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Not yet recruitingNCT07750925HELIOS-BD 2Updated Aug 6, 2026

Examining Lithium's Mechanism in Bipolar Disorder

An interventional study of Lithium carbonate (Priadel) and Controlled light exposure in Healthy and Bipolar, sponsored by Northumbria University. Not yet recruiting at 1 site in United Kingdom. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-06.

Sponsored by Northumbria University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
45
Allocation
Not applicable
Ages
18 Years to 40 Years
Sex
All
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Study 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 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.

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Conditions studied

  • Healthy
  • Bipolar

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Keywords

  • Circadian Rhythms
  • Performance
  • Mood
  • Lithium
  • Light sensitivity
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In context

Photophobia

43 studies on the registry are indexed under Photophobia; 13 are open to participants now.

This study's planned enrollment of 45 is close to the median of 43 across 36 interventional studies indexed under Photophobia.

Browse Photophobia studies →

Lead sponsor

Northumbria University is the lead sponsor of 160 studies on the registry; 22 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • between 18 and 28kg/m2
  • Currently enrolled and registered with a general practitioner
  • Female participants only: should use effective or refrain from engaging in sexual activity that could result in pregnancy during participation in the study.

Exclusion criteria

Exclusion Criteria:

  • 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.
  • 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 (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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

Contraception

Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.

Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

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Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
45 participants (estimated)

Study arms

  • Experimental
    Single Group Assignment

    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.

    Drug: Lithium carbonate (Priadel) · Other: Controlled light exposure

Interventions

  • Oral lithium carbonate 600 mg daily for 7 days prior to the second laboratory assessment (and for both days while in the laboratory)

  • OtherControlled light exposure

    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.

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What researchers measure

Primary outcomes

  1. Plasma melatonin change in response to light stimulation

    Difference in plasma melatonin suppression following light exposure between the no-lithium and lithium conditions.

    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).

  2. 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.

    Time frame: Measured once following 9 days of lithium carbonate administration (Day 21)

Secondary outcomes

  1. 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

    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)

  2. 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.

    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.

  3. 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.

    Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19)

  4. 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.

    Time frame: Measured at screening and following 7 days of lithium administration (screening Stage 2 and Day 19)

  5. 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.

    Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).

  6. 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.

    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).

  7. 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.

    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)

  8. 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.

    Time frame: Measured at screening and following 7 days of lithium administration (screening stage 2 and day 19).

  9. 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.

    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)

  10. 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.

    Time frame: Days 9-11 and 19-21, hourly while awake and before/after the light exposure segments.

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Study locations

1 site
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References and documents

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 10922269 ↗
  • Merikangas 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 30540352 ↗
  • Zisapel 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 12043836 ↗
  • Freedman 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 10205061 ↗
  • Czeisler 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 7990870 ↗
  • Lewy 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 6110011 ↗
  • Ritter 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 36324599 ↗
  • Malhi 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 23371914 ↗
  • Alda 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 25687772 ↗
  • Fountoulakis 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 34980362 ↗
  • Severus 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 25530932 ↗
  • McCarthy 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 34850507 ↗
  • Merikangas 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 ↗

Related links

Individual participant data

Plan to share: 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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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 6, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT07750925
Collaborators
Newcastle University, Northumberland, Tyne and Wear NHS Foundation Trust
Responsible party
Sponsor
First posted
Aug 6, 2026
Start date
Aug 1, 2026 (estimated)
Primary completion
Apr 30, 2028 (estimated)
Completion
Apr 30, 2029 (estimated)
Last update
Aug 6, 2026

Study contacts

Nayantara Santhi
Contact
nayantara.santhi@northumbria.ac.uk
0191 227 4055
Saranea Ganesan
Contact
saranea.g@northumbria.ac.uk
+447587590262

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Lithium Carbonate

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