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

Primary Purpose

Bipolar Depression

Status

Unknown status

Phase

Phase 1

Locations

France

Study Type

Interventional

Intervention

Light

About this trial

This is an interventional treatment trial for Bipolar Depression

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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.

Exclusion Criteria:

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
- 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.

Sites / Locations

Fenand Widal hospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Morning group

Mid-day group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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

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

Change in tolerance

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

Acceptability

measured by auto-questionnaire made by the investigators

MADRS

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

Clinical Global Impressions (CGI).

Columbia-Suicide Severity Rating Scale (C-SSRS)

Quick Inventory of Depressive Symptomatology (QIDS SR-16)

Altman Self-Rating Mania Scale (ASRM).

Pittsburgh Sleep Quality Index (PSQI).

Composite Scale of Morningness (CSM).

Circadian Type Inventory (CTI).

Epworth Sleepiness Scale (ESS).

Side effects: PRISE-M

Full Information

NCT ID

NCT03396744

First Posted

January 2, 2018

Last Updated

February 7, 2020

Sponsor

Assistance Publique - Hôpitaux de Paris

1. Study Identification

Unique Protocol Identification Number

NCT03396744

Brief Title

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

Acronym

LUBI

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2020

Overall Recruitment Status

Unknown status

Study Start Date

September 30, 2019 (Actual)

Primary Completion Date

July 2020 (Anticipated)

Study Completion Date

January 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Assistance Publique - Hôpitaux de Paris

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Bipolar Depression

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Single Group Assignment

Model Description

Dose finding study

Masking

None (Open Label)

Allocation

Randomized

Enrollment

45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Morning group

Arm Type

Active Comparator

Arm Description

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

Arm Title

Mid-day group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Light

Intervention Description

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

Primary Outcome Measure Information:

Title

Change in Mania Score

Description

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).

Time Frame

10 weeks

Secondary Outcome Measure Information:

Title

Change in Depression Score

Description

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

Time Frame

6, 8 and 10 weeks

Title

Change in Clinical Global Impressions (CGI)

Description

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

Time Frame

6, 8 and 10 weeks

Title

Change in tolerance

Description

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

Time Frame

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

Title

Acceptability

Description

measured by auto-questionnaire made by the investigators

Time Frame

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

Title

MADRS

Description

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

Time Frame

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

Title

Clinical Global Impressions (CGI).

Time Frame