Lithium carried by gold nanoparticles for bipolar disorder, tested in laboratory models
Tests lithium-loaded gold nanoparticles in cells made from blood of people with bipolar disorder.
Plain-language title generated from the registry record
Registry title: Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models
Key facts
- Where
- Roma, ItalySee the site
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 65 years old?
Source: NCT07732933, who can take part
Where in Italy
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSRoma, ItalyNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Trial code
- NCT07732933
- Record updated
- 29 July 2026
- Original description
This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues.Read full original descriptionShow less
GSK-3 as a Target for Lithium-charged Au Nanoparticles in Bipolar Disorder
This preclinical translational study aims to evaluate a new method of delivering lithium using gold nanoparticles for the treatment of bipolar disorder. Lithium is an effective treatment for bipolar disorder, but its clinical use is limited by a narrow therapeutic range and the risk of side effects. The study will investigate whether gold nanoparticles carrying lithium can improve lithium delivery to brain cells while reducing exposure to other tissues.
The research will use human induced pluripotent stem cell (iPSC)-derived neural cells generated from blood samples collected from people with bipolar disorder and healthy volunteers, as well as a mouse model of mania. No participants will receive the investigational treatment. Human participants will provide blood samples only for the generation of laboratory cell models.
The study will compare the effects of nanoparticle-delivered lithium with conventional lithium salts on cellular lithium uptake, disease-related molecular and functional changes, and biomarkers associated with bipolar disorder. The hypothesis is that lithium delivered by gold nanoparticles will achieve greater therapeutic effects at lower systemic lithium exposure than conventional lithium formulations, providing proof of concept for a safer and more targeted lithium delivery strategy for future clinical development.
Inclusion: Age: 18-65 years; Diagnosis of Bipolar I or Bipolar II Disorder, according to DSM-5 criteria; Currently in a depressive, manic, hypomanic, mixed, or euthymic phase, as defined by DSM-5 and clinical evaluation; No use of psychotropic medications during the 12 months preceding enrollment, except for low-dose benzodiazepines or antipsychotics used intermittently to manage sleep disturbances or anxiety symptoms; No prior treatment with lithium at any point in the patient's psychiatric history; Medically stable and deemed suitable for study participation; Ability and willingness to provide written informed consent before any study procedure For the Human Healthy Control group; participants aged 18-65 years will be included, while subjects with DSM-5 disorders or a family history of psychiatric disorders will be excluded.
Exclusion: Previous exposure to lithium at any point in the individual's psychiatric history; Use of psychotropic medication within the 12 months before enrollment; Current or past diagnosis of schizophrenia, schizoaffective disorder, or borderline personality disorder as the primary psychiatric condition; Diagnosis of moderate to severe substance use disorder (excluding nicotine) within the past 12 months; History of major neurological disorders, including epilepsy, traumatic brain injury, or neurodegenerative disease; Presence of uncontrolled or clinically significant medical conditions, including but not limited to severe hepatic, renal, or cardiovascular disease; Active suicidal ideation with plan or intent.