Clinical Trials

Multiple clinical trials across early to late phases have evaluated mirtazapine's safety, drug interactions, and efficacy in treating hyperemesis gravidarum, methamphetamine dependence, brain gliomas, fibromyalgia, and cancer-related anorexia. Sponsored by academic institutions, public health organizations, and medical centers—including Northwestern University and the San Francisco Department of Public Health—these studies encompass various recruitment statuses, including active recruiting, enrolling by invitation, completed, terminated, and withdrawn protocols.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03935685 ACTIVE_NOT_RECRUITING
Glioma of Brain
University of California, Irvine
 2019-02-26 PHASE2
NCT00488072 ACTIVE_NOT_RECRUITING
Advanced Cancer; Anorexia; Weight Loss; Insomnia
M.D. Anderson Cancer Center
 2007-01-08 PHASE2
NCT06684470 RECRUITING
IBS - Irritable Bowel Syndrome; Diarrhea
Mayo Clinic
 2024-12-19 EARLY_PHASE1
NCT06323837 RECRUITING
Stimulant Use Disorder
Washington State University
 2024-06-17 PHASE2
NCT05170919 ENROLLING_BY_INVITATION
Anorexia Nervosa with Significantly Low Body Weight
Englewood Hospital and Medical Center
 2022-01-20 PHASE2
NCT07430046 RECRUITING
RETT Syndrome With Proven MECP2 Mutation
University of Trieste
 2025-07-09 PHASE2
NCT04728581 NOT_YET_RECRUITING
Osteo Arthritis Knee; Insomnia
St. Anna Ziekenhuis, Geldrop, Netherlands
 2024-01-01
NCT06530290 UNKNOWN
Parkinson Disease; Anxiety
Leila Dargahi. PharmD PhD
 2022-06-01 PHASE2
NCT06499090 COMPLETED
Breast Cancer
Assiut University
 2024-03-01 EARLY_PHASE1
NCT06309472 COMPLETED
Major Depressive Disorder; Inflammatory Bowel Diseases
King's College London
 2024-05-07 PHASE2
NCT06213948 UNKNOWN
Functional Disorder of Stomach; Healthy
Universiti Sains Malaysia
 2021-08-01 PHASE1
NCT06681805 COMPLETED
Prophylactic; Mirtazapine; Intrathecal; Morphine; Nausea; Vomiting
Kafrelsheikh University
 2023-01-01
NCT05247697 COMPLETED
Chronic Insomnia
Centre hospitalier de l'Université de Montréal (CHUM)
 2022-10-01 PHASE1
NCT04614584 COMPLETED
Methamphetamine Use Disorder; Drug Interaction; Cardiovascular Abnormalities
San Francisco Department of Public Health
 2021-05-03 PHASE1
NCT05978219 COMPLETED
Major Depressive Disorder With Insomnia
National Institute of Mental Health, Dhaka
 2023-05-25 PHASE4
NCT05108688 COMPLETED
Headache
Ain Shams University
 2021-11-15 PHASE4
NCT05452174 WITHDRAWN
Pregnancy; Severe Nausea and Vomiting; Hyperemesis Gravidarum
Northwestern University
 2022-06-13 PHASE1; PHASE2
NCT04547842 COMPLETED
Post Operative Nausea and Vomiting
Ain Shams University
 2020-09-01 EARLY_PHASE1
NCT05380479 UNKNOWN
Anorexia
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
 2022-06-01 PHASE2
NCT03785691 TERMINATED
Hyperemesis Gravidarum; Nausea Gravidarum; Vomiting of Pregnancy
Nordsjaellands Hospital
 2019-03-01 PHASE2
NCT04748523 COMPLETED
Anorexia; Non-small Cell Lung Cancer
Instituto Nacional de Cancerologia de Mexico
 2018-08-29
NCT05452174 Terminated
Pregnancy|Severe Nausea and Vomiting|Hyperemesis Gravidarum
Northwestern University|Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
 2022-06-13 Phase 1|Phase 2
NCT04908605 COMPLETED
Agitation
Ain Shams University
 2021-06-15 PHASE4
NCT03283488 COMPLETED
Cachexia; Cancer; Anorexia
University of Sao Paulo
 2019-03-26 PHASE2
NCT03148522 UNKNOWN
Diagnosis and Treatment of Depression
Peking University
 2017-06-01
NCT04763135 TERMINATED
Cancer; Neoplasms; Neoplasm Metastasis
Hospices Civils de Lyon
 2021-12-15 PHASE3
NCT02336750 COMPLETED
Breast Cancer
Fudan University
 2014-12 PHASE3
NCT03852160 WITHDRAWN
Depressive Disorder, Treatment-Resistant
Janssen-Cilag International NV
 2019-12-01 PHASE3
NCT04614584 Recruiting
Methamphetamine Use Disorder|Drug Interaction|Cardiovascular Abnormalities
San Francisco Department of Public Health|University of California Los Angeles
 2021-07-12 Phase 1
NCT04155008 TERMINATED
Oncologic Complications; Quality of Life; Nutrition Poor; Head and Neck Cancer; Lung Cancer; Pancreatic Cancer
Montefiore Medical Center
 2021-03-01 PHASE4
NCT03031184 COMPLETED
Dementia
University of Sussex
 2017-01 PHASE3
NCT02711215 UNKNOWN
Major Depressive Disorder
Medical University of Vienna
 2015-05 PHASE4
NCT04013386 COMPLETED
Nausea and Vomiting, Postoperative
Ain Shams University
 2019-07-15 PHASE4
NCT03219008 UNKNOWN
Depressive Disorder
Shanghai Mental Health Center
 2017-08-01 PHASE4
NCT02655354 COMPLETED
Posttraumatic Stress Disorder; Depression; Alcohol-Related Disorders; Suicidal Ideation; Substance-Related Disorders; Mild Cognitive Impairment; Quality of Life; Pain; Wounds and Injury; Brain Injuries; Chronic Disease
University of Washington
 2015-10
NCT03254173 COMPLETED
Advanced Cancer; Cancer Associated Anorexia - Cachexia
Catherine Naseef Hunter
 2018-03-26 PHASE2; PHASE3
NCT04799782 COMPLETED
Spinal Cord Injuries; Sleep Disordered Breathing
Wayne State University
 2017-01 PHASE2
NCT03785691 Terminated
Hyperemesis Gravidarum|Nausea Gravidarum|Vomiting of Pregnancy
Nordsjaellands Hospital|Bispebjerg Hospital|Aarhus University Hospital|Herlev and Gentofte Hospital|Hvidovre University Hospital|Odense University Hospital|Rigshospitalet Denmark|Regionernes Medicinpulje|Kolding Sygehus
 2019-03-01 Phase 2
NCT03935685 Recruiting
Glioma of Brain
University of California Irvine
 2019-02-26 Phase 2
NCT03921151 COMPLETED
Cocaine Dependence
Virginia Commonwealth University
 2014-05-13 PHASE1; PHASE2
NCT03675555 COMPLETED
Shivering
Ain Shams University
 2018-03-01 PHASE4
NCT03679052 COMPLETED
Shivering
Ain Shams University
 2018-03-01 PHASE4
NCT02650544 UNKNOWN
Carcinoma, Non-Small-Cell Lung; Depression
Sun Yat-sen University
 2015-12 PHASE2
NCT01039740 UNKNOWN
Depression
Samsung Medical Center
 2003-02
NCT01465919 TERMINATED
Depression
Seoul National University Boramae Hospital
 2011-08 PHASE4
NCT01302964 COMPLETED
Autism Spectrum Disorders
Massachusetts General Hospital
 2010-08 PHASE3
NCT01888835 COMPLETED
Amphetamine-Related Disorders
Phillip Coffin, MD, MIA
 2013-08 PHASE2
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02541526 UNKNOWN
Heroin Dependence; Amphetamine Dependence
Universiti Sains Malaysia
 2013-05 PHASE3
NCT02646449 COMPLETED
Major Depressive Disorder; Alcohol Use Disorder
University of Pittsburgh
 2015-06 PHASE2
NCT01458626 COMPLETED
Major Depression
Capital Medical University
 2012-11-14 PHASE4
NCT02185131 COMPLETED
Major Depressive Disorder; Alcohol Use Disorder
University of Pittsburgh
 2013-09 PHASE2
NCT01598584 WITHDRAWN
Pancreatic Cancer
Tianjin Medical University Cancer Institute and Hospital
 2012-06 PHASE2; PHASE3
NCT01601002 COMPLETED
Major Depressive Disorder
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
 2012-06 PHASE4
NCT01109693 COMPLETED
Unipolar Major Depressive Episode
Kyoto University
 2010-12 PHASE4
NCT01501396 WITHDRAWN
Anorexia
Washington University School of Medicine
 2013-09 PHASE2
NCT00926835 TERMINATED
Major Depressive Disorder
Ministry of Health & Welfare, Korea
 2009-05 PHASE4
NCT02228239 COMPLETED
Healthy
Janssen Research & Development, LLC
 2014-09 PHASE1
NCT01764867 UNKNOWN
Major Depressive Disorder
Shanghai Mental Health Center
 2012-06 PHASE4
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT01178671 COMPLETED
Posttraumatic Stress Disorder
Research Foundation for Mental Hygiene, Inc.
 2010-07 PHASE4
NCT01867775 UNKNOWN
Alzheimer's Disease; Sleep Disorders
Brasilia University Hospital
 2012-05 PHASE3
NCT01263080 COMPLETED
Schizophrenia
Capital Medical University
 2010-11 PHASE4
NCT00249444 COMPLETED
Cocaine Dependence; Depression
New York State Psychiatric Institute
 2006-05 PHASE2
NCT02191124 COMPLETED
Major Depressive Disorder
Capital Medical University
 2011-06 PHASE4
NCT01165541 COMPLETED
Alcohol Dependence
Dartmouth-Hitchcock Medical Center
 2010-09 PHASE2
NCT01497548 UNKNOWN
Depression
University of Malaya
 2011-03 PHASE3
NCT01725048 COMPLETED
Major Depressive Disorder; Neoplasms
UNC Lineberger Comprehensive Cancer Center
 2011-01 EARLY_PHASE1
NCT00919295 COMPLETED
Fibromyalgia Syndrome
Mahidol University
 2008-12 PHASE2
NCT01240096 COMPLETED
Functional Dyspepsia
Universitaire Ziekenhuizen KU Leuven
 2006-09-01 PHASE4
NCT01949571 COMPLETED
Drug-withdrawal.; Drug Abuse; Drug-induced Depressive State; AOD Craving; AODR Depressive State
Instituto Nacional de Psiquiatría Dr. Ramón de la Fuente
 2007-01 PHASE2
NCT00302107 COMPLETED
Anxiety; PTSD
US Department of Veterans Affairs
 2006-04 PHASE4
NCT00782405 COMPLETED
Sleep
Technical University of Munich
 2008-10 PHASE3
NCT01119924 COMPLETED
Depression; Pain
Nang Kuang Pharmaceutical Co., Ltd.
 2009-12 PHASE4
NCT00832520 TERMINATED
Advanced Cancer
New Mexico Cancer Research Alliance
 2008-11 PHASE2
NCT00878540 COMPLETED
Healthy
Max-Planck-Institute of Psychiatry
 2008-09 PHASE1
NCT00750919 TERMINATED
Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorders, Intrinsic
Merck Sharp & Dohme LLC
 2008-10-07 PHASE3
NCT00497081 COMPLETED
Substance Abuse; HIV Infections
San Francisco Department of Public Health
 2007-05 PHASE2
NCT00561574 COMPLETED
Sleep Initiation and Maintenance Disorder; Elderly; Mental Disorder; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic
Merck Sharp & Dohme LLC
 2008-01-09 PHASE3
NCT00561821 COMPLETED
Insomnia; Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders
Merck Sharp & Dohme LLC
 2007-11-20 PHASE3
NCT00600145 WITHDRAWN
Amphetamine Dependence
University of Virginia
 2007-09
NCT00150839 COMPLETED
Depressive Disorder, Major
University of Erlangen-Nürnberg Medical School
 2006-03 PHASE4
NCT00631657 COMPLETED
Sleep Initiation and Maintenance Disorders; Mental Disorders; Dyssomnias; Sleep Disorders; Sleep Disorder, Intrinsic
Merck Sharp & Dohme LLC
 2008-03-04 PHASE3
NCT00590863 COMPLETED
Major Depressive Disorder
National Institute of Mental Health (NIMH)
 2008-03 PHASE4
NCT00322309 COMPLETED
Cocaine Dependence; Depression
Boston University
 2005-09 PHASE2
NCT00482612 COMPLETED
Insomnia
Merck Sharp & Dohme LLC
 2006-12-07 PHASE3
NCT00960830 COMPLETED
Depression; Anxiety
Universidad Nacional de Rosario
 2007-04
NCT00506389 COMPLETED
Insomnia
Merck Sharp & Dohme LLC
 2007-06-06 PHASE3
NCT00874003 COMPLETED
Alcohol Dependence
Sahlgrenska University Hospital
 2004-04 PHASE2
NCT00560833 COMPLETED
Menopause; Vasomotor Symptoms
Merck Sharp & Dohme LLC
 2004-10-15 PHASE3
NCT00535288 COMPLETED
Postmenopausal Symptoms; Menopause; Vasomotor Symptoms
Merck Sharp & Dohme LLC
 2004-09-15 PHASE3
NCT00834197 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2003-07 PHASE1
NCT00835575 COMPLETED
Healthy
Teva Pharmaceuticals USA
 2003-07 PHASE1
NCT00865384 COMPLETED
Healthy
Actavis Inc.
 2001-09 PHASE1
NCT00865696 COMPLETED
Healthy
Actavis Inc.
 2001-09 PHASE1
NCT00080158 COMPLETED
Depression; Suicide, Attempted
New York State Psychiatric Institute
 2004-03 PHASE2; PHASE3
NCT00021528 COMPLETED
Depression
National Institute of Mental Health (NIMH)
 2001-07 PHASE4
NCT00108498 COMPLETED
Obstructive Sleep Apnea
US Department of Veterans Affairs
 2003-10 PHASE1
NCT00385437 COMPLETED
Depression; Excessive Daytime Sleepiness
University Health Network, Toronto
 2003-04 PHASE2
NCT00288782 COMPLETED
Mental Disorders; Mood Disorders; Affective Disorders; Depressive Disorders
University of Aarhus
 2006-02 PHASE4
NCT00177567 COMPLETED
Bipolar Disorder
University of Pittsburgh
 2001-07 PHASE4

(data from https://clinicaltrials.gov, updated on 2025-09-24)

Check the Mirtazapine product page for in-depth specifications, including solubility, stock solutions, MOA, and working concentrations.

Compliance for Clinical Use

Mechanism and Biochemical Profile

Mirtazapine functions as an antagonist at central presynaptic alpha-2 adrenergic and specific serotonergic receptors, thereby enhancing central noradrenergic tone and selectively promoting downstream serotonergic neurotransmission while blocking 5-HT2 and 5-HT3 pathways. This pharmacological activity suppresses emetic signaling and regulates central appetite and mood pathways, directly supporting its clinical evaluation for hyperemesis gravidarum, major depressive disorder, and cancer-associated weight loss.

Appendix RUO and cGMP Quality Standards

Quality Dimension RUO (Research Use Only) cGMP (Current Good Manufacturing Practice)
Clinical Applicability Prohibited in human clinical trials or medical diagnostics. Mandatory for human clinical trials (Phase I–III) and therapies.
Regulatory Status Non-regulated grade; exempt from drug manufacturing laws. Legally enforced by health authorities (e.g., FDA, EMA, NMPA).
Facility Environment Unclassified analytical or research laboratories. Validated Cleanrooms (ISO Class 5–8) with continuous monitoring.
Quality Control Basic purity and activity testing. Rigorous safety release testing (Sterility, Endotoxin, Mycoplasma).
Process Validation Basic equipment calibration; no process validation required. Full qualification (IQ/OQ/PQ) and complete batch records.
Quality Assurance Vendor self-declared without required formal QMS. Mandatory QA/QC unit, Change Control, CAPA, and vendor audits.
Regulatory Impact High risk of IND rejection if used as a critical raw material. Required for IND/NDA filings, supported by Drug Master Files (DMF).

Footnotes

Regulatory Note: Governed by FDA (21 CFR Parts 210/211/312), EMA (EudraLex Vol 4), ICH Guidelines (E6/Q7/Q9/Q10), and compendial standards (USP <71>/<85>/<1043>).

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Note: Technical data last updated: Sep 1, 2026.