Testing a New Gold Nanoparticle-Based Lithium Delivery Method for Bipolar Disorder in Laboratory Models

NCT07732933 · tracked via the Priya Life Science Italy tracker

Sponsor

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Phase

Not applicable

Started

2026-10-01

Last updated

2026-07-29

Condition(s) studied

Bipolar Disorder (BD)Bipolar Disorder (BPD)

Investigational drug(s) / intervention(s)

Peripheral blood sampling for PBMC isolation

Peripheral blood sampling for PBMC isolation: Blood collection in EDTA tubes for isolation of peripheral blood mononuclear cells (PBMCs), followed by reprogramming into induced pluripotent stem cells (iPSCs) via Sendai virus infection and differentiation into human induced neural stem cells (hiNSCs), used for the in vitro experiments of the protocol. No drug or device is administered to participants.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

65 Years

Healthy volunteers

Accepted

Inclusion Criteria: Inclusion criteria for patients * 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 Criteria: * 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. * Active suicidal ideation with plan or intent * History of major neurological disorders, including epilepsy, traumatic brain injury, or neurodegenerative disease. * Previous exposure to lithium at any point in the individual's psychiatric history. * Use of psychotropic medication within the 12 months before enrollment. * Presence of uncontrolled or clinically significant medical conditions, including but not limited to severe hepatic, renal, or cardiovascular disease.

Primary outcome measure(s)

Intracellular lithium concentration in patient derived neural cells (hiNSCs) treated with LiG-AuNPs versus lithium salts (LiCl) — 1, 2, 6, 12, and 24 hours after in vitro treatment (assessed throughout the 3-year study period)
Quantification of intracellular lithium load by Inductively Coupled Plasma-Optical Emission Spectroscopy (ICP-OES) and subcellular gold nanoparticle distribution by Transmission Electron Microscopy (TEM) in neurons, astrocytes, and oligodendrocytes differentiated from participant-derived human induced Neural Stem Cells (hiNSCs), treated with Lithium-loaded, Glutathione-coated Gold Nanoparticles (LiG-AuNPs) or Lithium Chloride (LiCl) at concentrations of 0.15, 0.5, 1, 3, and 6 mEq/L, to compare uptake efficiency between the two delivery methods.

Trial sites (1)

Facility	City	Region	Status
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Roma	Italy

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07732933 on ClinicalTrials.gov ↗ ← All trials in Italy