Clinical Trials

Nortriptyline hydrochloride is documented across numerous clinical trials spanning Phase 1 through Phase 4, investigating psychiatric, neurological, and chronic pain conditions such as major depressive disorder, postherpetic neuralgia, and migraine. Supported by prominent academic and research sponsors, including Duke University and Johns Hopkins University, these studies encompass recruitment statuses ranging from active and recruiting to completed and terminated. This clinical landscape highlights ongoing research into optimizing tricyclic antidepressant therapy for affective disorders and neuropathic pain management.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT07655440 NOT_YET_RECRUITING
Migraine Associated Vertigo; Tinnitus; Migraine; Vestibular Migraine
Stanford University
 2026-07 PHASE4
NCT05582837 RECRUITING
Ménière
University of California, Irvine
 2022-08-01 PHASE4
NCT06799169 ACTIVE_NOT_RECRUITING
Tinnitus
University of California, Irvine
 2025-06-01 PHASE4
NCT03652571 TERMINATED
Functional Dyspepsia
Maastricht University Medical Center
 2018-09-01 PHASE3
NCT05531591 COMPLETED
Depression; Dementia; Mild Cognitive Impairment; Treatment Resistant Depression; Major Depressive Disorder; Treatment-Refractory Depression; Late Life Depression; Geriatric Depression
Centre for Addiction and Mental Health
 2019-08-01 PHASE4
NCT03844412 COMPLETED
Vestibulodynia; Temporomandibular Disorder; Fibromyalgia Syndrome; Irritable Bowel Syndrome; Migraines; Tension Headache; Endometriosis; Interstitial Cystitis; Back Pain; Chronic Fatigue Syndrome
Duke University
 2019-11-04 PHASE2
NCT04404439 COMPLETED
Tinnitus, Subjective; Tinnitus
University of California, Irvine
 2019-09-26 PHASE4
NCT04226365 TERMINATED
Concussion Post Syndrome; Headaches Posttraumatic; Mild Traumatic Brain Injury
Lancaster General Hospital
 2020-02-15 PHASE4
NCT03652870 COMPLETED
Depression; Parkinson Disease
University College, London
 2021-03-05 PHASE3
NCT02960763 COMPLETED
Treatment Resistant Depression; Major Depressive Disorder; Treatment-Refractory Depression; Late Life Depression; Geriatric Depression
Washington University School of Medicine
 2017-02-24 PHASE4
NCT02169830 TERMINATED
Migraine Disorders
St. Louis University
 2014-08-22
NCT02881125 COMPLETED
Small Cell Carcinoma
University of Washington
 2016-11-03 PHASE1
NCT02260388 COMPLETED
Cryptogenic Sensory Polyneuropathy
University of Kansas Medical Center
 2014-10 PHASE4
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02237937 UNKNOWN
Major Depression
HolsboerMaschmeyer NeuroChemie GmbH
 2011-09 PHASE4
NCT02901249 COMPLETED
Depression
Federal University of Rio Grande do Sul
 2010-05 PHASE4
NCT00660062 TERMINATED
Major Depression
Hillerod Hospital, Denmark
 2009-08 PHASE4
NCT02918097 COMPLETED
Bipolar Disorder
Federal University of Rio Grande do Sul
 2010-05 PHASE4
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT01144923 COMPLETED
Cervical Radiculopathy
Johns Hopkins University
 2010-06
NCT00765895 COMPLETED
Idiopathic Gastroparesis
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
 2009-01 PHASE3
NCT00612807 COMPLETED
Major Depressive Disorder; Partner Relational Disorder (V61.10)
Duke University
 2006-07 PHASE1; PHASE2
NCT01065649 COMPLETED
Gastroesophageal Reflux Disease
Universidade de Passo Fundo
 2010-01 PHASE3
NCT00547703 TERMINATED
Non Ulcer Dyspepsia
The Cleveland Clinic
 2008-02
NCT00062738 COMPLETED
Parkinson Disease; Depression
Rutgers, The State University of New Jersey
 2003-06 PHASE2
NCT00796211 COMPLETED
Plaque Psoriasis
Zalicus
 2008-11 PHASE2
NCT00721331 COMPLETED
Atopic Dermatitis
Zalicus
 2008-07 PHASE1
NCT00066937 COMPLETED
Temporomandibular Joint Disorders
Johns Hopkins University
 2002-11 PHASE2
NCT00557739 COMPLETED
Plaque Psoriasis
Zalicus
 2007-11 PHASE2
NCT00045916 COMPLETED
Depression; Depressive Disorder; Bipolar Disorder
New York State Psychiatric Institute
 2001-02 PHASE4
NCT02256878 COMPLETED
Healthy
Boehringer Ingelheim
 2004-08 PHASE1
NCT00018148 COMPLETED
Smoking
US Department of Veterans Affairs
 1998-04 PHASE2
NCT00000378 COMPLETED
Depression; Melancholia
New York State Psychiatric Institute
 1997-07 PHASE4
NCT00000377 COMPLETED
Depression
University of Pittsburgh
 1989-03
NCT00004390 COMPLETED
Pain; Herpes Zoster
National Center for Research Resources (NCRR)
 1995-02 PHASE3
NCT00544687 COMPLETED
Healthy
Zalicus
 2007-09 PHASE1
NCT00021528 COMPLETED
Depression
National Institute of Mental Health (NIMH)
 2001-07 PHASE4
NCT00000375 COMPLETED
Major Depressive Disorder
National Institute of Mental Health (NIMH)
 1997-02 PHASE4
NCT00009672 COMPLETED
Radiculopathy; Sciatica
National Institute of Dental and Craniofacial Research (NIDCR)
 2001-01-30 PHASE2
NCT01268709 COMPLETED
Irritable Bowel Syndrome
Qom University of Medical Sciences
 PHASE2

(data from https://clinicaltrials.gov, updated on 2026-06-17)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Nortriptyline hydrochloride acts as a tricyclic antidepressant that selectively inhibits the presynaptic reuptake of norepinephrine and serotonin within the central nervous system. By elevating synaptic neurotransmitter concentrations and dampening nociceptive signal transmission, it provides clinical efficacy in the management of major depressive disorder, postherpetic neuralgia, and associated chronic pain conditions.

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.