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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

Mirtazapine for Chronic Insomnia in Older Adults

Phase 1
Completed
Conditions
Chronic Insomnia
Interventions
Drug: Placebo oral tablet once daily at bedtime
First Posted Date
2022-02-21
Last Posted Date
2024-08-12
Lead Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Target Recruit Count
60
Registration Number
NCT05247697
Locations
🇨🇦

Centre Hospitalier de l'Université de Montréal, Montreal, Quebec, Canada

Comparing Olanzapine and Mirtazapine in the Improvement of Unintentional Weight Loss for Patients With Advanced Stage Cancer

Phase 2
Conditions
Anorexia Nervosa with Significantly Low Body Weight
Interventions
First Posted Date
2021-12-28
Last Posted Date
2022-07-26
Lead Sponsor
Englewood Hospital and Medical Center
Target Recruit Count
170
Registration Number
NCT05170919
Locations
🇺🇸

Englewood Health, Englewood, New Jersey, United States

Mirtazapine vs Sumatriptan in the Treatment of Postdural Puncture Headache

Phase 4
Completed
Conditions
Headache
Interventions
First Posted Date
2021-11-05
Last Posted Date
2024-01-22
Lead Sponsor
Ain Shams University
Target Recruit Count
210
Registration Number
NCT05108688
Locations
🇪🇬

Ain-Shams University Hospitals, Cairo, Egypt

Emergence Agitation After Nasal Surgery: a Randomized Controlled Comparison Between Melatonin and Mirtazapine

Phase 4
Completed
Conditions
Agitation
Interventions
First Posted Date
2021-06-01
Last Posted Date
2022-04-15
Lead Sponsor
Ain Shams University
Target Recruit Count
165
Registration Number
NCT04908605
Locations
🇪🇬

Ain-Shams University Hospitals, Cairo, Egypt

Role of Mirtazapine in Ameliorating Sleep Disordered Breathing

Phase 2
Completed
Conditions
Spinal Cord Injuries
Sleep Disordered Breathing
Interventions
Drug: Placebo
First Posted Date
2021-03-16
Last Posted Date
2021-06-15
Lead Sponsor
Wayne State University
Target Recruit Count
18
Registration Number
NCT04799782

Mirtazapine in Cancer-related Poly-symptomatology

Phase 3
Terminated
Conditions
Cancer
Neoplasm Metastasis
Neoplasms
Interventions
First Posted Date
2021-02-21
Last Posted Date
2023-06-08
Lead Sponsor
Hospices Civils de Lyon
Target Recruit Count
1
Registration Number
NCT04763135
Locations
🇫🇷

Hôpitaux universitaires de Strasbourg, Strasbourg, France

🇫🇷

Centre Hospitalier Lyon Sud, Pierre-Bénite, France

🇫🇷

Centre Hospitalier Universitaire de Clermont-Ferrand, Cébazat, France

and more 8 locations

Effect of Mirtazapine Versus Placebo in Patients With Non-small Cell Lung Cancer and Anorexia

Not Applicable
Completed
Conditions
Anorexia
Non-small Cell Lung Cancer
Interventions
Drug: Placebo Oral Tablet
First Posted Date
2021-02-10
Last Posted Date
2023-04-27
Lead Sponsor
Instituto Nacional de Cancerologia de Mexico
Target Recruit Count
86
Registration Number
NCT04748523
Locations
🇲🇽

Instituto Nacional de Cancerologia, Mexico City, Mexico

Improving Sleep After TKA Using Mirtazapine and Quetiapine

Not Applicable
Not yet recruiting
Conditions
Osteo Arthritis Knee
Insomnia
Interventions
First Posted Date
2021-01-28
Last Posted Date
2023-06-02
Lead Sponsor
St. Anna Ziekenhuis, Geldrop, Netherlands
Target Recruit Count
165
Registration Number
NCT04728581
Locations
🇳🇱

St. Anna hospital, Geldrop, Netherlands

🇳🇱

Knowledge Center for Orthopedic Surgery, St. Anna hospital, Geldrop, Netherlands

Mirtazapine and Methamphetamine Drug-drug Interaction Study

Phase 1
Recruiting
Conditions
Methamphetamine Use Disorder
Drug Interaction
Cardiovascular Abnormalities
Interventions
First Posted Date
2020-11-04
Last Posted Date
2023-11-22
Lead Sponsor
San Francisco Department of Public Health
Target Recruit Count
24
Registration Number
NCT04614584
Locations
🇺🇸

UCLA Medical Center, Los Angeles, California, United States

🇺🇸

San Francisco Department of Public Health, San Francisco, California, United States

🇺🇸

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

Mirtazapine Versus Dexamethasone in Preventing Postoperative Nausea and Vomiting

Early Phase 1
Completed
Conditions
Post Operative Nausea and Vomiting
Interventions
First Posted Date
2020-09-14
Last Posted Date
2024-10-08
Lead Sponsor
Ain Shams University
Target Recruit Count
90
Registration Number
NCT04547842
Locations
🇪🇬

Ain Shams University, Cairo, Abassia, Egypt

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