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Bipolar DepressionPhase 1/2LUBINCT03396744

Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depression

A Phase 1/2 study testing Light in people with Bipolar Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Depressive episodes in BD are frequently refractory and clinicians have few treatment options. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Bipolar Depression
What is being tested?
Light
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
45 participants
Where
1 siteFrance
Study dates
30 Sep 2019to Jan 2021
Phase
Phase 1/2
Are there results?
None posted in the registry

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients must be aged from 18 to 55 year-old.
  • Patients must read and understand French language, and must provide written informed consent.
  • Patients must be inpatients or outpatients followed in psychiatry for a major depressive episodes.
  • Patients must have a diagnosis of bipolar disorder, type I or II, according to the DSM-5 and determined by a SCID.
  • Patients must have a major depressive episode, at least of moderate intensity, according to the DSM-5, with a MADRS total score ≥20 and determined by a SCID.
  • Patients must have a mood stabilizer since at least 4 weeks at standard dosage (lithium, or sodium valproate, or second generation antipsychotics such as quetiapine, aripiprazole, olanzapine).
  • Female patients must be using a medically accepted means of contraception.
  • Patients must be affiliated to the social security scheme.

Who cannot join

  • Patients under guardianship or deprivation of liberty by administrative or judicial decision
  • Seasonal pattern of major depressive episode according to DSM-5 criteria.
  • Psychotic, mixed, or catatonic characteristics according to DSM-5 criteria
  • High suicidal risk assessed by the Columbia Scale of Suicide Risk Severity (C-SSRS)
  • Not stabilized comorbidities (addictive disorders according to the DSM-5 criteria or other decompensated general medical cause).
  • Ophthalmic pathology (cataract, macular degeneration, glaucoma, retinitis pigmentosa) and diseases affecting the retina (retinopathy, diabetes, herpes, etc.).
Show all 21Show fewer
  • Photosensitive treatment, including the following treatments:
  • Cyclins (Vibramycin®, Doxycycline®)
  • Amiodarone (Cordarone®, Amiodarone®)
  • Phenothiazines (Largactil®, Modecate®, Nozinan®, Melleril®, Trilafon®)
  • Methotrexate (Methotrexate®)
  • Sulfamides (antibiotics, diuretics or hypoglycemic agents)
  • Chloroquine (Nivaquine®)
  • Some anti-inflammatories (Apranax®, Indocid®)
  • Psoralens used in puvatherapy
  • Isotretinoin (Roaccutane® and generics)
  • Verteporfin (Visudyne®).
  • Lactating or pregnant women (pregnancy urine positive test).
  • Subjects who have already used light therapy in the last 6 months.
  • Therapeutic resistance of the current major depressive episode (≥2 traditional antidepressants such as SSRI, IRSNA, MAOI or tricyclic, at effective therapeutic dosage for more than 6 weeks)
  • Use of another antidepressant strategy than the mood stabilizer, including antidepressants of all classes (which will have to be stopped before the initiation of light therapy) and psychotherapy with onset <1 month.

Trial locations and contacts

1 site in 1 country.

Pierre Alexis GEOFFROY, MD contact

33+140 05 48 81

pierrealexis.geoffroy@aphp.fr

France1 site, 1 recruiting

  • Fenand Widal hospital

    Paris, 75010

    Pierre Alexis GEOFFROY, MD, Pierrealexis.geoffroy@aphp.fr

    Recruiting

Other trials in France

About this study

Official title: Bright Light Therapy in the Treatment of Non-seasonal Bipolar Depressive Episode of Bipolar Disorder: A Dose Research Phase I/II Trial

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Depressive episodes in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is a promising emerging antidepressant strategy that is lacking evidence-based guidelines for its prescription in BD, including to avoid side effects such as manic switches. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

Read the detailed description

Bipolar disorder (BD) is a severe brain disorder characterized by the recurrence of mood episodes. Patients presenting with BD spend more time with depressive symptoms than with manic ones, which have a major impact on the quality of life and is associated with poorer outcomes including recurrences and suicide. In addition depressive phases in BD are frequently refractory and clinicians have few treatment options. Bright light therapy (BLT, also named phototherapy) is the first line treatment for depression with seasonal patterns and show promising results in the treatment of non-seasonal depressions. More evidence in non-seasonal depressions is expected, especially in BD. Moreover, some specificities linked to BD, such as the manic switch, warrant evidence-based therapeutic guidelines and so deserve more studies in BD. Preliminary reports suggest that morning exposure may induce manic switches, and that mid-day exposures may be associated with a decreased risk of manic switch. Different dose-titration protocols have also not been compared, and data are lacking. In this context, this study aimed to evaluate modalities of the BLT dosage (time of exposure) escalation depending on the tolerance (manic symptoms) in two groups exposed either during the morning or at mid-day.

Being tested
Light
Medical subject headings
Bipolar Disorder

What participants receive

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

  • LightDevice

    Placebo light (50 Lux) during 1 week and then active bright light with glasses using a dosage escalation (inter- and intra-subject) of 7.5, 10, 15, 30 and 45 min

Study groups in NCT03396744
Study groupRoleWhat they receive
Morning groupActive comparatorExposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention
Receives: Device: Light
Mid-day groupActive comparatorExposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention.
Receives: Device: Light

What is being measured

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

  1. Change in Mania Score

    The Young Mania Rating Scale (YMRS) will be used as a measure of tolerance reflecting change in YMRS total scores at each week over the 10 weeks (Total score ≥ 12 defining an hypomanic switch).

    Measured: 10 weeks

Secondary outcomes (14)

  1. Change in Depression Score

    The Montgomery-Asberg Depression Rating Scale (MADRS) will be used as a measure of efficacy reflecting changes from baseline to endpoint

    Measured: 6, 8 and 10 weeks

  2. Change in Clinical Global Impressions (CGI)

    The Clinical Global Impressions (CGI) will be used as a measure of efficacy reflecting changes from baseline to endpoint

    Measured: 6, 8 and 10 weeks

  3. Change in tolerance

    YMRS will be used to evaluate hypomanic switch at 3 days after each duration of exposition change

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks

  4. Acceptability

    measured by auto-questionnaire made by the investigators

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks

  5. MADRS

    The MADRS will be used to evaluate changes of depressive symptoms from baseline

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then at 6 months

  6. Clinical Global Impressions (CGI).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  7. Columbia-Suicide Severity Rating Scale (C-SSRS)

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  8. Quick Inventory of Depressive Symptomatology (QIDS SR-16)

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  9. Altman Self-Rating Mania Scale (ASRM).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  10. Pittsburgh Sleep Quality Index (PSQI).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  11. Composite Scale of Morningness (CSM).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  12. Circadian Type Inventory (CTI).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  13. Epworth Sleepiness Scale (ESS).

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

  14. Side effects: PRISE-M

    Measured: 1, 2, 3, 4, 5, 6, 8 and 10 weeks, and then 6 months

Timeline

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

  1. First posted11 Jan 2018
  2. Study start30 Sep 2019
  3. Primary completionJul 2020 (estimated)
  4. Study completionJan 2021 (estimated)

Resources

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 1/2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Model description
Dose finding study
Masking
None (open label)
Enrolment
45 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03396744
Sponsor's protocol ID
CRC16142
Acronym
LUBI
Status last verified
Feb 2020
First submitted
2 Jan 2018
Last updated
10 Feb 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Geoffroy PA, Chevret S, Mauries S, Chaffaut C, Amad A, Bellivier F, Benard V, Courtet P, Dubertret C, Gorwood P, Mazer N, Mekaoui L, Olie E, Pataud G, Vaiva G, Lejoyeux M, Sit D, Maruani J. Bright Light Therapy in the Morning or Midday for the Treatment of Nonseasonal Depression in Bipolar Disorder (LuBi): A Dose-Escalation Phase 1/2 Randomized Double-Blind Trial. J Clin Psychiatry. 2025 Jun 23;86(3):25m15826. doi: 10.4088/JCP.25m15826.

    PubMed 40608475

  • Geoffroy PA, Abbassi EMBE, Maruani J, Etain B, Lejoyeux M, Amad A, Courtet P, Dubertret C, Gorwood P, Vaiva G, Bellivier F, Chevret S. Bright Light Therapy in the Morning or at Mid-Day in the Treatment of Non-Seasonal Bipolar Depressive Episodes (LuBi): Study Protocol for a Dose Research Phase I / II Trial. Psychiatry Investig. 2018 Dec;15(12):1188-1202. doi: 10.30773/pi.2018.09.27.1. Epub 2018 Nov 26.

    PubMed 30466205

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Light in people with Bipolar Depression, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.

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 21 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: status not confirmed, as of the sponsor's last update on 10 Feb 2020. 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 France. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

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

Contact Pierre Alexis GEOFFROY, MD (33+140 05 48 81, pierrealexis.geoffroy@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Mania Score (time frame: 10 weeks). 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 NCT03396744, which also lists 2 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 10 Feb 2020.

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