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

Novel Pilot Study to Treat Symptoms of IBS with Diarrhea Using Combination Therapy of a Low-FODMAP Diet and a Neuromodulator

Early Phase 1

Recruiting

Conditions: IBS - Irritable Bowel Syndrome
Diarrhea

Interventions: Drug: Mirtazapine
Other: Placebo

First Posted Date: 2024-11-12

Last Posted Date: 2025-01-22

Lead Sponsor: Mayo Clinic

Target Recruit Count: 20

Registration Number: NCT06684470

Locations: 🇺🇸
Mayo Clinic, Jacksonville, Florida, United States

Prophylactic Mirtazapine and Different Doses of Intrathecal Morphine in Preventing Nausea and Vomiting After Cesarean Section

Not Applicable

Completed

Conditions: Prophylactic
Mirtazapine
Intrathecal
Morphine
Nausea
Vomiting

Interventions: Drug: Mirtazapine + Bupivacaine + Morphine
Drug: Placebo + Bupivacaine + Morphine
Drug: Placebo+ Bupivacaine + Morphine

First Posted Date: 2024-11-08

Last Posted Date: 2024-11-08

Lead Sponsor: Kafrelsheikh University

Target Recruit Count: 120

Registration Number: NCT06681805

Locations: 🇪🇬
Kafrelsheikh University, Kafr Ash Shaykh, Kafrelsheikh, Egypt

Evaluating the Effect of Mirtazapine on Anxiety in Parkinson's Disease Patients

Phase 2

Recruiting

Conditions: Parkinson Disease
Anxiety

Interventions: Drug: Mirtazapine 15 MG
Drug: Placebo

First Posted Date: 2024-07-31

Last Posted Date: 2025-05-21

Lead Sponsor: Leila Dargahi. PharmD PhD

Target Recruit Count: 64

Registration Number: NCT06530290

Locations: 🇮🇷
Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital, Tehran, Iran, Islamic Republic of

Mirtazapine for Acute and Chronic Post Mastectomy Pain

Early Phase 1

Active, not recruiting

Conditions: Breast Cancer

Interventions: Drug: Mirtazapine 30 MG
Drug: Placebo

First Posted Date: 2024-07-12

Last Posted Date: 2025-01-30

Lead Sponsor: Assiut University

Target Recruit Count: 62

Registration Number: NCT06499090

Locations: 🇪🇬
south Egypt Cancer Institute Assiut University, Assiut, Egypt

Mirtazapine for the Treatment of Methamphetamine Use in Opioid Use Disorder Patients Receiving Medication Assisted Treatment

Phase 2

Recruiting

Conditions: Stimulant Use Disorder

Interventions: Drug: Placebo
Drug: Mirtazapine

First Posted Date: 2024-03-21

Last Posted Date: 2025-03-04

Lead Sponsor: Washington State University

Target Recruit Count: 60

Registration Number: NCT06323837

Locations: 🇺🇸
Spokane Treatment Center, Spokane, Washington, United States

Trial of Mirtazapine for Depression in IBD

Phase 2

Recruiting

Conditions: Major Depressive Disorder
Inflammatory Bowel Diseases

Interventions: Drug: Placebo
Drug: Mirtazapine

First Posted Date: 2024-03-13

Last Posted Date: 2024-08-22

Lead Sponsor: King's College London

Target Recruit Count: 76

Registration Number: NCT06309472

Locations: 🇬🇧
Imperial College Healthcare NHS Trust, London, United Kingdom
🇬🇧
King's College Hospital NHS Foundation Trust, London, United Kingdom
🇬🇧
St Mark's Hospital, London, United Kingdom

and more 1 locations