HealthyHELIOS-BD 2NCT07750925
Examining Lithium's Mechanism in Bipolar Disorder
A study testing Lithium carbonate (Priadel) in people with Healthy and Bipolar, run by Northumbria University at 1 site in United Kingdom.
Trial summary
The primary objective of the current study is to examine the acute effect of lithium on the visual and non-visual responses to light in a sample of healthy participants. Our experiments will investigate the effects of lithium on light sensitivity at the level of the retina as well as central visual and non-visual… Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- What is being tested?
- Lithium carbonate (Priadel)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2026to 30 Apr 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 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Aged between 18 and 40 years old
- Fluent in English (both spoken and written)
- Sleep duration between 6.5 and 9 hours daily
- Have a regular normal sleep schedule with bedtime (weekdays) between 21:30 and 01:00.
- BMI between 18 and 28kg/m2
- Currently enrolled and registered with a general practitioner
- Female participants only: should use effective contraception or refrain from engaging in sexual activity that could result in pregnancy during participation in the study.
Who cannot join
- History of psychiatric or neurological disorders
- First-degree family history of psychosis or severe mood disorder
- Current or past suicidal ideation or self-harm
- Current, chronic infections or diseases.
- Life-threatening allergies, specifically a nut allergy.
- Known visual disorders e.g., colour blindness, glaucoma, cataracts, diabetic retinopathy.
Show all 29Show fewer
- Known medical conditions that could affect the conduct of the study including
- sleep disorders
- cancer
- diabetes
- anaemia
- epilepsy
- psoriasis
- thyroid disorders
- kidney disease
- severe eczema
- anemia
- migraines
- Taking any long-term or regular medications other than oral contraceptives (e.g., antidepressants, diuretics (water-tablets), pain killers or anti-inflammatory drugs (such as ibuprofen) or medications for high blood pressure).
- Have donated blood in the past 1 month
- Regular or recent recreational drug use
- Chronic alcohol addiction/misuse
- Known contraindication to magnetic resonance imaging such as pacemaker or metal implants, recent surgery, severe claustrophobia and/or recent head or neck tattoos.
- A current smoker (including use of cigarettes, vapes, and/or cigars).
- Planning to travel across time zones at any point in time during the conduct of the study or have travelled across time zones within 1 month prior to enrolment.
- Currently work night shifts
- Been a shift worker in the past 3 months.
- Current enrolment in any other interventional studies
- Enrolment in any other interventional studies in the 1 month prior to the start of participation in this study
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Northumbria University
Newcastle upon Tyne, Tyne & Wear, NE1 8SG
Nayantara Santhi, 0191 227 4055, nayantara.santhi@northumbria.ac.uk
Saranea Ganesan, +447587590262, saranea.g@northumbria.ac.uk
About this study
Official title: Investigating the Acute Effect of Lithium on Visual and Non-visual Responses to Light in Healthy Individuals
The primary objective of the current study is to examine the acute effect of lithium on the visual and non-visual responses to light in a sample of healthy participants. Our experiments will investigate the effects of lithium on light sensitivity at the level of the retina as well as central visual and non-visual pathways.
Our primary hypothesis is that the administration of lithium to healthy volunteers will reduce the magnitude of a range of non-visual responses to light including melatonin suppression, alertness, performance, mood and electrophysiology in a manner that is dependent of the amount of lithium in the brain. To better understand the postulated effects of lithium on light sensitivity and to examine its relationship at the level of the retina, we will assess the visual and non-visual responses to light, as well as the distribution of lithium in the brain using a non-invasive imaging technique. In addition to that, we also aim to examine the impact of both lithium and light on a molecular level through whole blood transcriptome sequencing.
- Being tested
- Lithium carbonate (Priadel), Controlled light exposure
- Keywords
- Circadian Rhythms, Performance, Mood, Lithium, Light sensitivity
- Medical subject headings
- Photophobia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lithium carbonate (Priadel)Drug
Oral lithium carbonate 600 mg daily for 7 days prior to the second laboratory assessment (and for both days while in the laboratory)
Controlled light exposureOther
Participants undergo 90-minute dim light (<1 lux) and light exposure (100-850 lux) conditions during laboratory assessments to evaluate visual and non-visual responses to light.
| Study group | Role | What they receive |
|---|---|---|
| Single Group Assignment | Experimental | All participants will complete a no-lithium condition (control) followed by a lithium condition (intervention). During both conditions, visual and non-visual responses to controlled light exposure are assessed. Receives: Drug: Lithium carbonate (Priadel); Other: Controlled light exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma melatonin change in response to light stimulation
Difference in plasma melatonin suppression following light exposure between the no-lithium and lithium conditions.
Measured: Measured during the 90-minute light exposure session after 7 days of lithium treatment and after 7 days in the no-lithium condition (days 9-11 and 19-21).
Brain lithium signal intensity measured by 7Li-MRI
Quantification of brain lithium signal intensity using 7Li magnetic resonance imaging following 9 days of lithium carbonate administration in healthy participants.
Measured: Measured once following 9 days of lithium carbonate administration (Day 21)
Secondary outcomes (10)
Difference in colour vision post-light exposure between lithium and no-lithium conditions
To determine differences in the Cambridge Colour Test (CCT) for changes in colour vision between the lithium and placebo groups post light exposure
Measured: Measured immediately following the 90-minute light exposure session after 7 days in the lithium condition and after 7 days in the no-lithium condition (days 9-11 and 19-21)
Waking EEG Measures
Hourly waking electroencephalography (EEG) data collected when the participant is awake in the lab will be compared between the lithium and no-lithium conditions. EEG data collected pre, post and during the 90-minute light exposure will be compared between the lithium and no-lithium conditions.
Measured: EEG recordings will occur pre, post and throughout the 90-minute light exposure during days 9-11 and 19-21. EEG recordings will be conducted hourly when the participant is awake in the laboratory.
Pittsburgh Sleep Quality Index
Difference in Pittsburgh Sleep Quality Index total score between the lithium and no-lithium conditions in healthy participants. The global score on ranges from 0 to 21, where higher scores represent poorer sleep quality.
Measured: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19)
Munich Chronotype Questionnaire
Difference in Munich Chronotype Questionnaire(MCTQ) measures between the lithium and no-lithium conditions in healthy participants. Total score on the MCTQ ranges from 16 to 86, with 16 to 41 being the eveningness type, 42 to 58 being the intermediate type, and 59 to 86 being the morningness type.
Measured: Measured at screening and following 7 days of lithium administration (screening Stage 2 and Day 19)
General Health Questionnaire - 12
Difference in General Health Questionnaire-12 (GHQ-12) total score between the lithium and no-lithium conditions in healthy participants. The responses to all items are summed up to a total score of 0 to 36, with higher scores indicating poorer health status.
Measured: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).
Karolinska Sleepiness Scale
Difference in Karolinska Sleepiness Scale scores following light exposure between the lithium and no-lithium conditions in healthy participants. The scores range from 1 (extremely alert) to 9 (very sleepy, fighting sleep), with higher scores indicating increased sleepiness.
Measured: Measured during and immediately following the 90-minute light exposure session after 7 days in the no-lithium condition and after 7 days of lithium administration (days 9-11 and 19-21).
Psychomotor Vigilance Test
Difference in Psychomotor Vigilance Test (PVT) pre and post light exposure between the lithium and no-lithium conditions in healthy participants will be compared. Mean reaction time (RT), lapses (RT > 500ms), and false starts (responses before stimulus or <100 ms) will be analysed. A higher mean RT and a greater number of lapses on the task represent poorer alertness and performance.
Measured: Measured immediately following the 90-minute light exposure session after 7 days in the no-lithium condition and after 7 days of lithium administration. (And hourly while awake in the laboratory) (Days 9-11 and 19-21)
Morningness-Eveningness Questionnaire
This task is a measure of chronotype. Difference in Morningness-Eveningness Questionnaire total score between the lithium and no-lithium conditions in healthy participants. The score on this task ranges from 16 to 86. A score of 16-41 represents an evening person. A score of 59-86 represents a morning person and a score of 42 to 58 represents an intermediate person.
Measured: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).
Reading the Mind in the Eyes
This task will help assess a person's ability to interpret the emotional state of others based solely on images of their eyes, essentially measuring their "Theory of Mind" (ToM) - the capacity to understand and attribute thoughts and feelings to others.
Measured: This task will be implemented during the laboratory segment of the lithium and no-lithium condition. The task will be implemented hourly when the participant is awake in the laboratory. (Days 9-11 and Days 19-21)
Karolinska Drowsiness Test
Drowsiness will be assessed with EEG data when the Karolinska Drowsiness Test is implemented. The Alpha and Theta power density, the Alpha Attenuation Coefficient (AAC), and the Alpha-Theta power differences will be assessed and analysed.
Measured: Days 9-11 and 19-21, hourly while awake and before/after the light exposure segments.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion30 Apr 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (13)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Block design experiment with no lithium condition followed by lithium condition.
- Masking
- None (open label)
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Newcastle University, Northumberland, Tyne and Wear NHS Foundation Trust
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750925
- Sponsor's protocol ID
- 333056
- Other IDs
- 226787/Z/22/Z
- Acronym
- HELIOS-BD 2
- Status last verified
- Jun 2026
- First submitted
- 16 Jun 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is currently no plan to make IPD available. However, if researchers would like to have access to IPD, they can make a request to Northumbria University and the request will be appropriately reviewed.
Publications
Zeitzer JM, Dijk DJ, Kronauer R, Brown E, Czeisler C; New Collective Author. Sensitivity of the human circadian pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol. 2000 Aug 1;526 Pt 3(Pt 3):695-702. doi: 10.1111/j.1469-7793.2000.00695.x.
PubMed 10922269Merikangas KR, Swendsen J, Hickie IB, Cui L, Shou H, Merikangas AK, Zhang J, Lamers F, Crainiceanu C, Volkow ND, Zipunnikov V. Real-time Mobile Monitoring of the Dynamic Associations Among Motor Activity, Energy, Mood, and Sleep in Adults With Bipolar Disorder. JAMA Psychiatry. 2019 Feb 1;76(2):190-198. doi: 10.1001/jamapsychiatry.2018.3546.
PubMed 30540352Zisapel N. Melatonin-dopamine interactions: from basic neurochemistry to a clinical setting. Cell Mol Neurobiol. 2001 Dec;21(6):605-16. doi: 10.1023/a:1015187601628.
PubMed 12043836Freedman MS, Lucas RJ, Soni B, von Schantz M, Munoz M, David-Gray Z, Foster R. Regulation of mammalian circadian behavior by non-rod, non-cone, ocular photoreceptors. Science. 1999 Apr 16;284(5413):502-4. doi: 10.1126/science.284.5413.502.
PubMed 10205061Czeisler CA, Shanahan TL, Klerman EB, Martens H, Brotman DJ, Emens JS, Klein T, Rizzo JF 3rd. Suppression of melatonin secretion in some blind patients by exposure to bright light. N Engl J Med. 1995 Jan 5;332(1):6-11. doi: 10.1056/NEJM199501053320102.
PubMed 7990870Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Rosenthal NE. Manic-depressive patients may be supersensitive to light. Lancet. 1981 Feb 14;1(8216):383-4. doi: 10.1016/s0140-6736(81)91697-4. No abstract available.
PubMed 6110011Ritter P, Soltmann B, Sauer C, Yakac A, Boekstaegers L, Reichard M, Koenitz K, Bauer M, Guldner H, Neumann S, Wieland F, Skene DJ. Supersensitivity of Patients With Bipolar I Disorder to Light-Induced Phase Delay by Narrow Bandwidth Blue Light. Biol Psychiatry Glob Open Sci. 2021 Jun 19;2(1):28-35. doi: 10.1016/j.bpsgos.2021.06.004. eCollection 2022 Jan.
PubMed 36324599Malhi GS, Tanious M, Das P, Coulston CM, Berk M. Potential mechanisms of action of lithium in bipolar disorder. Current understanding. CNS Drugs. 2013 Feb;27(2):135-53. doi: 10.1007/s40263-013-0039-0.
PubMed 23371914Alda M. Lithium in the treatment of bipolar disorder: pharmacology and pharmacogenetics. Mol Psychiatry. 2015 Jun;20(6):661-70. doi: 10.1038/mp.2015.4. Epub 2015 Feb 17.
PubMed 25687772Fountoulakis KN, Tohen M, Zarate CA Jr. Lithium treatment of Bipolar disorder in adults: A systematic review of randomized trials and meta-analyses. Eur Neuropsychopharmacol. 2022 Jan;54:100-115. doi: 10.1016/j.euroneuro.2021.10.003.
PubMed 34980362Severus E, Taylor MJ, Sauer C, Pfennig A, Ritter P, Bauer M, Geddes JR. Lithium for prevention of mood episodes in bipolar disorders: systematic review and meta-analysis. Int J Bipolar Disord. 2014 Dec 20;2:15. doi: 10.1186/s40345-014-0015-8. eCollection 2014.
PubMed 25530932McCarthy MJ, Gottlieb JF, Gonzalez R, McClung CA, Alloy LB, Cain S, Dulcis D, Etain B, Frey BN, Garbazza C, Ketchesin KD, Landgraf D, Lee HJ, Marie-Claire C, Nusslock R, Porcu A, Porter R, Ritter P, Scott J, Smith D, Swartz HA, Murray G. Neurobiological and behavioral mechanisms of circadian rhythm disruption in bipolar disorder: A critical multi-disciplinary literature review and agenda for future research from the ISBD task force on chronobiology. Bipolar Disord. 2022 May;24(3):232-263. doi: 10.1111/bdi.13165. Epub 2021 Dec 10.
PubMed 34850507Merikangas KR, Jin R, He JP, Kessler RC, Lee S, Sampson NA, Viana MC, Andrade LH, Hu C, Karam EG, Ladea M, Medina-Mora ME, Ono Y, Posada-Villa J, Sagar R, Wells JE, Zarkov Z. Prevalence and correlates of bipolar spectrum disorder in the world mental health survey initiative. Arch Gen Psychiatry. 2011 Mar;68(3):241-51. doi: 10.1001/archgenpsychiatry.2011.12.
PubMed 21383262
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Acute Effect of Lithium on Visual and Non-visual Responses to Light in Healthy Individuals
- ClinicalTrials.gov ID
- NCT07750925
- Acronym / sponsor ID
- HELIOS-BD 2 / 333056
- Keywords
- Circadian Rhythms, Performance, Mood, Lithium, Light sensitivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Newcastle University, Northumberland, Tyne and Wear NHS Foundation Trust
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 30 Apr 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 6 Aug 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.
The primary objective of the current study is to examine the acute effect of lithium on the visual and non-visual responses to light in a sample of healthy participants. Our experiments will investigate the effects of lithium on light sensitivity at the level of the retina as well as central visual and non-visual pathways.
Our primary hypothesis is that the administration of lithium to healthy volunteers will reduce the magnitude of a range of non-visual responses to light including melatonin suppression, alertness, performance, mood and electrophysiology in a manner that is dependent of the amount of lithium in the brain. To better understand the postulated effects of lithium on light sensitivity and to examine its relationship at the level of the retina, we will assess the visual and non-visual responses to light, as well as the distribution of lithium in the brain using a non-invasive imaging technique. In addition to that, we also aim to examine the impact of both lithium and light on a molecular level through whole blood transcriptome sequencing.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Block design experiment with no lithium condition followed by lithium condition.
| Arm | Type | Receives |
|---|---|---|
| Single Group Assignment | Experimental | Drug: Lithium carbonate (Priadel), Other: Controlled light exposureAll participants will complete a no-lithium condition (control) followed by a lithium condition (intervention). During both conditions, visual and non-visual responses to controlled light exposure are assessed. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Aged between 18 and 40 years old
- Fluent in English (both spoken and written)
- Sleep duration between 6.5 and 9 hours daily
- Have a regular normal sleep schedule with bedtime (weekdays) between 21:30 and 01:00.
- BMI between 18 and 28kg/m2
Key exclusion criteria (29 listed)
- History of psychiatric or neurological disorders
- First-degree family history of psychosis or severe mood disorder
- Current or past suicidal ideation or self-harm
- Current, chronic infections or diseases.
- Life-threatening allergies, specifically a nut allergy.
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 |
|---|---|---|
| Lithium carbonate (Priadel)Oral lithium carbonate 600 mg daily for 7 days prior to the second laboratory assessment (and for both days while in the laboratory) | Drug | Single Group Assignment |
| Controlled light exposureParticipants undergo 90-minute dim light (<1 lux) and light exposure (100-850 lux) conditions during laboratory assessments to evaluate visual and non-visual responses to light. | Other | Single Group Assignment |
Primary outcome
Plasma melatonin change in response to light stimulation
Time frame: Measured during the 90-minute light exposure session after 7 days of lithium treatment and after 7 days in the no-lithium condition (days 9-11 and 19-21).
Difference in plasma melatonin suppression following light exposure between the no-lithium and lithium conditions.
Brain lithium signal intensity measured by 7Li-MRI
Time frame: Measured once following 9 days of lithium carbonate administration (Day 21)
Quantification of brain lithium signal intensity using 7Li magnetic resonance imaging following 9 days of lithium carbonate administration in healthy participants.
10 secondary outcomes
Difference in colour vision post-light exposure between lithium and no-lithium conditions
Time frame: Measured immediately following the 90-minute light exposure session after 7 days in the lithium condition and after 7 days in the no-lithium condition (days 9-11 and 19-21)
Waking EEG Measures
Time frame: EEG recordings will occur pre, post and throughout the 90-minute light exposure during days 9-11 and 19-21. EEG recordings will be conducted hourly when the participant is awake in the laboratory.
Pittsburgh Sleep Quality Index
Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19)
Munich Chronotype Questionnaire
Time frame: Measured at screening and following 7 days of lithium administration (screening Stage 2 and Day 19)
General Health Questionnaire - 12
Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).
Karolinska Sleepiness Scale
Time frame: Measured during and immediately following the 90-minute light exposure session after 7 days in the no-lithium condition and after 7 days of lithium administration (days 9-11 and 19-21).
Psychomotor Vigilance Test
Time frame: Measured immediately following the 90-minute light exposure session after 7 days in the no-lithium condition and after 7 days of lithium administration. (And hourly while awake in the laboratory) (Days 9-11 and 19-21)
Morningness-Eveningness Questionnaire
Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).
Reading the Mind in the Eyes
Time frame: This task will be implemented during the laboratory segment of the lithium and no-lithium condition. The task will be implemented hourly when the participant is awake in the laboratory. (Days 9-11 and Days 19-21)
Karolinska Drowsiness Test
Time frame: Days 9-11 and 19-21, hourly while awake and before/after the light exposure segments.
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 6 Aug 2026.
- Background: PubMed 10922269Zeitzer JM, Dijk DJ, Kronauer R, Brown E, Czeisler C; New Collective Author. Sensitivity of the human circadian pacemaker to nocturnal light: melatonin phase resetting and suppression. J Physiol. 2000 Aug 1;526 Pt 3(Pt 3):695-702. doi: 10.1111/j.1469-7793.2000.00695.x.
- Background: PubMed 30540352Merikangas KR, Swendsen J, Hickie IB, Cui L, Shou H, Merikangas AK, Zhang J, Lamers F, Crainiceanu C, Volkow ND, Zipunnikov V. Real-time Mobile Monitoring of the Dynamic Associations Among Motor Activity, Energy, Mood, and Sleep in Adults With Bipolar Disorder. JAMA Psychiatry. 2019 Feb 1;76(2):190-198. doi: 10.1001/jamapsychiatry.2018.3546.
- Background: PubMed 12043836Zisapel N. Melatonin-dopamine interactions: from basic neurochemistry to a clinical setting. Cell Mol Neurobiol. 2001 Dec;21(6):605-16. doi: 10.1023/a:1015187601628.
- Background: PubMed 10205061Freedman MS, Lucas RJ, Soni B, von Schantz M, Munoz M, David-Gray Z, Foster R. Regulation of mammalian circadian behavior by non-rod, non-cone, ocular photoreceptors. Science. 1999 Apr 16;284(5413):502-4. doi: 10.1126/science.284.5413.502.
- Background: PubMed 7990870Czeisler CA, Shanahan TL, Klerman EB, Martens H, Brotman DJ, Emens JS, Klein T, Rizzo JF 3rd. Suppression of melatonin secretion in some blind patients by exposure to bright light. N Engl J Med. 1995 Jan 5;332(1):6-11. doi: 10.1056/NEJM199501053320102.
- Background: PubMed 6110011Lewy AJ, Wehr TA, Goodwin FK, Newsome DA, Rosenthal NE. Manic-depressive patients may be supersensitive to light. Lancet. 1981 Feb 14;1(8216):383-4. doi: 10.1016/s0140-6736(81)91697-4. No abstract available.
- Background: PubMed 36324599Ritter P, Soltmann B, Sauer C, Yakac A, Boekstaegers L, Reichard M, Koenitz K, Bauer M, Guldner H, Neumann S, Wieland F, Skene DJ. Supersensitivity of Patients With Bipolar I Disorder to Light-Induced Phase Delay by Narrow Bandwidth Blue Light. Biol Psychiatry Glob Open Sci. 2021 Jun 19;2(1):28-35. doi: 10.1016/j.bpsgos.2021.06.004. eCollection 2022 Jan.
- Background: PubMed 23371914Malhi GS, Tanious M, Das P, Coulston CM, Berk M. Potential mechanisms of action of lithium in bipolar disorder. Current understanding. CNS Drugs. 2013 Feb;27(2):135-53. doi: 10.1007/s40263-013-0039-0.
- Background: PubMed 25687772Alda M. Lithium in the treatment of bipolar disorder: pharmacology and pharmacogenetics. Mol Psychiatry. 2015 Jun;20(6):661-70. doi: 10.1038/mp.2015.4. Epub 2015 Feb 17.
- Background: PubMed 34980362Fountoulakis KN, Tohen M, Zarate CA Jr. Lithium treatment of Bipolar disorder in adults: A systematic review of randomized trials and meta-analyses. Eur Neuropsychopharmacol. 2022 Jan;54:100-115. doi: 10.1016/j.euroneuro.2021.10.003.
- Background: PubMed 25530932Severus E, Taylor MJ, Sauer C, Pfennig A, Ritter P, Bauer M, Geddes JR. Lithium for prevention of mood episodes in bipolar disorders: systematic review and meta-analysis. Int J Bipolar Disord. 2014 Dec 20;2:15. doi: 10.1186/s40345-014-0015-8. eCollection 2014.
- Background: PubMed 34850507McCarthy MJ, Gottlieb JF, Gonzalez R, McClung CA, Alloy LB, Cain S, Dulcis D, Etain B, Frey BN, Garbazza C, Ketchesin KD, Landgraf D, Lee HJ, Marie-Claire C, Nusslock R, Porcu A, Porter R, Ritter P, Scott J, Smith D, Swartz HA, Murray G. Neurobiological and behavioral mechanisms of circadian rhythm disruption in bipolar disorder: A critical multi-disciplinary literature review and agenda for future research from the ISBD task force on chronobiology. Bipolar Disord. 2022 May;24(3):232-263. doi: 10.1111/bdi.13165. Epub 2021 Dec 10.
- Project WebsiteLink provided by the sponsor.
- Individual participant dataSharing planned: No. There is currently no plan to make IPD available. However, if researchers would like to have access to IPD, they can make a request to Northumbria University and the request will be appropriately reviewed.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lithium carbonate (Priadel) in people with Healthy and Bipolar, run by Northumbria University at 1 site in United Kingdom.
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 7 inclusion and 29 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 6 Aug 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 United Kingdom. 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 Nayantara Santhi (0191 227 4055, nayantara.santhi@northumbria.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plasma melatonin change in response to light stimulation (time frame: Measured during the 90-minute light exposure session after 7 days of lithium treatment and after 7 days in the no-lithium condition (days 9-11 and 19-21).). The study lists 2 primary outcomes in all. 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 NCT07750925, which also lists 13 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 6 Aug 2026; AzTrials last refreshed its copy on 6 Nov 2026.