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

NCT03396744 | Unknown Phase 1 DMC

• 1 other identifier: CRC16142
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Bipolar Depression

Outcome Measures

Primary Outcomes (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).

  10 weeks

Secondary Outcomes (14)

• Change in Depression Score

  6, 8 and 10 weeks

• Change in Clinical Global Impressions (CGI)

  6, 8 and 10 weeks

• Change in tolerance

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

• Acceptability

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

• MADRS

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

Study Arms (2)

Morning group

ACTIVE COMPARATOR

Exposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention

Device: Light

Mid-day group

ACTIVE COMPARATOR

Exposition at 8 a.m +/- 30 min, during 10 active weeks, and assessed 6 months after this intervention.

Device: Light

Interventions

Light DEVICE

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

Mid-day group; Morning group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.).
• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Fenand Widal hospital

Paris, 75010, France

RECRUITING

Related Publications (2)

• 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.

  PMID: 40608475 DERIVED

• 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.

  PMID: 30466205 DERIVED

MeSH Terms

Conditions

Bipolar Disorder

Interventions

Ultraviolet Therapy

Condition Hierarchy (Ancestors)

Bipolar and Related Disorders; Mood Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics

Central Study Contacts

Pierre Alexis GEOFFROY, MD

CONTACT

33+140 05 48 81; pierrealexis.geoffroy@aphp.fr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Dose finding study

Study Record Dates

• First Submitted: January 2, 2018
• First Posted: January 11, 2018
• Study Start: September 30, 2019
• Primary Completion: July 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 10, 2020

Record last verified: 2020-02

Locations

FR (1)