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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

Pharmacovigilance in Gerontopsychiatric Patients

Phase 3
Terminated
Conditions
Dementia
Depression
Schizophrenia
Psychosomatic Disorders
Anxiety Disorders
Interventions
First Posted Date
2015-03-02
Last Posted Date
2018-02-28
Lead Sponsor
Hannover Medical School
Target Recruit Count
407
Registration Number
NCT02374567
Locations
🇩🇪

Bezirkskrankenhaus Augsburg, Augsburg, Germany

🇩🇪

Krankenhaus Hedwigshöhe, Berlin, Germany

🇩🇪

Hannover Medical School, Hannover, Germany

and more 2 locations

Adding Mirtazapine to Dexamethasone and Aprepitant for Delayed Emesis

Phase 3
Completed
Conditions
Breast Cancer
Interventions
First Posted Date
2015-01-13
Last Posted Date
2022-04-20
Lead Sponsor
Fudan University
Target Recruit Count
212
Registration Number
NCT02336750
Locations
🇨🇳

Fudan University Cancer Hospital, Shanghai, China

Study to Assess the Effects of Esketamine on Safety of On-road Driving in Healthy Participants

Phase 1
Completed
Conditions
Healthy
Interventions
Drug: Placebo (Matched to Esketamine)
Drug: Placebo (Matched to Mirtazapine)
First Posted Date
2014-08-28
Last Posted Date
2014-12-30
Lead Sponsor
Janssen Research & Development, LLC
Target Recruit Count
26
Registration Number
NCT02228239

The Measurement-based Care in Patients With Depressive Disorder: A Randomized Controlled Trial

Phase 4
Completed
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2014-07-16
Last Posted Date
2014-07-16
Lead Sponsor
Capital Medical University
Target Recruit Count
164
Registration Number
NCT02191124
Locations
🇨🇳

Beijing Anding Hospital, Beijing, Beijing, China

Double-blind Pilot Trial of Mirtazapine for the Treatment of Co-occurring AD/MDD.

Phase 2
Completed
Conditions
Major Depressive Disorder
Alcohol Use Disorder
Interventions
Drug: Placebo
First Posted Date
2014-07-09
Last Posted Date
2017-05-05
Lead Sponsor
University of Pittsburgh
Target Recruit Count
16
Registration Number
NCT02185131
Locations
🇺🇸

Western Psychiatric Institute and Clinic, Pittsburgh, Pennsylvania, United States

Clinical Studies on the Therapeutic Effects of Mirtazapine on Drug-craving in Cocaine Addicts.

Phase 2
Completed
Conditions
Drug-withdrawal.
Drug Abuse
Drug-induced Depressive State
AOD Craving
AODR Depressive State
Interventions
First Posted Date
2013-09-24
Last Posted Date
2013-09-24
Lead Sponsor
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
Target Recruit Count
64
Registration Number
NCT01949571
Locations
🇲🇽

National Institute of Psychiatry, México. Distrito Federal, Distrito Federal, Mexico

Interpersonal Psychotherapy for Treatment Resistant Depression

First Posted Date
2013-07-11
Last Posted Date
2013-07-11
Lead Sponsor
Hospital de Clinicas de Porto Alegre
Target Recruit Count
74
Registration Number
NCT01896349
Locations
🇧🇷

Federal University of Rio Grande do Sul / Hospital de Clínicas de Porto Alegre (HCPA), Porto Alegre, RS, Brazil

Mirtazapine for the Treatment of Methamphetamine Dependence Among MSM (M2.0)

Phase 2
Completed
Conditions
Amphetamine-Related Disorders
Interventions
Drug: Placebo
First Posted Date
2013-06-28
Last Posted Date
2018-03-13
Lead Sponsor
Phillip Coffin, MD, MIA
Target Recruit Count
120
Registration Number
NCT01888835
Locations
🇺🇸

Substance Use Research Unit, San Francisco, California, United States

Mirtazapine for Sleep Disorders in Alzheimer's Disease

Phase 3
Conditions
Alzheimer's Disease
Sleep Disorders
Interventions
First Posted Date
2013-06-04
Last Posted Date
2013-06-04
Lead Sponsor
Brasilia University Hospital
Target Recruit Count
30
Registration Number
NCT01867775
Locations
🇧🇷

Brasilia University, Brasilia, Distrito Federal, Brazil

Algorithm Guided Treatment Strategies for Major Depressive Disorder

Phase 4
Conditions
Major Depressive Disorder
Interventions
First Posted Date
2013-01-10
Last Posted Date
2013-01-10
Lead Sponsor
Shanghai Mental Health Center
Target Recruit Count
1080
Registration Number
NCT01764867
Locations
🇨🇳

Shanghai Mental Health Center, Shanghai, China

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