Clinical Trials

Numerous clinical trials evaluate ziprasidone across a broad spectrum of psychiatric conditions, primarily focusing on schizophrenia, bipolar disorder, schizoaffective disorder, and major depression. Spanning Early Phase 1 through Phase 4, these studies assess acute symptom control, maintenance efficacy, sleep architecture, and metabolic profiles. Encompassing completed, active, terminated, and withdrawn recruitment statuses, research is supported by pharmaceutical sponsors such as Pfizer and Viatris as well as academic institutions.

NCT Number Recruitment Conditions Sponsor/Collaborators Start Date Phases
NCT03781115 ACTIVE_NOT_RECRUITING
Schizophrenia
University of Arizona
 2017-11-20 PHASE1
NCT04446234 UNKNOWN
Schizophrenia
Shanghai Mental Health Center
 2021-05 PHASE4
NCT03837860 TERMINATED
Opioid Abuse, Unspecified; Opioid Dependence
The University of Texas Health Science Center at San Antonio
 2019-04-01 EARLY_PHASE1
NCT03768726 TERMINATED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2018-12-21 PHASE3
NCT02075047 TERMINATED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2014-05-23 PHASE3
NCT03011645 TERMINATED
Cardiovascular Diseases
Duke University
 2018-05-24 PHASE1
NCT03557931 COMPLETED
Schizophrenia
Astellas Pharma Global Development, Inc.
 2018-07-13 PHASE2
NCT04587115 COMPLETED
Addiction
The University of Texas Health Science Center at San Antonio
 2017-06-16 EARLY_PHASE1
NCT04076371 COMPLETED
Schizophrenia
Beijing HuiLongGuan Hospital
 2012-01
NCT02935998 UNKNOWN
Schizophrenia
Yang Fude
 2016-10 PHASE4
NCT02282085 UNKNOWN
Schizophrenia
Matt Byerly
 2014-12 PHASE4
NCT01211522 COMPLETED
Delirium; Impaired Cognition; Long Term Psychologic Disorders
Vanderbilt University Medical Center
 2011-12-14 PHASE3
NCT02374567 TERMINATED
Dementia; Depression; Schizophrenia; Psychosomatic Disorders; Anxiety Disorders
Hannover Medical School
 2015-01 PHASE3
NCT01185743 COMPLETED
Schizophrenia; Diabetes
Medical University of Vienna
 2010-07 PHASE4
NCT02650102 UNKNOWN
Schizophrenia
Shanxi Medical University
 2013-01 PHASE1; PHASE2
NCT02307396 COMPLETED
Schizophrenia; Schizophrenia and Disorders With Psychotic Features; Schizoaffective Disorders
Technical University of Munich
 2015-02-01 PHASE4
NCT01893229 UNKNOWN
Bipolar Disorder
Guiyun Xu
 2013-09 PHASE4
NCT02040883 UNKNOWN
Schizophrenia
Qingyun Yin
 2014-02 PHASE4
NCT02192723 COMPLETED
Schizophrenia
Beijing HuiLongGuan Hospital
 2012-06
NCT01844700 TERMINATED
High Risk MC4R Genotype; Low Risk MC4R Genotype; One Week or Less Antipsychotic Lifetime Exposure
Northwell Health
 2013-07 PHASE4
NCT00633399 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2008-07 PHASE2
NCT00806234 COMPLETED
Psychotic Disorders
Johns Hopkins University
 2009-01 PHASE4
NCT02526030 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2008-10 PHASE4
NCT01198353 COMPLETED
Schizophrenia; Schizoaffective Disorder
Soonchunhyang University Hospital
 2010-09 PHASE4
NCT00635700 COMPLETED
Psychosis Prodrome
Yale University
 2008-03 PHASE2
NCT01293825 COMPLETED
Medication Adherence; Bipolar Disorder
University Hospitals Cleveland Medical Center
 2011-01 PHASE4
NCT00910988 COMPLETED
Hyperglycemia; Hyperlipidemia
Washington University School of Medicine
 2009-02
NCT00748566 TERMINATED
Schizophrenia and Disorders With Psychotic Features
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2008-12 PHASE4
NCT01168674 COMPLETED
Depression; Bipolar Disorder
Tufts Medical Center
 2010-02 PHASE4
NCT01124877 WITHDRAWN
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2010-07 PHASE3
NCT01172652 COMPLETED
Bipolar Disorder; Panic Disorder; Generalized Anxiety Disorder
VA Palo Alto Health Care System
 2010-04 PHASE4
NCT01714011 COMPLETED
Schizophrenia
University of Malaya
 2009-05 PHASE4
NCT00786318 WITHDRAWN
Psychosis; Agitation; Delirium
George Washington University
 2008-09 PHASE4
NCT00835107 COMPLETED
Depression, Bipolar
Queen's University
 2009-02 PHASE4
NCT00403546 COMPLETED
Schizophrenia
Donald C. Goff, MD
 2006-01 PHASE3
NCT01117220 WITHDRAWN
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2010-06 PHASE3
NCT00538642 COMPLETED
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
The University of Texas Health Science Center at San Antonio
 2007-08
NCT01485692 COMPLETED
Psychomotor Agitation
University of Sao Paulo
 2009-02
NCT00509067 COMPLETED
Schizophrenia
Georgetown University
 2007-11 PHASE2
NCT02305823 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2005-10 PHASE4
NCT01113541 TERMINATED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2010-07 PHASE3
NCT00330863 COMPLETED
Schizophrenia; Schizoaffective Disorder
Northwell Health
 2006-05 PHASE4
NCT02534363 COMPLETED
Schizophrenia; Psychotic Disorders
Fundación Marques de Valdecilla
 2005-10 PHASE4
NCT00818298 COMPLETED
Schizophrenia; Schizoaffective Disorder
Centre for Addiction and Mental Health
 2009-01
NCT01245348 Completed
Schizophrenia|Bipolar Disorder
Medco Health Solutions Inc.|SureGene LLC
 2010-12 --
NCT00555997 COMPLETED
Major Depressive Disorder
Massachusetts General Hospital
 2008-03 PHASE2
NCT00617058 TERMINATED
Weight Gain
University of North Carolina, Chapel Hill
 2007-03 PHASE2
NCT00932529 COMPLETED
Psychotic Disorders
University of Bergen
 2003-02 PHASE4
NCT00395031 COMPLETED
Schizophrenia; Schizoaffective Disorder
Manhattan Psychiatric Center
 2003-09 PHASE2; PHASE3
NCT00472641 COMPLETED
Bipolar Disorder
Stanford University
 2007-01 PHASE4
NCT00622739 COMPLETED
Bipolar Disorder
Baylor College of Medicine
 2007-02 PHASE4
NCT00490542 COMPLETED
Bipolar Disorder; Bipolar Depression; Depression
Tufts Medical Center
 2006-12 PHASE2
NCT00723606 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2008-09 PHASE3
NCT00265382 TERMINATED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-06 PHASE3
NCT00139737 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2002-03 PHASE3
NCT01714011 Completed
Schizophrenia
University of Malaya
 2009-05 Phase 4
NCT00821444 COMPLETED
Healthy
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2009-01 PHASE1
NCT00044655 COMPLETED
Schizophrenia
Icahn School of Medicine at Mount Sinai
 2001-07 PHASE4
NCT00257192 TERMINATED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-04 PHASE3
NCT00835107 Completed
Depression Bipolar
Queen''s University|Providence Health & Services|Pfizer|MDS Pharma Services
 2009-02 Phase 4
NCT00288366 COMPLETED
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
Northwestern University
 2006-01
NCT00483548 COMPLETED
Bipolar Disorder; Depression, Bipolar
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2007-10 PHASE3
NCT00288353 TERMINATED
Schizophrenia; Schizoaffective Disorder; Bipolar Disorder
Northwestern University
 2006-01 PHASE3
NCT00312494 COMPLETED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-04 PHASE3
NCT00406315 COMPLETED
Schizophrenia; Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-11 PHASE4
NCT00215150 COMPLETED
Social Anxiety Disorder
Duke University
 2004-11 PHASE2
NCT00515723 COMPLETED
Schizophrenia; Schizoaffective Disorder; Type 2 Diabetes Mellitus; Hyperglycemia
Washington University School of Medicine
 2001-09
NCT00225498 COMPLETED
Schizophrenia
Northwell Health
 2002-06
NCT00174447 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2001-10 PHASE3
NCT00676429 COMPLETED
Conduct Disorder; Oppositional Defiant Disorder
University Hospital Freiburg
 2006-07 PHASE2
NCT01157559 COMPLETED
First Episode Psychosis
Chonbuk National University Hospital
 PHASE4
NCT00280566 COMPLETED
Bipolar Mania; Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2005-12 PHASE3
NCT00421954 COMPLETED
Schizophreniform Disorder; Schizoaffective Disorder; Psychosis; Depressive Disorder, Major; Bipolar Disorder
New York State Psychiatric Institute
 2006-05 PHASE3
NCT00229385 COMPLETED
Schizophrenia; Obsessive Compulsive Disorder
Sheba Medical Center
 2006-01
NCT00458211 COMPLETED
Schizophrenia; Schizoaffective Disorder
Bronx Psychiatric Center
 2005-05 PHASE4
NCT00282464 COMPLETED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-02 PHASE3
NCT00141271 COMPLETED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2005-07 PHASE3
NCT00237666 COMPLETED
Bipolar II Disorder; Major Depressive Episode
The Medical Research Network
 2005-02 PHASE4
NCT00347425 COMPLETED
Schizophrenia and Schizoaffective Disorder
Solvay Pharmaceuticals
 2006-12 PHASE3
NCT00265330 COMPLETED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-03 PHASE3
NCT00374543 TERMINATED
Generalized Anxiety Disorder; Bipolar Disorder
Massachusetts General Hospital
 2006-02 PHASE4
NCT00096863 COMPLETED
Delirium; Cognition Disorders
Vanderbilt University
 2004-12 PHASE2
NCT00257166 COMPLETED
Bipolar Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-01 PHASE3
NCT00329108 TERMINATED
Acute Mania; Bipolar Disorder, Manic
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2006-11 PHASE4
NCT00148564 COMPLETED
Schizophrenia
Charite University, Berlin, Germany
 2004-03 PHASE4
NCT00205725 COMPLETED
Schizophrenia; Type 2 Diabetes Mellitus
Washington University School of Medicine
 2000-11
NCT00254202 COMPLETED
Schizophrenia
Vanda Pharmaceuticals
 2005-11-18 PHASE3
NCT00048802 COMPLETED
Bipolar Disorder
Northwell Health
 2002-08 PHASE4
NCT00676429 Completed
Conduct Disorder|Oppositional Defiant Disorder
University Hospital Freiburg|Pfizer
 2006-07 Phase 2
NCT00635921 COMPLETED
Borderline Personality Disorder
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2004-03 PHASE2
NCT01006551 COMPLETED
Schizophrenia
University of North Carolina, Chapel Hill
 2002-12 PHASE2
NCT00340379 COMPLETED
Affective Disorders
Duke University
 2003-04 PHASE2; PHASE3
NCT00208559 COMPLETED
Autism
Drexel University College of Medicine
 2002-02 PHASE2
NCT01581866 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2004-11 PHASE1
NCT01581879 COMPLETED
Healthy
Dr. Reddy's Laboratories Limited
 2004-11 PHASE1
NCT00148564 Completed
Schizophrenia
Charite University Berlin Germany
 2004-03 Phase 4
NCT00197951 COMPLETED
Depression; Anger; Anxiety; Alcoholism
Fundació Institut de Recerca de l'Hospital de la Santa Creu i Sant Pau
 2004-10 PHASE3
NCT00297960 COMPLETED
Healthy Male Volunteers
Medical University of Vienna
 2005-04 PHASE4
NCT00159757 TERMINATED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-11 PHASE4
NCT00199940 COMPLETED
Schizophrenia; Affective Disorders; Psychotic Disorder; Psychotic Mood Disorder
Medical College of Wisconsin
 2003-12 PHASE4
NCT00650429 COMPLETED
Schizophrenia; Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-10 PHASE4
NCT00645320 COMPLETED
Pyschotic Disorders
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-08 PHASE4
NCT00145444 COMPLETED
Schizophrenia; Psychotic Disorders
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-03 PHASE3
NCT00645372 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2004-07 PHASE3
NCT00418171 COMPLETED
Schizophrenia
Pfizer
 2002-02 PHASE4
NCT00136994 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-03 PHASE3
NCT00645515 TERMINATED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-06 PHASE3
NCT00649064 COMPLETED
Schizoaffective Disorder; Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-12 PHASE4
NCT00634348 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2004-04 PHASE4
NCT00239109 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-04 PHASE4
NCT00649844 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-01 PHASE3
NCT00137020 COMPLETED
Schizophrenia; Psychotic Disorders
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2004-11 PHASE4
NCT00208208 COMPLETED
Posttraumatic Stress Disorder; Post-Traumatic Stress Disorder; PTSD
Creighton University
 2002-12 PHASE4
NCT00159770 COMPLETED
Schizophrenia; Schizoaffective Disorder; Psychotic Disorders
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2001-11 PHASE3
NCT00224315 COMPLETED
Schizophrenia, Schizoaffective Disorder
Central Institute of Mental Health, Mannheim
 2003-11 PHASE4
NCT00351000 COMPLETED
Schizophrenia
North Suffolk Mental Health Association
 2005-01 PHASE4
NCT00143351 COMPLETED
Schizophrenia
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-06 PHASE3
NCT00014001 COMPLETED
Schizophrenia
National Institute of Mental Health (NIMH)
 2000-12 PHASE4
NCT00181922 COMPLETED
Bipolar Disorder; Mania
Massachusetts General Hospital
 2002-03 PHASE4
NCT00644800 COMPLETED
Schizophrenia; Mania; Delusional Disorder; Acute Exacerbation of Psychosis
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-07 PHASE4
NCT00034801 COMPLETED
Depression; Schizophrenia; Schizoaffective Disorder
Eli Lilly and Company
 2001-09 PHASE4
NCT00650611 COMPLETED
Schizophrenia; Bipolar Disorder; Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2003-12 PHASE2
NCT00645229 TERMINATED
Schizophrenia; Schizoaffective Disorder
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
 2004-09 PHASE3

(data from https://clinicaltrials.gov, updated on 2026-07-08)

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

Compliance for Clinical Use

Mechanism and Biochemical Profile

Ziprasidone acts as a potent antagonist of central dopamine D2 and serotonin 5-HT2A receptors, inhibiting downstream monoaminergic signal transduction pathways. This receptor blockade suppresses hyperactive dopaminergic neurotransmission while balancing serotonergic tone, providing the therapeutic foundation for symptom reduction in patients with schizophrenia and bipolar disorder.

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.