwealth University

Target Recruit Count: 90

Registration Number: NCT03921151

Locations: 🇺🇸
Virginia Commonwealth University, Richmond, Virginia, United States

A Study of Esketamine Nasal Spray Plus a New Standard-of-care Oral Antidepressant or Placebo Nasal Spray Plus a New Standard-of-care Oral Antidepressant in Adult and Elderly Participants With Treatment-resistant Depression

Phase 3

Withdrawn

Conditions: Depressive Disorder, Treatment-Resistant

Interventions: Drug: Esketamine 28 mg
Drug: Placebo
Drug: Esketamine 56 mg
Drug: Esketamine 84 mg
Drug: Escitalopram
Drug: Sertraline
Drug: Duloxetine
Drug: Mirtazapine
Drug: Trazodone Prolonged Release
Drug: Agomelatine
Drug: Bupropion

First Posted Date: 2019-02-25

Last Posted Date: 2025-04-27

Lead Sponsor: Janssen-Cilag International NV

Registration Number: NCT03852160

Validating the Effect og Ondansetron and Mirtazapine in Treating Hyperemesis Gravidarum

Phase 2

Terminated

Conditions: Hyperemesis Gravidarum
Vomiting of Pregnancy
Nausea Gravidarum

Interventions: Drug: Placebo
Drug: Mirtazapine
Drug: Ondansetron

First Posted Date: 2018-12-24

Last Posted Date: 2023-01-30

Lead Sponsor: Nordsjaellands Hospital

Target Recruit Count: 58

Registration Number: NCT03785691

Locations: 🇩🇰
Department of Gynaecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark
🇩🇰
Department of Gynaecology and Obstetrics, Rigshospitalet, Copenhagen, Denmark
🇩🇰
Department of Gynaecology and Obstetrics, Herlev Hospital, Herlev, Denmark

and more 4 locations