Bipolar Disorder (BD)GLADNCT07732933

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

A study testing Peripheral blood sampling for PBMC isolation in people with Bipolar Disorder (BD) and Bipolar Disorder (BPD), run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Bipolar Disorder (BD), Bipolar Disorder (BPD)
What is being tested?: Peripheral blood sampling for PBMC isolation
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 20 participants
Where: 1 siteItaly
Study dates: 1 Oct 2026to 31 Mar 2029
Phase: Interventional
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Gabriele Sani contact

+39 06 30155807

gabriele.sani@policlinicogemelli.it

Italy1 site

Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, 00168
Gabriele Sani, +39 06 30155807, gabriele.sani@policlinicogemelli.it

Other trials in Italy

About this study

Official title: GSK-3 as a Target for Lithium-charged Au Nanoparticles in Bipolar Disorder

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.

Conditions: Bipolar Disorder (BD), Bipolar Disorder (BPD)
Being tested: Peripheral blood sampling for PBMC isolation
Medical subject headings: Bipolar Disorder

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Peripheral blood sampling for PBMC isolationProcedure or surgery
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 groups in NCT07732933
Study group	Role	What they receive
Biological sample collection for iPSC/hiNSC generation	Experimental	Includes both patients with Bipolar I or II Disorder (per DSM-5 criteria) and Human Healthy Controls (HC), recruited at the UOC of Clinical and Emergency Psychiatry, Fondazione Policlinico Universitario A. Gemelli IRCCS. All participants undergo the same peripheral blood sampling procedure, with no drug or device administered. The distinction between BD patients and healthy controls is defined by eligibility/diagnostic criteria, not by assignment or randomization to distinct arms Receives: Procedure: Peripheral blood sampling for PBMC isolation

What is being measured

The primary outcome is the main question the study is designed to answer.

Intracellular lithium concentration in patient derived neural cells (hiNSCs) treated with LiG-AuNPs versus lithium salts (LiCl)
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.
Measured: 1, 2, 6, 12, and 24 hours after in vitro treatment (assessed throughout the 3-year study period)

Secondary outcomes (3)

Functional and biophysical differences
Comparison of neuronal parameters (resting membrane potential, action potential threshold, α-amino-3-hydroxy-5-methyl-4-isoxazolepropionic acid/N-methyl-D-aspartate (AMPA/NMDA) current ratio, frequency/amplitude of miniature excitatory postsynaptic currents, synaptic vesicle release) and astrocytic parameters (intracellular Ca²⁺ signaling, glutamate buffering/Excitatory Amino Acid Transporter 2 (EAAT2) activity, gliotransmitter release) between human induced Neural Stem Cell (hiNSC)-derived neurons/astrocytes from Bipolar Disorder (BD) patients versus healthy controls, before and after lithium exposure.
Measured: Assessed at 30 days of in vitro differentiation (within the 3-year study period)
Molecular biomarker expression in patient-derived neural cells
Levels of c-Fos, Synaptotagmin-7, Neuronal Pentraxin 2 (NPTX2), B-cell lymphoma 2 (Bcl-2), phospho-Glycogen Synthase Kinase 3 beta (GSK-3β)(Ser9)/total GSK-3β, and phospho-cytosolic Phospholipase A2 (cPLA2)(Ser505)/total cPLA2 in human induced Neural Stem Cell (hiNSC)-derived neurons and astrocytes from Bipolar Disorder (BD) patients.
Measured: Assessed at 30 days of in vitro differentiation (within the 3-year study period)
Blood biomarker profile in BD patients versus healthy controls
Plasma lithium levels, Thyroid Stimulating Hormone (TSH) levels, lithium load in blood cells, phospho-Glycogen Synthase Kinase 3 beta (pGSK-3β)(Ser9)/total GSK-3β ratio, and phospho-cytosolic Phospholipase A2 (cPLA2)(Ser505)/total cPLA2 levels, measured in blood cells and plasma from Bipolar Disorder (BD) patients (during the manic phase and again after standard lithium therapy) and from healthy controls, for comparison and biomarker identification.
Measured: Baseline (single blood draw) and up to 24 hours after in vitro lithium exposure (within the 3-year study period)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Oct 202631 Mar 2029

First posted29 Jul 2026
Study start1 Oct 2026 (estimated)
Primary completion30 Sep 2027 (estimated)
Study completion31 Mar 2029 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (15)Papers the sponsor has linked to this study.
Other trials for Bipolar Disorder (BD)Studies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 20 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07732933
Sponsor's protocol ID: RF-2024-12379870
Acronym: GLAD
Status last verified: Jul 2026
First submitted: 21 Jul 2026
Last updated: 29 Jul 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Individual participant data will not be shared outside the research team due to the sensitive nature of the clinical, psychiatric, and biological data collected, including genetic and cellular material derived from patients with Bipolar Disorder. Data protection and confidentiality commitments made to participants during the informed consent process do not include provisions for external data sharing. Aggregate, de-identified results will be disseminated through peer-reviewed publications

Publications

Buonerba A, Lapenta R, Della Monica F, Piacentini R, Baldino L, Scognamiglio MR, Speranza V, Milione S, Capacchione C, Rieger B, Grassi A. Thermo- and Photoresponsive Smart Nanomaterial Based on Poly(diethyl vinyl phosphonate)-Capped Gold Nanoparticles. Nanomaterials (Basel). 2024 Oct 1;14(19):1589. doi: 10.3390/nano14191589.
PubMed 39404316
Aceto G, Nardella L, Nanni S, Pecci V, Bertozzi A, Nutarelli S, Viscomi MT, Colussi C, D'Ascenzo M, Grassi C. Glycine-induced activation of GPR158 increases the intrinsic excitability of medium spiny neurons in the nucleus accumbens. Cell Mol Life Sci. 2024 Jun 17;81(1):268. doi: 10.1007/s00018-024-05260-w.
PubMed 38884814
Scala F, Fusco S, Ripoli C, Piacentini R, Li Puma DD, Spinelli M, Laezza F, Grassi C, D'Ascenzo M. Intraneuronal Abeta accumulation induces hippocampal neuron hyperexcitability through A-type K(+) current inhibition mediated by activation of caspases and GSK-3. Neurobiol Aging. 2015 Feb;36(2):886-900. doi: 10.1016/j.neurobiolaging.2014.10.034. Epub 2014 Nov 4.
PubMed 25541422
Fusco S, Leone L, Barbati SA, Samengo D, Piacentini R, Maulucci G, Toietta G, Spinelli M, McBurney M, Pani G, Grassi C. A CREB-Sirt1-Hes1 Circuitry Mediates Neural Stem Cell Response to Glucose Availability. Cell Rep. 2016 Feb 9;14(5):1195-1205. doi: 10.1016/j.celrep.2015.12.092. Epub 2016 Jan 21.
PubMed 26804914
De Chiara G, Piacentini R, Fabiani M, Mastrodonato A, Marcocci ME, Limongi D, Napoletani G, Protto V, Coluccio P, Celestino I, Li Puma DD, Grassi C, Palamara AT. Recurrent herpes simplex virus-1 infection induces hallmarks of neurodegeneration and cognitive deficits in mice. PLoS Pathog. 2019 Mar 14;15(3):e1007617. doi: 10.1371/journal.ppat.1007617. eCollection 2019 Mar.
PubMed 30870531
Mastrodonato A, Barbati SA, Leone L, Colussi C, Gironi K, Rinaudo M, Piacentini R, Denny CA, Grassi C. Olfactory memory is enhanced in mice exposed to extremely low-frequency electromagnetic fields via Wnt/beta-catenin dependent modulation of subventricular zone neurogenesis. Sci Rep. 2018 Jan 10;8(1):262. doi: 10.1038/s41598-017-18676-1.
PubMed 29321633
Tropea MR, Melone M, Li Puma DD, Vacanti V, Aceto G, Bandiera B, Trovato RC, Torrisi SA, Leggio GM, Palmeri A, D'Ascenzo M, Conti F, Grassi C, Puzzo D. Blockade of dopamine D3 receptors improves hippocampal synaptic function and rescues age-related cognitive phenotype. Aging Cell. 2024 Nov;23(11):e14291. doi: 10.1111/acel.14291. Epub 2024 Sep 5.
PubMed 39236310
Bandiera B, Natale F, Rinaudo M, Sollazzo R, Spinelli M, Fusco S, Grassi C. Olfactory stimulation with multiple odorants prevents stress-induced cognitive and psychological alterations. Brain Commun. 2024 Nov 5;6(6):fcae390. doi: 10.1093/braincomms/fcae390. eCollection 2024.
PubMed 39564126
Markov DD. Sucrose Preference Test as a Measure of Anhedonic Behavior in a Chronic Unpredictable Mild Stress Model of Depression: Outstanding Issues. Brain Sci. 2022 Sep 24;12(10):1287. doi: 10.3390/brainsci12101287.
PubMed 36291221
Puliatti G, Li Puma DD, Aceto G, Lazzarino G, Acquarone E, Mangione R, D'Adamio L, Ripoli C, Arancio O, Piacentini R, Grassi C. Intracellular accumulation of tau oligomers in astrocytes and their synaptotoxic action rely on Amyloid Precursor Protein Intracellular Domain-dependent expression of Glypican-4. Prog Neurobiol. 2023 Aug;227:102482. doi: 10.1016/j.pneurobio.2023.102482. Epub 2023 Jun 14.
PubMed 37321444
Li Puma DD, Ripoli C, Puliatti G, Pastore F, Lazzarino G, Tavazzi B, Arancio O, Piacentini R, Grassi C. Extracellular tau oligomers affect extracellular glutamate handling by astrocytes through downregulation of GLT-1 expression and impairment of NKA1A2 function. Neuropathol Appl Neurobiol. 2022 Aug;48(5):e12811. doi: 10.1111/nan.12811. Epub 2022 Mar 16.
PubMed 35274343
Ripoli C, Cocco S, Li Puma DD, Piacentini R, Mastrodonato A, Scala F, Puzzo D, D'Ascenzo M, Grassi C. Intracellular accumulation of amyloid-beta (Abeta) protein plays a major role in Abeta-induced alterations of glutamatergic synaptic transmission and plasticity. J Neurosci. 2014 Sep 17;34(38):12893-903. doi: 10.1523/JNEUROSCI.1201-14.2014.
PubMed 25232124
Li X, Chen B, Zhang D, Wang S, Feng Y, Wu X, Cui L, Ji M, Gong W, Verkhratsky A, Xia M, Li B. A novel murine model of mania. Mol Psychiatry. 2023 Jul;28(7):3044-3054. doi: 10.1038/s41380-023-02037-8. Epub 2023 Mar 29.
PubMed 36991130
Rosati J, Ferrari D, Altieri F, Tardivo S, Ricciolini C, Fusilli C, Zalfa C, Profico DC, Pinos F, Bernardini L, Torres B, Manni I, Piaggio G, Binda E, Copetti M, Lamorte G, Mazza T, Carella M, Gelati M, Valente EM, Simeone A, Vescovi AL. Establishment of stable iPS-derived human neural stem cell lines suitable for cell therapies. Cell Death Dis. 2018 Sep 17;9(10):937. doi: 10.1038/s41419-018-0990-2.
PubMed 30224709
Buonerba A, Lapenta R, Donniacuo A, Licasale M, Vezzoli E, Milione S, Capacchione C, Tecce MF, Falqui A, Piacentini R, Grassi C, Grassi A. NIR multiphoton ablation of cancer cells, fluorescence quenching and cellular uptake of dansyl-glutathione-coated gold nanoparticles. Sci Rep. 2020 Jul 9;10(1):11380. doi: 10.1038/s41598-020-68397-1.
PubMed 32647291

Interested in taking part?

Gabriele Sani

+39 06 30155807

gabriele.sani@policlinicogemelli.it

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Bipolar Disorder (BD) trials

Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: GSK-3 as a Target for Lithium-charged Au Nanoparticles in Bipolar Disorder
ClinicalTrials.gov ID: NCT07732933
Acronym / sponsor ID: GLAD / RF-2024-12379870
Conditions: Bipolar Disorder (BD), Bipolar Disorder (BPD)
Study type: Interventional
Recruitment status: Not yet recruiting
Enrolment: 20 participants (estimated)
Lead sponsor: Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
Study start: 1 Oct 2026 (estimated)
Primary completion: 30 Sep 2027 (estimated)
Study completion: 31 Mar 2029 (estimated)
First posted: 29 Jul 2026 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Biological sample collection for iPSC/hiNSC generation	Experimental	Procedure: Peripheral blood sampling for PBMC isolationIncludes both patients with Bipolar I or II Disorder (per DSM-5 criteria) and Human Healthy Controls (HC), recruited at the UOC of Clinical and Emergency Psychiatry, Fondazione Policlinico Universitario A. Gemelli IRCCS. All participants undergo the same peripheral blood sampling procedure, with no drug or device administered. The distinction between BD patients and healthy controls is defined by eligibility/diagnostic criteria, not by assignment or randomization to distinct arms

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Peripheral blood sampling for PBMC isolationBlood 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.	Procedure or surgery	Biological sample collection for iPSC/hiNSC generation

Primary outcome

Intracellular lithium concentration in patient derived neural cells (hiNSCs) treated with LiG-AuNPs versus lithium salts (LiCl)
Time frame: 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.

3 secondary outcomes

Functional and biophysical differences
Time frame: Assessed at 30 days of in vitro differentiation (within the 3-year study period)
Molecular biomarker expression in patient-derived neural cells
Time frame: Assessed at 30 days of in vitro differentiation (within the 3-year study period)
Blood biomarker profile in BD patients versus healthy controls
Time frame: Baseline (single blood draw) and up to 24 hours after in vitro lithium exposure (within the 3-year study period)

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2026.
Background: PubMed 39404316Buonerba A, Lapenta R, Della Monica F, Piacentini R, Baldino L, Scognamiglio MR, Speranza V, Milione S, Capacchione C, Rieger B, Grassi A. Thermo- and Photoresponsive Smart Nanomaterial Based on Poly(diethyl vinyl phosphonate)-Capped Gold Nanoparticles. Nanomaterials (Basel). 2024 Oct 1;14(19):1589. doi: 10.3390/nano14191589.
Background: PubMed 38884814Aceto G, Nardella L, Nanni S, Pecci V, Bertozzi A, Nutarelli S, Viscomi MT, Colussi C, D'Ascenzo M, Grassi C. Glycine-induced activation of GPR158 increases the intrinsic excitability of medium spiny neurons in the nucleus accumbens. Cell Mol Life Sci. 2024 Jun 17;81(1):268. doi: 10.1007/s00018-024-05260-w.
Background: PubMed 25541422Scala F, Fusco S, Ripoli C, Piacentini R, Li Puma DD, Spinelli M, Laezza F, Grassi C, D'Ascenzo M. Intraneuronal Abeta accumulation induces hippocampal neuron hyperexcitability through A-type K(+) current inhibition mediated by activation of caspases and GSK-3. Neurobiol Aging. 2015 Feb;36(2):886-900. doi: 10.1016/j.neurobiolaging.2014.10.034. Epub 2014 Nov 4.
Background: PubMed 26804914Fusco S, Leone L, Barbati SA, Samengo D, Piacentini R, Maulucci G, Toietta G, Spinelli M, McBurney M, Pani G, Grassi C. A CREB-Sirt1-Hes1 Circuitry Mediates Neural Stem Cell Response to Glucose Availability. Cell Rep. 2016 Feb 9;14(5):1195-1205. doi: 10.1016/j.celrep.2015.12.092. Epub 2016 Jan 21.
Background: PubMed 30870531De Chiara G, Piacentini R, Fabiani M, Mastrodonato A, Marcocci ME, Limongi D, Napoletani G, Protto V, Coluccio P, Celestino I, Li Puma DD, Grassi C, Palamara AT. Recurrent herpes simplex virus-1 infection induces hallmarks of neurodegeneration and cognitive deficits in mice. PLoS Pathog. 2019 Mar 14;15(3):e1007617. doi: 10.1371/journal.ppat.1007617. eCollection 2019 Mar.
Background: PubMed 29321633Mastrodonato A, Barbati SA, Leone L, Colussi C, Gironi K, Rinaudo M, Piacentini R, Denny CA, Grassi C. Olfactory memory is enhanced in mice exposed to extremely low-frequency electromagnetic fields via Wnt/beta-catenin dependent modulation of subventricular zone neurogenesis. Sci Rep. 2018 Jan 10;8(1):262. doi: 10.1038/s41598-017-18676-1.
Background: PubMed 39236310Tropea MR, Melone M, Li Puma DD, Vacanti V, Aceto G, Bandiera B, Trovato RC, Torrisi SA, Leggio GM, Palmeri A, D'Ascenzo M, Conti F, Grassi C, Puzzo D. Blockade of dopamine D3 receptors improves hippocampal synaptic function and rescues age-related cognitive phenotype. Aging Cell. 2024 Nov;23(11):e14291. doi: 10.1111/acel.14291. Epub 2024 Sep 5.
Background: PubMed 39564126Bandiera B, Natale F, Rinaudo M, Sollazzo R, Spinelli M, Fusco S, Grassi C. Olfactory stimulation with multiple odorants prevents stress-induced cognitive and psychological alterations. Brain Commun. 2024 Nov 5;6(6):fcae390. doi: 10.1093/braincomms/fcae390. eCollection 2024.
Background: PubMed 36291221Markov DD. Sucrose Preference Test as a Measure of Anhedonic Behavior in a Chronic Unpredictable Mild Stress Model of Depression: Outstanding Issues. Brain Sci. 2022 Sep 24;12(10):1287. doi: 10.3390/brainsci12101287.
Background: PubMed 37321444Puliatti G, Li Puma DD, Aceto G, Lazzarino G, Acquarone E, Mangione R, D'Adamio L, Ripoli C, Arancio O, Piacentini R, Grassi C. Intracellular accumulation of tau oligomers in astrocytes and their synaptotoxic action rely on Amyloid Precursor Protein Intracellular Domain-dependent expression of Glypican-4. Prog Neurobiol. 2023 Aug;227:102482. doi: 10.1016/j.pneurobio.2023.102482. Epub 2023 Jun 14.
Background: PubMed 35274343Li Puma DD, Ripoli C, Puliatti G, Pastore F, Lazzarino G, Tavazzi B, Arancio O, Piacentini R, Grassi C. Extracellular tau oligomers affect extracellular glutamate handling by astrocytes through downregulation of GLT-1 expression and impairment of NKA1A2 function. Neuropathol Appl Neurobiol. 2022 Aug;48(5):e12811. doi: 10.1111/nan.12811. Epub 2022 Mar 16.
Background: PubMed 25232124Ripoli C, Cocco S, Li Puma DD, Piacentini R, Mastrodonato A, Scala F, Puzzo D, D'Ascenzo M, Grassi C. Intracellular accumulation of amyloid-beta (Abeta) protein plays a major role in Abeta-induced alterations of glutamatergic synaptic transmission and plasticity. J Neurosci. 2014 Sep 17;34(38):12893-903. doi: 10.1523/JNEUROSCI.1201-14.2014.
Related InfoLink provided by the sponsor.
Individual participant dataSharing planned: No. Individual participant data will not be shared outside the research team due to the sensitive nature of the clinical, psychiatric, and biological data collected, including genetic and cellular material derived from patients with Bipolar Disorder. Data protection and confidentiality commitments made to participants during the informed consent process do not include provisions for external data sharing. Aggregate, de-identified results will be disseminated through peer-reviewed publications

Related trials for Bipolar Disorder (BD)

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Gabriele Sani contact

+39 06 30155807

gabriele.sani@policlinicogemelli.it

Gabriele Sani principal investigator

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 29 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Gabriele Sani (+39 06 30155807, gabriele.sani@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intracellular lithium concentration in patient derived neural cells (hiNSCs) treated with LiG-AuNPs versus lithium salts (LiCl) (time frame: 1, 2, 6, 12, and 24 hours after in vitro treatment (assessed throughout the 3-year study period)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07732933, which also lists 15 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jul 2026.