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Gold nanoparticles may make lithium therapy safer and more effective
NCT ID NCT07732933
First seen Jul 29, 2026 · Last updated Jul 30, 2026 · Updated 1 time
Summary
This lab study tests whether gold nanoparticles can carry lithium directly to brain cells, potentially reducing side effects. Researchers will use neural cells grown from blood samples of people with bipolar disorder and healthy volunteers, plus a mouse model of mania. The goal is to see if nanoparticle-delivered lithium works better than standard lithium salts at lower doses.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lithium-loaded gold nanoparticles (LiG-AuNPs)
- What this could lead to
- If successful, this could pave the way for a safer, more targeted lithium therapy for bipolar disorder, reducing side effects.
- What could go wrong
- This is an early lab study using cells and mice, not humans. The nanoparticles may not work as hoped or could have unforeseen toxicity.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 20 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Mar 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 65 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168, Italy
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