Clinical Trials

Numerous clinical trials spanning Phase 1 through Phase 4 evaluate clomipramine across pharmacokinetic studies in healthy volunteers and clinical indications such as obsessive-compulsive disorder, depression, premature ejaculation, anxiety disorders, schizophrenia, and dementia. Sponsored by academic institutions and pharmaceutical companies, these trials exhibit varying recruitment statuses, including completed, terminated, and unknown.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT02571101 UNKNOWN
Premature Ejaculation
CTC Bio, Inc.
 2015-11 PHASE2
NCT01896349 UNKNOWN
Treatment Resistant Depression
Hospital de Clinicas de Porto Alegre
 2013-04
NCT02028598 COMPLETED
Healthy
CTC Bio, Inc.
 2014-01 PHASE1
NCT01439984 COMPLETED
Premature Ejaculation
Symyoo
 2011-09 PHASE3
NCT01404871 COMPLETED
Obsessive Compulsive Disorder
Sunnybrook Health Sciences Centre
 2009-04
NCT01203202 COMPLETED
Premature Ejaculation
Symyoo
 2010-09 PHASE2
NCT00466609 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2007-05 PHASE4
NCT00564564 COMPLETED
Obsessive Compulsive Disorder
University of Sao Paulo
 2006-01 PHASE4
NCT01575158 COMPLETED
Depression
University of Aarhus
 1997-10
NCT00913952 COMPLETED
Depression
Sandoz
 1994-04 PHASE1
NCT00913783 COMPLETED
Depression
Sandoz
 1992-11 PHASE1
NCT00254735 COMPLETED
Obsessive Compulsive Disorder
AstraZeneca
 2002-04 PHASE3
NCT00004310 UNKNOWN
Obsessive-Compulsive Disorder
National Center for Research Resources (NCRR)
 1999-10 PHASE2

(data from https://clinicaltrials.gov, updated on 2018-02-28)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Clomipramine acts as a non-selective monoamine reuptake inhibitor that binds presynaptic monoamine transporters to inhibit serotonin reuptake with an IC50 of 1.5 nM and reduce central norepinephrine production, thereby modulating synaptic neurotransmitter concentrations. This elevation in synaptic monoamine levels exerts anticholinergic and sedative cellular effects, alleviating psychiatric symptoms in conditions evaluated in clinical trials, including obsessive-compulsive disorder and depression.

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.